cyrilzakka/clinical-trials huggingface dataset:
Choline Nutritional Status Of Children With Cystic Fibrosis X-Sectional Study

Cystic fibrosis (CF) is the most common lethal, inherited disorder among Caucasians. Choline is an essential vitamin and as a methyl donor is critically needed to support the normal metabolism. Our previous studies have demonstrated that children with CF have depleted levels of choline. The purpose of this study is to gather data on the status of choline and related metabolites in children with Cystic Fibrosis by age and gender. The hypothesis for this study is that in children with CF, deficiency of choline and related metabolites will increase with increasing age.

The objective of this clinical project is to determine the status of choline and related metabolites in a large group of children with Cystic Fibrosis (CF). Based on the results it will be possible to determine which children are deficient or at risk for choline deficiency, and might benefit most from supplementation to sustain improvement in the plasma choline, and its metabolites. This will be a cross-sectional study that will, over a 6 month period, look to enroll as many patients as possible from 140 children with CF who are seen regularly at the CF Clinic at B.C.'s Children's Hospital. The study will involve the collection of blood and urine at the time of a scheduled appointment. All procedures for enrollment, collection of chart data and blood samples will follow procedures used in our previous studies. Body weight and height will be measured and routine blood work including liver enzymes, hematology, serum zinc, selenium and vitamins A and E will be completed as part of the clinic appointment. CF genotype, gender, birth date, hematology, clinical chemistry, anthropometric and nutritional measures, liver ultrasound, biopsy reports where available, pancreatic function (elastase, chymotrypsin/secretin-CCK) and all medications including mineral, vitamin and nutritional and enzyme supplements will be recorded from chart data. Blood samples will be used for analyses of choline and its metabolites and various biomarkers in redox pathways. A urine sample will be collected and used to assay excretion of related metabolites. Creatine will be analyzed to avoid the need for quantitative 24 hour urine collection.

Eligibility Criteria:
Inclusion Criteria:

* children with proven CF and known genotype.
* age 0-17 yr.
* outpatients of the CF Clinic at the British Columbia (B.C.) Children's Hospital.
* Children without CF or any other known disease.

Exclusion Criteria:

* children with CF receiving parenteral nutrition during the previous week.
* children who are hospitalized.
* children with any health problems other than CF that might in the opinion of the investigators influence dietary choices, growth, choline or methyl metabolites.
Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

A Prospective Randomized, Multi-center study to assess the Safety and Efficacy of Mucosta (Rebamipide), in combination with Omeprazole as adjuvant therapy in Gastric Ulcer Patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with dyspepsia or epigastric pain and endoscopically proven gastric and duodenal ulcers
* Required laboratory parameters and time limits (screening blood tests will be taken including hemoglobin, white blood cell count, random glucose, potassium, sodium, chlorine, creatinine, AST, ALT, bilirubin, and alkaline phosphatase)
* Age \> 18 years
* A statement that all patients must have signed an informed consent form prior to registration in study

Exclusion Criteria:

* Patients who had undergone surgery for ulcers
* History of hypersensitivity to drugs to be used in the study
* Women who are pregnant or lactating or intended to get pregnant during the study period
Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia

The purpose of this study is to compare the effect of lanthanum carbonate and calcium carbonate on the progression of coronary calcification and vascular endothelial dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Hyperphosphatemia (For patients without calcium carbonate, ≥4.5 mg/dL) (For patients with calcium carbonate, ≥4.0 mg/dL)
* With written informed consent

Exclusion Criteria:

* History of cardiac surgery
* With coronary artery stent
* Polycystic kidney disease
* Hypothyroidism
* On treatment with lanthanum carbonate
* History of admission within 3 months
* History of ileus
* Severe liver dysfunction
* Severe gastrointestinal dysfunction
* Allergy to lanthanum carbonate or calcium carbonate
* Pregnant or breastfeeding women
* Judged as ineligible by the investigator
Comparison of Local Anesthetic Infiltration and Different Fascial Plane Blocks in Inguinal Hernia Repair

In this study, quadratus lumborum block (QLB), transversus abdominis plane (TAP) block, and local anesthetic infiltration will be performed preoperatively in patients who will undergo unilateral inguinal herniorrhaphy operation under general anesthesia. Quality of recovery (QoR-15) score, postoperative acute and chronic pain levels will be evaluated.

Inguinal hernia repair, one of the most common operations, causes moderate to severe postoperative pain. The postoperative pain delays patients' recovery and return to daily life, increases the rate of readmission to the hospital, and can lead to persistent postoperative pain.Procedure-specific postoperative pain management (PROSPECT) recommendations for optimal pain management have been recently updated. Accordingly, in addition to preoperative or intraoperative paracetamol and nonsteroidal anti-inflammatory analgesics, local anesthetic infiltration and/or regional analgesia techniques (ilio-inguinal nerve blocks or TAP block) with rescue opioids are recommended. Also, it has been reported that further research is needed on new regional techniques (other fascial plane blocks etc).It has been shown that QLB potentially results in extensive sensory blockade (T7-12), and in cadaver studies, the iliohypogastric and ilioinguinal nerves are constantly involved. In addition, there are studies suggesting that it provides much longer analgesia than TAP block. There are few studies on its efficacy in inguinal hernia repair that are in pediatric cases or performed in addition to central blocks. It is hypothesized that QLB may provide better and longer analgesia, may increase the quality of recovery and reduce the development of resistant chronic pain, compared to other regional methods such as local infiltration or TAP block, that proven effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo elective unilateral inguinal herniorrhaphy under general anesthesia
* American Society of Anesthesiology (ASA) physical classification I-III

Exclusion Criteria:

* Patients who will undergo laparoscopic surgery
* Previous inguinal hernia repair surgery
* A history of opioid use or pain management
* Coagulopathy or anticoagulant use
* Patients who have difficulty communicating or who are not cooperative
Evaluation of Isostretching Effects in Patients With Mechanical and Postural Chronic Low Back Pain

Isostretching is effective in treating chronic back pain to improve pain, quality of life and functional capacity.

Objective: This study investigated the influence of isostretching on patients with chronic low back pain. Methods: It was a randomized, controlled trial with concealed allocation, intention-to-treat analysis, and blind assessment. Fifty-four patients with chronic low back pain were randomized to an experimental group and a control group. The experimental group performed isostretching twice a week for 45 days, while the control group remained on the waiting list for physical therapy. Patients were submitted to evaluations at baseline, after 20 and 45 days of treatment with regard to pain, quality of life, functional capacity, and satisfaction. Results: The experimental group exhibited statistically significant improvements in comparison to the control group with regard to pain (p = .003), functional capacity (p = .026), patient satisfaction (p \< .001), and quality of life as determined by the functional capacity (p = .012), physical aspects (p = .011) and pain (p = .006) subscales of the SF-36. The experimental group used a significantly lesser amount of pain medication than the control group (p = .03). Conclusion: Isostretching was effective in reducing pain and in improving function, patient satisfaction and some aspects of quality of life in patients with chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with chronic low back pain with pain located between the last rib and the gluteal fold over 12 weeks;
* Mechanical back pain that worsens with exertion and relieved by rest;
* Pain between 3 and 8 cm measured by analog pain scale.

Exclusion Criteria:

* Subjects who presented pain root
* Fibromyalgia
* Severe scoliosis with abnormal alignment of the spine (Cobb angle\> 40); Tumors in the column; Infiltration in the lumbar spine in the last three months; Previous surgery of the spine (patients return to work or process expulsion)
* Have changed or initiated physical activity in the last three months
* Body mass index greater than 30 kg/m2
HDDO-1614 Bio Equivalence Study

A randomized, open-label, single-dose, crossover study

This clinical trial is conducted with a randomized, open-label, single-dose, and cross over study designs. Investigators will compare the pharmacokinetic parameters of test drug(single oral dose, single administration) with pharmacokinetic parameters of comparator 1 and 2(combined administration, single oral dose).

Eligibility Criteria:
Inclusion Criteria:

* Body weight 50kg ≤ / BMI=18\~29kg/㎡
* A person who is determined to be eligible for the test through a physical examination or an interview
* Those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, and serology test

Exclusion Criteria:

* Patients with clinically significant liver, pancreas, kidney, nervous system, respiratory, endocrine, hematologic, mental, cardiovascular
* Patients with a history of gastrointestinal disorders or history of gastrointestinal surgery that may affect the absorption of pharmaceuticals for clinical trials
* Any person who shows any of the following results in the screening test

  1. AST or ALT \> 2 times upper limit of normal range
  2. Total Bilirubin \> 2.0mg/dL
  3. Glomerular filtration Rate(eGFR) \< 60mL/min/1.7㎡
* Those who show signs of hypotension (systolic blood pressure ≤ 100mm Hg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
* Those who have a history of drug or who have a positive urine drug test
An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors

The purpose of the dose escalation part of this study is to determine the feasibility of using the combination of copanlisib and nivolumab in subjects with advanced solid tumors, and to determine the maximum tolerated dose of copanlisib in combination with nivolumab. The maximum tolerated dose will then be used in Phase 2 (dose expansion) of the study.

Study was originally designed with both Phase I and Phase II part, but sponsor decided not to conduct Phase 2 part due to strategic portfolio re-prioritization.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a histologically confirmed diagnosis of:

Phase 1b:

* Advanced solid tumors where nivolumab is indicated as per the latest nivolumab Prescribing Information,

Phase 2:

* Metastatic NSCLC, progressing on or after prior pembrolizumab therapy with or without chemotherapy, irrespective of PD-L1 expression Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations.
* Recurrent or metastatic HNSCC progressing on or after prior pembrolizumab therapy with or without chemotherapy
* HCC progressing after any prior therapy.

Exclusion Criteria:

* Active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* Major surgery, open biopsy or significant traumatic injury ≤ 28 days prior to first administration of study intervention. Central line surgery is not considered major surgery
* Symptomatic metastatic brain or meningeal carcinomatosis or tumors unless the participant is \> 6 months from definitive therapy (surgery or radiotherapy), has no evidence of tumor growth on an imaging study and is clinically stable with respect to the tumor at the start of study intervention.
* Other malignancy within the last 5 years except for the following, which are permitted:

  * curatively treated basal cell/squamous cell skin cancer,
  * carcinoma in situ of the cervix,
  * superficial transitional cell bladder carcinoma (if BCG \[Bacillus Calmette-Guerin\] treatment was given, there should be a minimum of 6 months between last dose and enrollment),
  * in situ ductal carcinoma of the breast after complete resection,
  * participants with localized, resected and/or low-risk prostate cancer may be eligible after discussion with the sponsor's designated medical representative and sponsor's approval.
* Other protocol inclusion/exclusion criteria may apply
Efficacy and Safety of 400 μg Twice Daily of Aclidinium Bromide vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of stable moderate to severe COPD as defined by GOLD (the Global Initiative for Chronic Obstructive Lung Disease) guidelines(http://www.goldcopd.org); a postbronchodilator FEV1/forced vital capacity \[FVC\] ratio \< 70% and FEV1 ≥ 30% to \<80% of the predicted value.
* Current or former cigarette smokers with a smoking history of at least 10 pack-years.

Exclusion Criteria:

* History or current diagnosis of asthma
* Patients who have been hospitalized for an acute COPD exacerbation within 3 months prior to Visit 1
* Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1.
* Patients with any clinically significant respiratory conditions other than COPD
Combined Epidural Morphine and Midazolam on Postoperative Pain

this study aim to Compare the effect of preoperative Epidural Midazolam, Morphine and their combination in postoperative pain relief and total morphine consumption.

Major abdominal surgeries with abdominal incisions lead to severe abdominal pain, which if treated inadequately, can cause shallow breathing, atelectasis, retention of secretions and lack of cooperation in physiotherapy. This increases the incidence of post-operative morbidity and leads to delayed recovery.Epidural anesthesia is safe and inexpensive technique with the advantage of providing surgical anesthesia and prolonged postoperative pain relief. It also an effective treatment of operative pain blunts autonomic, somatic and endocrine responses. Morphine and midazolam can be used as adjuvant to bupivicain to reduced the postoperative pain

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients scheduled for major abdominal cancer surgeries

Exclusion Criteria:

* patients with known allergy to the study drugs,
* significant cardiac, respiratory, renal or hepatic disease,
* drug or alcohol abuse,
* psychiatric illness that would interfere with perception and assessment of pain.
Regorafenib Alone or in Combined With Transcatheter Arterial ChEmoembolization in Treatment of Advanced Hepatocellular Carcinoma After First Line Targeted Therapy

. 1 Clarify the difference in efficacy of regofinib combined with TACE compared with second-line treatment of advanced liver cancer; 2. To evaluate the safety and prognostic imaging factors of regorofenib in advanced second-line therapy; 3, to explore whether it is necessary to increase the treatment of TACE in the second-line treatment of advanced HCC.


Eligibility Criteria:
Inclusion Criteria:

( - ) After pathological / clinical diagnosis of hepatocellular carcinoma or radical resection of hepatocellular carcinoma; ( - ) CNLC Ⅲa Patients with intrahepatic recurrence before (including a); ( - ) Previous failure of first-line systemic treatment; ( - ) Age: 18-75 years old; ( - ) Child-Pugh 7 points; ( - ) ECOG PS Grade 0-2; ( - ) At least one measurable lesion in the liver.

Exclusion Criteria:

( - ) Known hepatobiliary tubular cell carcinoma and mixed cell carcinoma and fibrolamellar cell carcinoma; ( - ) Previous (within 5 years) or concurrent other incurable malignant tumors; ( - ) Having received local treatment, systemic chemotherapy, radiotherapy other than TACE during the first-line systemic treatment; ( - ) During the second-line systemic treatment, I also received local treatment, systemic chemotherapy, radiotherapy other than TACE; ( - ) Serious uncontrollable systemic and other systemic diseases, such as uremia, cardiovascular and cerebrovascular accidents; ( - ) Allergy to any drug included in the study; ( - ) Pregnant or lactating women;
Evaluation of a Community Health Program for the Prevention of Type 2 Diabetes and Other Cardio-metabolic Risk Factors in Adults: Districts of Barranquilla and Bogota, Colombia - January 2017 - December 2019

The main aim of this study is to evaluate the feasibility and effectiveness of a program for modifying lifestyles for diabetes prevention type 2 and control cardio-metabolic risk factors in adults with different categories of risk from the primary health care strategy.

The project will show the effect of these interventions for the first time in people With different risk of developing type 2 diabetes throughout the life in populations living in Colombia Located in 2 different cities, one of them in the interior of the country (districts of Bogota) and another in the north coast (districts of Barranquilla) .

Cardiovascular disease (CVD) and type 2 diabetes (T2D) are currently the public health problems fastest growing globally. According to the International Diabetes Federation (IDF) is estimated to have diabetes approximately 382 million people in the world. It is shown that early interventions in lifestyle can reduce the burden of type 2 diabetes and factors of cardiovascular modifiable risk.

This is an intervention study in cluster. 36-month integrated into 4 phases:

1. Design and adaptation of educational intervention
2. Population Screening
3. Stepwise intervention program
4. Evaluation results.

For population screening test FINDRISC validated for the Latin American population will be employed and a score of 12 will be considered as a cutoff to all who have a score equal to or greater than 12 (moderate or high risk) they perform a test oral glucose tolerance (OGTT) according to the results 3 groups will be established

* High risk group: Subjects with FINDRISC score ≥12 and impaired glucose tolerance (IGT)
* Moderate risk group: Subjects with FINDRISC score ≥12 and impaired fasting glucose or norm tolerant
* Low risk group: Subjects with FINDRISC score \<12.

Intervention program: One year of duration, 3 types of programs are established.

* Lifestyle Intervention program_ Communitarian: Intervention program at Community level with Low risk group.
* Lifestyle Intervention program_ Informative: Program information intervention for the group with moderate risk.
* Lifestyle Intervention program_ structured: intervention program for members of high-risk group.

An evaluation of the different variables are studied at baseline and the final of the intervention in the three groups established.

Eligibility Criteria:
Inclusion Criteria:

* People over age 30 years, residents within the perimeter of the conglomerate in the districts of Barranquilla and Bogota
* Wishing to participate and sign informed consent

Exclusion Criteria:

* DT2 known and / or treated
* History of diseases or events that prevent their participation
* Neurological disability that does not allow you to make own decisions
* Pregnant women
Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection

The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin (preferably prior to surgical incision) to prevent post-cesarean infection.

Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.


Eligibility Criteria:
Inclusion Criteria:

-

Pregnant Women aged 14 years and over at ≥ 24 weeks' viable gestation who will undergo unscheduled/non-elective cesareans with either:

1. Labor (spontaneous or induced): active labor (ongoing contractions and at least 4cm dilated or contractions for at least 4 hours with documented cervical change of ≥1cm dilatation or ≥50% effacement), or
2. Membrane rupture (standardized to duration of at least 4 hours prior to randomization).

Exclusion Criteria:

* Patient unwilling or unable to provide consent
* Multiple pregnancy
* Known azithromycin (or other macrolide) allergy
* Vaginal delivery
* Elective or scheduled cesarean prior to labor or membrane rupture.
* Azithromycin, erythromycin or other macrolide antibiotic use within 7 days of enrollment.
* Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization.
* Patient is unable or unlikely to follow-up after delivery (e.g. no prenatal care or a non-resident patient)
* Fetal demise or major congenital anomaly
* Significant liver disease defined as known cirrhosis or elevated transaminases of at least 3-fold upper limit of normal
* Significant renal disease defined as serum creatinine known to be \>2.0 mg/dl or on dialysis.
* Active congestive heart failure (EF\<45%) or pulmonary edema
* Active diarrhea at time of delivery
* Any patient with significant electrolyte abnormalities such as hypokalemia or hypocalcemia
* Any patient with structural heart disease or arrhythmias, or taking any medications known to prolong the QT interval
* Patient currently being treated with efavirenz, nelfinavir or fluconazole