cyrilzakka/clinical-trials huggingface dataset:
Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected People in Wenxi County, Shanxi Province, China

The purpose of this study is to determine the safety, effectiveness, and tolerability of the anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV infected people in Wenxi County, Shanxi Province, China.

HIV infection in China has reached epidemic proportions, especially in poor rural communities. Among the infected are former commercial plasma donors who became infected through contaminated blood collection equipment. This study will evaluate the safety, efficacy, and tolerability of an antiretroviral (ARV) regimen given to treatment-naive HIV infected adults. Participants will be recruited in Wenxi County, Shanxi Province.

This study will last 1 year. At study entry, all study participants will be given an ARV regimen consisting of lamivudine/zidovudine twice daily and efavirenz once daily. There will be 11 study visits; a physical exam, blood collection, and vital signs measurement will occur at all study visits. Participants will also receive safe sex and adherence counseling at all visits. Participants will be asked to complete an adherence questionnaire and will have their pills counted at most visits.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* Antiretroviral naive
* CD4 count of less than 350 cells/mm3 within 30 days of study entry
* Willing to use acceptable forms of contraception
* Willing to stay in the study area for the duration of the study
* Willing to not consume traditional Chinese medicines for the duration of the study
* Willing to adhere to the follow-up study schedule

Exclusion Criteria:

* Presence of an acute serious medical illness within 14 days prior to study entry. Participants with recently diagnosed opportunistic infections (except tuberculosis \[TB\]) and are stable on therapy for more than 30 days are eligible.
* Current pancreatitis
* Require certain medications
* Pregnant or breastfeeding
Virtual Care In Pediatric Asthma

The purpose of this study was to determine the impact of virtual care for children with asthma on the disease management and quality of life of children with asthma.

After children were randomized by protocol number, they completed the child information form, the quality of life scale of the child with asthma, and the asthma control test at the first interview. PEF meter and asthma diary were given at the first interview. Children in the virtual care group received online training in four modules within the first month.The virtual group provided counseling services by phone and video conference for six months. The control group received the standard care provided in the clinic. Asthma diary data were collected from both groups at the end of each month

Eligibility Criteria:
Inclusion Criteria:

* having a smartphone or tablet with internet connection, parents and patient willing to maintain a daily log of symptoms and medication use

Exclusion Criteria:

* Children who had mental problems, had not attended at least one of the training and did not send at least one month of their asthma diary were excluded from the study.
Exisulind Versus Placebo After Surgical Removal of the Prostate

This is a study in which patients with prostate cancer treated by surgical removal of the prostate and considered to be at risk for prostate cancer recurrence will receive Exisulind 250 mg twice a day or placebo twice a day for two years.


Eligibility Criteria:
Males 18 years of age or older with prostate cancer treated primarily by radical prostatectomy and randomized within 45 days after surgery may be eligible for enrollment into this protocol. Participants cannot have had hormonal therapy, cryotherapy, thermotherapy, or radiotherapy prior to entering the study.
Virtual Reality for Pain Management in Burn Patients

This study is a randomized proof-of-concept study to assess the efficacy of Virtual Reality (VR) vs standard of care in 50 adult patients in the New York Presbyterian Burn Unit. The participants who are randomized to receive the virtual reality intervention will also receive opioids, which is the standard of care and is known to be effective. Participants will be randomly assigned to two groups. The first group will receive VR during their painful procedure (e.g., wound dressing changes, physical therapy etc.) in addition to the standard of care. The other group will receive standard of care (and no VR).


Eligibility Criteria:
Inclusion Criteria:

* 8 years and older
* Patients with a burn injury and is in the Burn Unit at New York Presbyterian
* Awake, alert, ambulatory
* The burn comprises less than 15% total body surface area (TBSA)
* The patient does not require conscious sedation such as ketamine for staple removal or wound dressing changes
* The patient is able to give informed consent

Exclusion Criteria:

* Diagnosis of a cognitive disorder, psychotic disorder or bipolar I as determined by self-report from previous diagnosis
* Current opioid abuse
Medial Versus Lateral Approach in Ultrasound (US)-Guided Supraclavicular Block

The ultrasound guided supraclavicular block is a peripheral nerve block which is considered safe, has a fast onset, is dense and provides complete block of the nerves supplying the hand, forearm and arm. However retrospective studies done at Toronto Western Hospital have highlighted the fact that most commonly the ulnar nerve fibres (responsible for sensations in the ring finger, little finger and the corresponding part of hand), sometimes escape this block and need additional supplementary block at a distal peripheral nerve site. It is a confusing fact since all nerve fibres are compactly arranged in a sheath at the supraclavicular level. The local anaesthetic agent at this level should be equally distributed among all nerve fibres. The purpose of this study is to compare two different approaches (medial and lateral) adopted by our clinicians to perform this block and to test the effectiveness of each approach for successful ulnar nerve fibre blockade.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients presenting for upper limb surgery, excluding shoulder surgery
* Age 18-80 yrs
* BMI \< 35
* ASA I - III
* Consent for the study

Exclusion Criteria:

* Pre-existing sensory or motor neurodeficit.
* Sensitivity to local anaesthetic agents.
* Patients on anticoagulants or antiplatelet medications (Minidose Aspirin is acceptable) with abnormal coagulation profile.
* Compromised pulmonary reserve due to COPD, Kypho-scoliosis or Restricted lung disease.
* Infection or any obvious pathology at the site of block performance
* History of drug abuse.
* Psychiatric disease or any condition that precludes an informed consent.
Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child

The purpose of this biomedical research is to evaluate the feasibility of the treatment with the new spinal distraction device ASTS in patients aged 4 to 10 years with severe early onset scoliosis.

The hypothesis of this project is that the new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

The ASTS (for Active Scoliosis Treatment System) growing rod is a new fully implantable motorized spinal distraction device which can ensure a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

Despite a better understanding and technical progress, the evolutionary early scoliosis remains a therapeutic challenge. The definition includes idiopathic scoliosis beginning before the age of 3 years, congenital scoliosis, neuromuscular and syndromic. Spinal deformity is often progressive and may compromise cardiorespiratory function.

The goal of treatment is to prevent further avoiding spinal fusion in a subject in growth. Surgery is indicated in case of failure or cons-indication of conservative treatment (corset or plaster). The principle is to position the posterior rods subcutaneous or in muscle attached to two ends of the deformation.

Intraoperative distraction allows correction of the deformity. A new distraction is performed every 6 months until skeletal maturity.

Considerable complication rates are reported (58%), mainly implant infections and disassembly, because of the need for multiple reoperations. Motorized implants can potentially avoid repeated interventions limiting complications.

Thus, the central hypothesis of this project is a new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

Eligibility Criteria:
Inclusion Criteria:

* Patient 4 to 10 years
* Patient weight between 15kg at 50kg
* Introducing severe scoliosis (Cobb angle\> 40 °) with early onset
* Failed or cons-indication of conservative treatment (cast or brace)
* Agreement of parents or legal guardian (written agreement) and the patient (at least an oral agreement).

Exclusion Criteria:

* Contraindication to surgery
* Age less than 4 years or above 10 years
* Weight less 15kg and above 50 kg
Could Ephedrine Replace Dexmedetomidine Fordexmedetomidine Prevention of Shivering in Women Undergoing Cesarean Section Under Spinal Anaesthesia

Could ephedrine replace dexamedetomidine for prevention of shivering in women undergoing Cesarean section Under spinal anaesthesia

Shivering, rhythmic oscillatory movement of upper limbs, neck and jaw, is common during regional anesthesia with an incidence up to 56.7% of patients. Perioperative shivering is a commonly observed clinical problem well known to anesthesiologists caring for women undergoing a Cesarean delivery (CD). The median incidence of shivering in parturients having labour epidural analgesia or CD with epidural or spinal anesthesia has been estimated to be 52%.1 Severe shivering causes physiologic stress, interferes with patient monitors, and decreases the comfort and overall satisfaction of women during childbirth. Ephedrine well-known sympathomimetic agent, has been used to treat hypotension during regional anesthesia. It has antiemetic effect for short-term . Ephedrine maintained hemodynamics and minimized decrease of the core temperature when given by an intravenous infusion during spine surgery under general anesthesia . Dexmedetomidine, a selective a-2 agonist, was introduced in clinical practice in the United States in 1999. It is approved by Health Canada as a short-term sedative for mechanically ventilated adult patients in the intensive care unit and sedation of non-intubated patients prior to and/or during surgical procedures. It has since been approved and is widely used in pediatric populations and for procedural sedation of non-intubated patients.9 Nevertheless, the clinical use of dexmedetomidine has expanded to various off-label uses. In obstetrical anesthesia, it has been used as part of multi-modal intravenous labour and post-CD analgesia,10-13 as a neuraxial adjunct in the epidural space for labour,14 and intrathecally for shivering prevention during CD

Eligibility Criteria:
Inclusion Criteria:

* Adult female from 18 to 35 yrs
* uncomplicated pregnancy for elective cesarean delivery

Exclusion Criteria:

* patient refusal
* allergy to the drug
* contraindications of spinal anaesthesia
* patients with DM or thyroid disorders
Copeptin in Normal- to Hyperosmolar States

Kinetics of Copeptin in response to osmotic alterations in healthy volunteers

Construction of the standard area of copeptin release in the normo- and hyperosmolar state and its half-life based on ist decline during hypoosmotic Suppression in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Minimum Age 18
* no severe comorbidities
* no medication (except contraceptives)
* baseline sodium Level 135-145mmol/l
* euvolemic status

Exclusion Criteria:

* history of heart failure
* liver cirrhosis
* kidney disease (GFR \<60ml/min)
* anemia
* uncontrolled Hypertension
* pregnancy
* Diabetes mellitus
* BMI \>28kg/m2
* other severe disease
Extracorporeal CO2 Removal in Acute Exacerbation of COPD Not Responding to Non-Invasive Ventilation

Background: Acute exacerbation of chronic obstructive pulmonary disease (ae-COPD) has a gold standard treatment: non-invasive ventilation (NIV). However, this treatment sometime fails, and an invasive mechanical ventilation (IMV) is required. The extracorporeal CO₂ removal (ECCO₂R) device can be an alternative to intubation. The aim of the study is to evaluate ECCO₂R efficiency and safety and enlighten ECCO₂R benefit/risk compared to IMV.

Methods: Successive ae-COPD patients for whom NIV failed were retrospectively analyzed during two periods: before and after the ECCO₂R device implementation in our ICU in 2015. We considered the before period as standard of care and patients were treated with IMV. The ECCO₂R device was a pump-driven veno-venous system (Xenios AG).

The study compare 2 strategies for COPD patients not responding to non invasive ventilation: the gold standard which is mechanical ventilation and a new technique which is extracorporeal CO2 removal. This technique have been implemented in februrary 2015 in our intensive care unit so we choose to compare patients' outcome before and after the arriving of this device.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* no improvement or worsening of respiratory acidosis after more than one hour of non invasive ventilation treatment
* and non improvement of respiratory distress signs
* and pH \< 7,35 and PaCO2 \> 45 mmHg

Exclusion Criteria:

* patients not eligible for endotracheal intubation because of ethical limitations
Sodium Status in Septic Patients and Its Relation to Prognosis an Hospital Stay

The aim of the present study is to identify the prevalence and prognostic impact of sodium imbalance on sepsis and septic shock patients

Sepsis and septic shock are among the most prevalent causes of intensive care unit (ICU) admissions. They account for around 10-50% of the mortality rate, which remains high despite extensive research of the Surviving Sepsis Campaign, and national core measures Sepsis is defined as "Organ dysfunction that threatens the patient's life caused by the impaired host response to infection" septic shock is defined as hypotension and serum lactate level greater than two mmol/L, as well as not responding to adequate fluid resuscitation requiring the use of vasopressors to maintain the mean blood pressure of 65 mm Hg or higher . Sepsis and septic shock are considered medical emergencies .

Acute hypernatremia is considered one of the features of homeostasis disturbances, which is common in septic patients with an incidence reaching up to 47% Finding biomarkers which predict the outcome of sepsis is challenging . Since electrolyte imbalance, specifically hypernatremia, is one of the commonest problems associated with sepsis and septic shock patients \[20, 21\]. It is, therefore, of current interest to study the evolution of sepsis in patients who have been shown to have hypernatremia.

Recent evidence shows that serum sodium levels may not be completely explained by fluid balance or sodium intake . Some studies suggest that sodium is intimately tied to the immune system, thus raising the question of whether inflammatory states such as sepsis can play a role in the development of hypernatremia

Eligibility Criteria:
Inclusion Criteria:

The diagnosis of sepsis and septic shock was made prior to the ICU admission. Sepsis and septic shock were defined according to the 3 definition using the Quick Sofa score of 2 or more

Sepsis : 2 or more of the SIRS criteria :

* Temperature \>38 or \<36 c
* Heart Rate \>90 beats/minute
* Respiratory rate \>20 cycle /minute
* wbc \>20,000 or \< 4,000 Plus the presumed existence of infection
* Blood pressure can be normal Septic shock : the same as sepsis plus refractory hypotension
* After bolus of 20- 40 ml/kg patient has one of the following :

  * SBP \>90 mm Hg
  * MAP \<65 mm Hg
  * Decrease of 40 mm Hg of base line hypernatremia \[Na+\]\> 145 mmol/L eunatremia \[135-145\]mmol/l hyponatremia \<135 mmol/L

Exclusion Criteria:

patients under the age of 18 years patients with a previous diagnosis of hyperaldosteronism patints diagnosed with Cushing syndrome, patients diagnosed with diabetes insipidus.
Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility

Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. The goal of this feasibility study is to use a breathalyzer and cost-controlling deposit contracts to facilitate a contingency-management intervention to reduce alcohol use that requires no in-person contact between the participants and the study staff during the intervention phase.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Provide written informed consent
* Meet Diagnostic and Statistical Manual criteria for alcohol use disorder
* Express a desire to cut down or quit drinking
* Be willing to pay a $75 deposit toward their incentive fund

Exclusion Criteria:

* Pregnant or lactating
* Meet Diagnostic and Statistical Manual criteria for other substance use disorder (except caffeine or nicotine)
* Score 23 or greater on the Alcohol Withdrawal Symptom Checklist
* Have immediate plans to move out of the area
Antimicrobial Resistance Rate In Escherichia Coli And Klebsiella Pneumonia : A Retrospective Study

Antibiotics are medicines used to avoid and treat bacterial infections. Antibiotic resistance is increasing to dangerous level globally.

Antibiotics resistance is a global health problem.

Eligibility Criteria:
Inclusion Criteria:

1. patients with UTI
2. patients with dysuria
3. patients with loin pain

Exclusion Criteria:

1. patients with surgery
2. patients with cancer
The Effect of Lactobacillus Cultures on Iron Bioavailability.

The purpose of this study is to determine the effect of a lactic acid fermented oat gruel on iron absorption in the upper and lower part of the intestine, respectively.

Iron deficiency and low iron stores are prevalent in infants, adolescents, and women of childbearing age in both Western and developing countries. One cause of iron deficiency is the low iron bioavailability from foods, which is partly due to inhibiting factors in the diet, such as phytate and phenolic compounds. A number of single meal studies with lactic acid fermented vegetables and cereals have shown a significant increase in iron absorption in humans. This is believed to be caused mainly by the lactic acid produced during the fermentation process, which conteracts the inhibiting effect of phytate.

A recent study of ours indicate that the increased nonheme iron absorption from a low iron bioavailability meal was due not only to an effect of the lactic acid produced, but also a specific effect of the lactic acid bacteria. As lactic acid bacteria colonizes the entire intestine but mainly the colon it is of interest to determine whether these bacteria can increase iron absorption from the distal part of the intestine since iron absorption normally is believed to be absorbed from the duodenum and most proximal small intestine.

The purpose of this study is therefore to determine the the effect of Lactobacillus plantarum 299v in a lactic acid fermented oat gruel on iron absorption in the proximal and distal small intestine, respectively, in a cross-over design with 18 healthy women of childbearing age, served both fermented oat gruel and pasteurized, fermented oat gruel.

Eligibility Criteria:
Inclusion Criteria:

* serum ferritin in the range 12-30 µg/L
* hemoglobin \> 110 g/L

Exclusion Criteria:

* pregnant or lactating
* smoker
* intake of vitamin-, mineral- or other dietary supplements during the study and 2 mo before start
* sports practicing \>10h/week
* blood donation during the study and 2 mo before start
* medication
* participation in other isotope studies
Direct Endovascular Treatment Versus Bridging Treatment In Basilar Artery Occlusive Stroke

Two recent randomized controlled trials (BAOCHE and ATTENTION) have confirmed the efficacy and safety of endovascular therapy in patient with acute ischemic stroke (AIS) due to basilar artery occlusion (BAO). However, it is still inconclusive whether there is any differences between endovascular therapy with or without bridging intravenous thrombolysis in acute BAO. So far, no randomized controlled trial has been conducted specifically for endovascular therapy with or without intravenous thrombolysis for ischemic stroke due to BAO. Therefore, this study plans to conduct a prospective, multicenter, randomized controlled trial to compare the functional outcomes between endovascular therapy with and without intravenous thrombolysis in patient with AIS due to BAO.

This study is a multicenter, parallel, open label, randomized controlled trial comparing direct endovascular therapy versus endovascular therapy bridging intravenous thrombolysis (IVT). This study intends to include patients with AIS due to BAO fulfilling the following inclusion criteria: patients with AIS caused by BAO confirmed by CTA/MRA/DSA; IVT can be started within 4.5 hours after symptoms onset; Age ≥ 18 years old; NIHSS score ≥ 6.

The main outcome is the 3-month mRS scale score. Secondary outcomes included NIHSS at 24 hours and 7 days after surgery, CTA vascular recanalization at 24-72 hours, mRS at 5-7 days, and infarct volume. The safety outcomes included 90-day mortality and the incidence of sICH.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of acute ischemic stroke (AIS);
* Caused by basilar artery occlusion (BAO) confirmed by CTA, MRA, or DSA;
* CT or MRI ruling out intracranial hemorrhage;
* Eligible for intravenous thrombolysis (IVT) and endovascular treatment (EVT) (within 4.5 hours after symptom onset);
* A score of at least 6 on the NIHSS score;
* Age of 18 years or older;
* Written informed consent.

Exclusion Criteria:

* Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS \>2
* Any contra-indication for intravenous thrombolysis (IVT), according to guidelines of the American Heart Association, i.e.:

  * Arterial blood pressure exceeding 185/110 mmHg
  * Blood glucose less than 2.7 or over 22.2 mmol/L
  * Cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuro-imaging
  * Serious head trauma in the previous 3 months
  * Major surgery or serious trauma in the previous 2 weeks
  * Gastrointestinal or urinary tract hemorrhage in the previous 3 weeks
  * Previous intracerebral hemorrhage
  * Use of anticoagulant with INR exceeding 1.7
  * Known thrombocyte count less than 100 x 10\^9/L
  * Treatment with direct thrombin or factor X inhibitors
  * Treatment with heparin (APTT exceeds the upper limit of normal value) in the previous 48 hours.