cyrilzakka/clinical-trials huggingface dataset:
Tools to Identify People At Risk or Already Infected with HIV and HCV

Wedge-Shaped Clusterded Randomizad Trial to Evaluate Two Tools to identify People at Risk or already Infected with HIV and HCV

Objectives: To reduce hidden and incident HIV and HCV infection, through the implementation of a risk and indicator conditions self-questionnaire SQ-R\&IC for HIV and HCV infection, in addition to rapid HIV and HCV serological tests (RT), in the Health Centers (HC). Methodology: stepped-wedge cluster randomized trial in 8 CS of the community of Madrid, to to know if the implementation of the 2 tools described above, improve risk identification and subsequent screening for HIV and HCV infection. In the standard of care branch (SOC), the health personnel will ask people a series of questions to identify the HIV risk exposition, and also they will be provided pop-up computer alerts of HIV indicator conditions in the electronic medical record, moreover HIV and HCV serological tests will be carried out in the reference laboratory, while in the intervention branch in addition to the SOC, a SQ-R\&IC of HIV and HCV will be made available to the HC population, through a quick response (QR) code, as well as HIV and HCV RT. The variables that will be compared are the percentage of HIV and HCV tests performed, of people referred to receive PrEP, and of new HIV and HCV diagnoses or not linked to care that are made during the periods assigned to the EDC branch vs. those in the intervention branch.

Eligibility Criteria:
Inclusion Criteria:

- 14-65 years in the health area or who are captured for inclusion by health personnel. They give their consent to participate.

Exclusion Criteria:

* Having already been included in the study, not signing the consent.
Phase II of Efficacy and Toxicity of Maintenance Sub. Rituximab After Induction in Relapsed MCL and Non-eligible HSCT

1. Primary endpoint: Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy
2. Secondary endpoints:

   1. Quality of response obtained after subcutaneous Rituximab maintenance.
   2. Progression-Free Survival (PFS)
   3. Overall Survival (OS)
   4. Time to Next Therapy (TTNT)
   5. Value of MRD in the disease outcome
   6. Toxicity

This is a phase II trial evaluating the role of maintenance with subcutaneous Rituximab in patients with stage II-IV relapsed or refractory mantle-cell lymphoma with complete or partial response after the administration of a salvage regimen with R-GemOx-D.

Before the study start and in order to standardize the results, the same R-GemOx-D salvage regimen will be used: Rituximab: 375 mg/m2 on day 1, Gemcitabine: 1000 mg/m2 on day 2 (over 30 minutes) and Oxaliplatin: 100 mg/m2 on day 2 (over 3 hours), Dexamethasone 20 mg on day 1-3. Cycles should be repeated every 14 days, up to 8 cycles.

Patients who present a complete or partial response, after the salvage therapy, will start the study receiving subcutaneous Rituximab maintenance at dose of: 1400 mg every 2 months for 2 years; the study treatment will start 6-8 weeks after finishing the salvage therapy.

Patients will be evaluated every 2 months during treatment study phase and every 4 months in the follow up phase. More details in Appendix 1 (Schedule of Assessments)

Eligibility Criteria:
Inclusion Criteria:

* Basal diagnosis of mantle-cell lymphoma in relapse or refractory.
* Achievement of a CR or PR after salvage therapy with R-GemOxD (6 to 8 cycles) as previously described4-5.
* Age \> 18 years.
* One or maximum two prior chemotherapy or immunochemotherapy lines.
* Patients should not be considered candidates for high-dose chemotherapy and autologous stem-cell transplantation.
* No clinical evidence of CNS involvement
* Signed informed consent
* Serum creatinine less than 2 and/or bilirrubin less than 2.5 UNL.
* Pregnant or lactating woman. FCBP must agree to ongoing pregnancy testing during the course or study and commit to use effective contraception during the study

Exclusion Criteria:

* Prior organ transplantation.
* HIV positive.
* HBV related disease
* Any serious active disease or co-morbid medical condition (according to the investigator's decision)
* Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 cervix carcinoma.
* Less than 50% of tumor response.
* Platelet counts less than 50 x 109/L.
* Neutrophil counts less than 1.0 x 109/L.
Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting

Different studies suggest that early enteral nutrition (EEN) has benefits in reducing infectious complications, there is no data that addresses whether delayed enteral nutrition (EN) is detrimental and if it may have effects on inflammatory responses and immune function.


Eligibility Criteria:
Inclusion Criteria:

* having a fasting time of more than 14 days
* American Society of Anesthesiologists (ASA) physical status ranging between 1 and 3, and their condition allows enteral nutrition therapy.

Exclusion Criteria:

* chronic renal failure (peritoneal or hemodialysis or creatinine \> 2.5 mg/dl)
* history of chronic obstructive pulmonary disease
* hepatic dysfunction or cirrhosis or a bilirubin value \> 3 mg/dl
* metabolic diseases,severe anemia
* blood coagulation dysfunction
* pregnancy lactation
* history of psychiatric illness
* patients underwent immunosuppressive therapy
Use of Desmopressin Prior to Graft Kidney Biopsy in Patients with High Risk of Bleeding

The goal of this study is to evaluate the efficacy and safety of desmopressin to prevent bleeding after percutaneous renal graft biopsy in patients at high risk of bleeding.

Researchers will compare desmopressin (DDAVP) to placebo to see if the drug reduces the risk of bleeding events related to kidney biopsy.

Participants will receive intravenous desmopressin medication (100ml) or placebo (100mL of saline solution) before the kidney biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant patients with GFR \&lt;60ml/min/1,73m²
* Need for graft biopsy as indicated by the kidney transplant medical team
* Platelets \&gt;80.000 cells/mm³
* Blood pressure levels controlled before the procedure
* Normal coagulogram levels

Exclusion Criteria:

* Pregnant women
* Prior history of allergic reaction to DDAVP
* Use of prohibitive medications in screening: warfarin, direct oral anticoagulants, unfractionated and low molecular weight heparin in full anticoagulation doses
* History of previous blood dyscrasias
Acetaminophen IV vs Hydromorphone IV in the ED

The purpose of the current study is to compare the analgesic efficacy of intravenous acetaminophen and intravenous hydromorphone in the treatment of acute pain in the ED.

This is a randomized, double-blind placebo-controlled clinical trial comparing intravenous acetaminophen and intravenous hydromorphone in the treatment of acute pain in the Emergency Department. Enrolled subjects presenting to the ED with acute pain will be randomized to receive either acetaminophen 1g IV or hydromorphone 1mg IV.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 through 64 years of age: This is a study of adult ED patients.
* Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in the ED literature.
* ED attending physician's judgment that the patient's pain warrants IV opioids.
* ED attending physician's judgment that the patient has capacity to provide informed consent.
* Patients must be able to understand English or Spanish.

Exclusion Criteria:

* Use of opioids or tramadol within past 24 hours.
* Use of acetaminophen or non-steroidal anti-inflammatory medication within the previous 8 hours.
* Prior adverse reaction to opioids or acetaminophen.
* Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
* Medical condition that might affect metabolism or opioid analgesics or acetaminophen such as hepatitis, renal insufficiency or failure, hypo- or hyper-thyroidism, Addison's or Cushing's disease
* Pregnant or breastfeeding
* Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
* SBP \<100 mmHg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
* HR \< 60/min: Opioids can cause bradycardia.
* Oxygen saturation \< 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
* Use of MAO inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
* Patients using transdermal pain patches: pain patches may influence both the amount of pain patients report as well as the level of relief they obtain from other treatments.
* Taking any medication that might interact with one of the study medications, such as SSRI or tricyclic anti-depressants, antipsychotics, anti-malarial medications (quinidine or halofantrine), amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine or St. John's Wort.
* Patients who have been previously enrolled in this same study: Patients may only be enrolled once.
Study of Anti-CD19 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma

This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti CD19 CAR NK cells in patients with relapsed refractory B cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. CD19 (+) B cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry
2. Previously accepted ≥ first-line regimen chemotherapy
3. Unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation
4. Over 18 years old and under 70 years old
5. The expected survival period is more than 3 months.
6. ECOG≤2
7. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no abnormal electrocardiogram; blood oxygen saturation ≥90%; creatinine clearance ≥40 mL/min; ALT and AST≤3 times normal range, Total bilirubin ≤ 2.0 mg / dL;
8. Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L;
9. The pregnancy test for women of childbearing age must be negative; both men and women must agree to use effective contraception during the treatment period and for the following 1 year.
10. Measurable target lesion

Exclusion Criteria:

1. Patients with extramedullary relapse
2. Burkitt's lymphoma/leukemia
3. Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19 treatment;
4. Liver and kidney function:

   * Total bilirubin \> 2 x ULN (Gilbert Syndrome \> 3 x ULN)
   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 3 × ULN
   * Serum creatinine clearance \>60 mL/min
5. Serological examination:

   * Absolute neutrophil count (ANC) \<0.75x109/L
   * Platelet count (PLT) \<50x109/L
6. Active hepatitis B (HBV-DNA \> 1000 copies / mL), hepatitis C, or uncontrolled infection
7. GVHD ≥ 2 or anti-GVHD treatment
8. IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before infusion, such as donor lymphocyte infusion;
9. Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks
10. Active CNS disease (tumor cells in CSF, but \< 5 WBCs/mL can be included);
11. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation
12. Creatinine \> 1.5 times normal upper limit or ALT / AST \> 3 times normal upper limit or bilirubin \> 2 times normal upper limit
13. New York Heart Association (NYHA) graded above or above
14. Uncontrollable diabetes
15. Suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining
16. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results
A Study to Determine the Variability of a 6-Minute Walk Test in Cystic Fibrosis Subjects With Advanced Lung Disease

This is an observational study to be conducted at approximately 25 sites in the United States. Approximately 25 subjects with severe obstructive CF lung disease (FVC \<40% predicted) will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Males or females who will be \>=14 years old at Visit 3
* A proven diagnosis of CF as evidenced by a positive sweat test (sweat sodium or chloride \>60 mEq/L by quantitative pilocarpine iontophoresis), or genotype and clinical symptoms consistent with the diagnosis of CF
* Able to perform reproducible spirometry maneuvers at Visit 1 in accordance with the American Thoracic Society (coefficient of variation for three FEV1 maneuvers \<=0.2)
* FVC \<40% predicted for height, age and sex at Visit 1
* On a stable regimen of chest physiotherapy (CPT) begun at least 7 days prior to Visit 1
* Able to complete the 6-minute walk test at Visit 1

Exclusion Criteria:

* Use of an investigational drug or device within 28 days prior to Visit 1
* Experiencing an episode of severe acute respiratory failure, as determined by the investigator
Norwegian Occipital Ischemic Stroke Study

Patients who suffer an ischemic stroke in the occipital lobe often experience Visual Field defects. Visual Field defects are negatively correlated to falling, institutionalisation, rehabilitation outcome and quality of life. Patients are often not properly examined and seldom receive rehabilitation. NOR-OCCIP aims to evaluate the Natural history of Visual Field defects after occipital infarction and to determine whether rehabilitation is effective.

BACKGROUND: Visual Field defects after cerebral infarction is an increasingly acknowledged problem, which has consequences for patient outcome. The aim of the Norwegian Occipital Ischemic Stroke Study (NOR-OCCIP) is to: 1.) Improve clinical diagnostics and management of visual field defects in occipital stroke. 2.) Identify and estimate the need for visual rehabilitation among patients with VFD by studying the natural course and the rate of spontaneous recovery. 3.) Study the effect of visual rehabilitation both on visual function as well as on quality of life. METHODS: Patients with acute ischemic occipital stroke on MRI are recruited from Bergen, Stavanger and Trondheim. Patients are included for a period of 1.5 years, starting August 15th 2013. Patients are eligible for inclusion if \>18 years, written consent is obtained and the patient is able to co-operate to examination with autoperimetry. Within one week patients are examined by ophthalmologist after a standardized protocol including autoperimetry. During week four patients are examined by vision teacher after a standardized protocol and a structured interview on vision specific function and quality of life (VFQ-25) is conducted by a study nurse via telephone. If visual rehabilitation is provided by the municipality in which the patient lives, the patient will be referred to such. Eye examination including autoperimetry, vision teacher assessment and VFQ-25 is repeated after 6 months. All patients will be registered in the national stroke registry, and the following variables will be analysed: Demographic variables, lifestyle factors, clinical status at admission (scores on NIHSS), clinical status at discharge and 3 months post-stroke (scores on modified Rankin Scale). So far 62 patients have been included. Limited research exists on visual impairment after cerebral infarction. It is important to establish the natural course of visual impairment after ischemic stroke, and to evaluate the effect of visual rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Written consent obtained,
* age \>18,
* acute occipital infarction on brain imaging and ability to cooperate for examination with autoperimetry

Exclusion Criteria:

* Pathological processes that severely affect eyesight.
Comparison of Ultrasound Guided Erector Spinae Plane Block and Ultrasound Guided Pericapsular Nerve Group Block for Pediatric Hip Surgery

Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia. The reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization. Regional anesthetic techniques seem to be a better choice for improving acute pain management in these patients, with fewer adverse effects.

Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia. The reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization.

Regional anesthetic techniques seem to be a better choice for improving acute pain management in these patients, with fewer adverse effects. The erector spinae block is a recently described ultrasound-guided technique in which local anesthetics is injected into a fascial plane between the tips of the thoracic transverse processes and the overlying erector spinae muscle (longissimus thoracis).

Pericapsular nerve group (PENG) block has been recently recommended by Girón-Arango et al. for use as postoperative analgesia in hip surgeries. It is a new regional anesthesia technique in the region between the anterior inferior iliac spine (AIIS) and ilio-pubic eminence (IPE).

The anterior capsule is the most richly innervated section of the joint suggesting these nerves should be the main targets for hip analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Children of both genders
* American Society of Anaestheologists (ASA) physical activity I, II
* aged more than one year
* admitted for elective pediatric hip surgery

Exclusion Criteria:

* Children with severe systemic disease with American Society of Anaestheologists (ASA) III or IV,
* children with previous neurological or spinal disorders,
* coagulation disorder,
* infection at the block injection site,
* history of allergy to local anesthetics
* bilateral hip surgery.
Phone Call in Type 2 Diabetes Patient

To assay the influence of personality profile to promote behavior change adherence for physical activity using a pedometer. The investigators also studied the metabolic profile, diagnosis of depression, intention to change behavior, physical activity referred and the quality of life. Casuistic and Methods: a randomized "quasi-experimental" enrolling 48 T2DM patients using a pedometer for 6 weeks. The intervention group received phone calls stimulating them to increase their walking activity. The control group received only one telephone call to explain pedometer use. The investigators also analyzed the personality profile, quality of life, and metabolic and anthropometric indexes.


Eligibility Criteria:
Inclusion Criteria:

* to assign written informed consent
* to have a phone call number
* to agree to use a pedometer for 6 weeks to be able to write the data concerning their number of steps per day

Exclusion Criteria:

* don´t agree to assign written informed consent
* don´t have phone number
* don´t have conditions to answer all the questionnaire
* don´t agree to use pedometer for 6 weeks
Comparison of the Efficacy of Shock Wave Therapy and Laser Therapy for Plantar Fasciitis

The aim of this study was to investigate the effects of extracorporeal shock wave therapy and low-intensity laser therapy on pain, functionality, plantar fascia thickness and balance in patients with plantar fasciitis.

Plantar fasciitis is a pathology resulting from inflammation and/or degeneration of the plantar fascia of the sole of the foot. It affects about 10% of the population. It is one of the most common causes of chronic heel pain in the community and there is tenderness to palpation on the medial aspect of the heel bone. Patients complain of pain particularly with the first step in the morning and after rest. Mechanical overload and overuse can cause inflammation of the fascia. Diagnosis is usually made by clinical assessment and no further investigations are required.

In this study, 90 patients between the ages of 18 and 65 who meet the inclusion and exclusion criteria will be enrolled and participants will be randomised into 3 groups. The 1st group will be taught ESWT and home exercises for 1 session per week for 3 weeks and will be asked to do it every day. The 2nd group will receive 3 sessions of low intensity LASER per week for 3 weeks and will be asked to do home exercises every day. The 3rd group will only be taught home exercises and asked to do participants every day for 3 weeks. Visual analogue scale, foot function index, plantar fascia thickness measurement with USG and balance parameters will be measured at the beginning of the study, at the end of the treatment and at week 12.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 18 and 65 years of age, diagnosed with "plantar fasciitis" by anamnesis and physical examination
* Complaint duration of at least 3 months
* Patients who agree to participate in the study

Exclusion Criteria:

* Complaint lasting less than 3 months
* Injection in the heel area in the last 6 months
* Use of physiotherapy modalities for the heel in the last 6 months
* Bilateral complaint
* Pregnancy
* Malignancy
* Epilepsy
* History of cardiac pacemaker
* Anticoagulant use
* History of systemic inflammatory disease
* History of lower extremity fracture or surgery
* Existing open wound in the heel area
* Patient hypersensitivity
* Systemic infection in the patient
* Uncontrolled hypertension in the patient
* Patient inability to cooperate
* History of neuromuscular disease affecting balance parameters
* Unwillingness of the patient to participate in the study