cyrilzakka/clinical-trials huggingface dataset:
Impact of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older

The primary objective of this study is to evaluate the impact of the implementation of collaborative pharmaceutical care on drug support at admission for patients 65 years of age and older.

This is a cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. A randomly selected center is crossed-over into the intervention every fifteen days after the start of inclusions.

The secondary objectives are to evaluate:

A. The potential and observed clinical impact of the implementation of collaborative pharmaceutical care.

B. The acceptance rate of pharmaceutical interventions during collaborative pharmaceutical care.

C. Avoidable costs related to the consumption of care generated by the occurrence of serious adverse drug reactions.

D. The satisfaction of health professionals concerning the transfer of information on the patient's drug therapy carried out as part of collaborative pharmaceutical care.

Eligibility Criteria:
Inclusion Criteria:

* The patient or his/her legal representative was informed about the study
* The patient is admitted as an in-patient to one of the participating hospitals
* The patient is available for 3 months of follow-up

Exclusion Criteria:

* The subject is participating in another drug study
* The subject is under judicial protection
* It is impossible to correctly inform the patient or his/her legal representative
* The patient or his/her legal representative refuses to participate in the study
* The expected life span of the patient is less than the required 3 months of follow-up
* It is impossible to contact the patient after hospitalisation
* Hospitalizatin for longer than 21 days
Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer

The purpose of this study is to determine the maximum tolerated dose of Lapatinib with Carboplatin AUC 6 in patients with platinum sensitive recurrent ovarian or primary peritoneal carcinoma and to determine the nature and degree of toxicity of Lapatinib in combination with carboplatin AUC 6 in this cohort of patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of epithelial ovarian or primary peritoneal cancer
* Measurable disease or evaluable disease with CA125 \>100
* One prior treatment with taxane/platinum based chemotherapy, but patients with recurrent ovarian cancer not receiving platinum-based chemotherapy at time of initial diagnosis will be allowed
* Recurrence after treatment free interval of at least 6 mos from completion of primary chemotherapy
* 19 years of age or older
* Life expectancy of greater than 12 weeks
* Performance status of 0, 1 or 2 (based on GOG Performance Status)
* Normal bone marrow, renal and hepatic function based upon lab tests
* Cardiac ejection fraction within institutional normal range
* Ability to swallow and retain oral medication
* Ability to understand a written informed consent document

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering study
* Epithelial ovarian tumors of low malignant potential, stromal or germ cell origin
* Non-measurable or non-evaluable disease
* Archived tumor tissue not available for assay
* Patients may not be receiving any other investigational agents or concurrent anticancer therapy, or herbal (alternative) medicines
* Patients with known brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
* Uncontrolled inter-current illness
* Patients who are pregnant
* HIV-positive patients receiving combination anti-retroviral therapy
* Patients with GI tract disease resulting in an inability to take oral medication
Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"

The purpose of this study is to evaluate the safety and efficacy on participants receiving first-line eradication and second-line eradication including vonoprazan (Takecab) tablets (triple therapy) in the routine clinical setting.

The drug being tested in this study is called Vonoprazan (Takecab). Vonoprazan is being tested to treat people who have gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or H. pylori gastritis. This study will look at the presence or absence of new concerns regarding the safety of triple therapy with Vonoprazan tablets, amoxicillin, and clarithromycin (first-line eradication) and triple therapy with Vonoprazan tablets, amoxicillin, and metronidazole (second-line eradication) for supplemental Helicobacter pylori (H. pylori) eradication in the routine clinical setting. The study will enroll approximately 500 patients.

First-line eradication

* Vonoprazan 20 mg / Proton pump inhibitor
* Amoxicillin hydrate 750 mg
* Clarithromycin 200 mg

If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful.

Second-line eradication

* Vonoprazan 20 mg
* Amoxicillin hydrate 750 mg
* metronidazole 250 mg

This multi-center trial will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

* Participants receiving H. pylori eradication treatment for the first time
* Participants for whom H. pylori eradication with Takecab tablets or proton pump inhibitor + amoxicillin + clarithromycin was found unsuccessful and who will receive eradication treatment with amoxicillin and metronidazole

Exclusion Criteria:

* Participants with previous history of hypersensitivity to ingredients in Takecab tablets
* Participants taking atazanavir sulfate or rilpivirine hydrochloride
Heart Rate Variability (HRV) to Evaluate Surgical Risk on Patients on Beta Blockers

Beta blockers have been shown to decrease the risk of intraoperative cardiac events in patients at high cardiac risk. However, they have also been associated with side effects (for instance, stroke.) The role of beta blockers in patients at intermediate cardiac risk undergoing surgery is controversial. Heart rate variability is a way of evaluating the cardiac function of a patient. Decreased heart rate variability is associated with early cardiac death in patients with congestive heart failure (CHF) and after a heart attack. It has been shown to transiently decrease in patients in hemorrhagic shock after trauma and returns to normal after resuscitation in trauma and burn patients. The investigators hypothesize that beta blockers will maintain pre operative heart rate variability in patients with intermediate risk of cardiac events during operative intervention with laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* age 40-75 years old
* intermediate risk of adverse cardiac events:

  * renal insufficiency (CrCl \< 60)
  * diabetes mellitus
  * two of the following:

    * age \> 50
    * obesity
    * hypertension
    * hyperlipidemia
    * hypercholesterolemia
    * prior stroke
  * undergoing an elective laparoscopic abdominal surgery less than three hours:

    * cholecystectomy
    * ventral hernia repair
    * umbilical hernia repair
    * gastric bypass or gastric banding

Exclusion Criteria:

* currently taking a beta blocker
* prior heart attack
* rhythm other than sinus on ECG
* contraindication to beta blockers:

  * decompensated CHF
  * severe valvular disease
  * asthma
  * COPD
  * hypersensitivity to beta blockers
  * heart rate \< 60
* currently taking a calcium channel blocker
* urgent or emergent surgery
Dietary Nitrate and Healthy Older Adults

This study investigates the influence of dietary nitrate supplementation on cardiovascular health and physical and cognitive performance in older adults. Participants will receive both a nitrate containing beetroot juice for 10 days and a nitrate depleted beetroot juice for 10 days

A recent exciting finding is that dietary nitrate supplementation (in the form of beetroot juice) appears to reduce the amount of oxygen needed to complete moderate intensity walking in healthy, young individuals. Nitrate is known to be converted in the body to nitric oxide (NO), a substance which reduces blood pressure and may affect the energy-producing mechanisms inside muscle cells. Exercise tolerance and muscle function typically declines with age and nitrate supplementation therefore may help improve cardiovascular health and the ability to carry out low-intensity daily activities in aging populations. The purpose of this study is to see if healthy, elderly individuals benefit from beetroot juice intake similarly to the effects seen in young adults. If this is indeed the case, then it may suggest that dietary supplementation with a relatively cheap, widely available, and natural food product may improve the ability of healthy elderly individuals to undergo everyday tasks and ultimately improve their quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. 70 - 80 years of age
2. male or female

Exclusion Criteria:

1. involved in regular structured exercise
2. receiving medication for:

   * pulmonary conditions
   * cardiovascular conditions
   * metabolic conditions
   * musculoskeletal conditions
   * ulcerative colitis
   * renal disease
Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy

Objective: to determine which regimen results in best glycemic control and safety profile, expressed as glucose values within target range and occurrence of hypoglycemia. Secondary objective is to compare patient satisfaction, clinical outcomes and toxicity.

Study design: Randomized open label cross-over study Study population: Patients ≥ 18 years, who developed glucocorticoid induced hyperglycemia requiring initiation or adjustment of antihyperglycemic agents in a previous chemotherapy cycle. Patient should have ≥2 cycles of chemotherapy scheduled, with 3-10 consecutive days of ≥12,5mg prednisone-equivalent glucocorticoid and a wash-out period of 4-38 days between each cycle.

Intervention: subjects will be treated by insulin regimen A and B in random order during two consecutive cycles of chemotherapy. A) intermediate acting insulin 0.01 IU / mg prednisone-equivalent / kg body weight once daily subcutaneous B) Short-acting insulin according to sliding scale regimen, dose adjusted to current grade of hyperglycemia.

Main study parameters: Difference in fraction of blood glucose measurements (BGM) within target range and occurrence of hypoglycemia.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both study treatments are just a slight variation in regular care for glucocorticoid induced hyperglycemia. Glycemic control is likely to improve due to treatments and increased counselling. All subjects will receive both treatment regimens.

The burden consists of 16-32 extra BGMs over 2 x 4-10 days, wearing the glucose sensor, 1 venipuncture (if HbA1c and creatinin are not determined in routine laboratory within 3 months before start), and 1 randomization visit to the outpatient clinic. Potential risk is the occurrence of hypoglycemia, as is present in any insulin therapy. The investigators account for this risk by giving subjects dietary advice and education how to prevent, recognize and treat hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Written informed consent
* Glucocorticoid induced hyperglycemia in previous cycle of chemotherapy that required therapy initiation or adjustment
* Duration of glucocorticoid cycles 3-10 consecutive days and 4-38 glucocorticoid-free days between 2 cycles
* Prednisone-equivalent dose of ≥ 12,5mg
* At least 2 more cycles of chemotherapy to receive

Exclusion Criteria:

* History of hypo-unawareness
* Continuous tube or parental feeding
* Continuous (maintenance) systemic glucocorticoid therapy
Improvement of Low Back Pain After Decompression in Patients with Degenerative Spinal Canal Stenosis

Degenerative lumbar spine disease is a leading cause of disability in the world; it encompasses conditions such as spondylolisthesis, disc degeneration, and lumbar spinal stenosis. Those conditions present with a variety of clinical symptoms, including lower extremity pain, weakness, and low back pain (LBP) of varying levels of severity and in severe cases urine and stool incontinence may result.

Degenerative lumbar spine disease is a common indication for lumbar decompression surgery, especially in elderly patients. Moreover, Clinical studies prove that decompression is superior to conservative treatment with more favorable outcomes .

Surgical options for decompressing the lumbar spine vary from minimally invasive disc decompression to open laminectomy and foraminotomy.

The surgery aims to improve the quality of life in appropriately selected patients , in the form of improvement of walking distance, lower limbs pain, and other symptoms of spinal compression.

Few papers assessed LBP improvement after lumbar decompression surgery . The common practice that patients with degenerative canal stenosis and low back pain should undergo fusion surgery is not evidence based.

In this study the investigators aim to assess the improvement of clinical symptoms, especially low back pain and lower limbs pain in patients with degenerative lumbar spine disease after undergoing lumbar decompression surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with degenerative lumbar spine disease admitted to Assiut University Hospitals, Department of Orthopaedic and Trauma Surgery between March 2023 and March 2024, to whom lumbar decompression surgery is indicated regardless of age or neurological symptoms.
2. Patients with grade one spondylolisthesis without evident instability can be added.

Exclusion Criteria:

1. Patients who are not available for follow up
2. Patients who refuse to participate in the study
3. Patients with evidence of instability
4. Previously operated patients on the same or adjacent segment.
Role of the Interaction Between Advanced Glycation End Products and Their Receptor RAGE in the Development and the Progression of the Uremic Vasculopathy of Hemodialyzed Patients

Chronic kidney disease (CKD) is associated with an extensive vasculopathy and high cardiovascular mortality as well as an accumulation of uremic toxins. Among the latest, advanced glycation end-products (AGEs) interact with RAGE. Investigators aimed to analyze the role of RAGE in the calcification process of hemodialyzed patients, in a correlative and prospective study. Vascular calcifications will be assessed by Xray and tomodentimetry while accumulation of AGEs will be measured in the serum and in the skin (non invasive). Additionally factors influencing RAGE activation such as genetic polymorphism and level of soluble forms of RAGE will be measured and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Renal impairment
* Hemodialysis for more than 3 months
* Have agreed to participate in research
* Affiliated to a social security scheme
* major

Exclusion Criteria:

* Diabetes , for diabetes induces accelerated formation of advanced glycation end products , which could then be a confounding factor in our study.
* Protected by law .
* minors
* pregnant women
* Matt or pigmented skin because the skin hyperpigmentation interfere with reading the skin fluorescence giving falsely elevated values .
* Having an aneurysm of the abdominal aorta known
* Suffering from a progressive neoplastic disease
Efficacy of HUEXC030 in Subjects With Pulmonary Tuberculosis

Assess the Efficacy of HUEXC030 as Add-on Excipient to Eradicate Anti-Tuberculosis Drugs Induced Hepatic Injury ( ATDH ) in Subjects with Pulmonary Tuberculosis

The study drug is Isoniazid formulated with HUEXC030 as excipient for eradicating ATDH, whereas the reference control is Isoniazid formulated with inactive excipient. Subjects who fulfill all the entry criteria and have written informed consent will be enrolled to the study. Eligible subjects will be randomized in a 1:1 ratio to receive study drug or reference control drug. Subjects will be genotyped according to a selected panel of single nucleotide polymorphisms (SNPs) and categorized into high risk or low risk groups for occurring ATDH via a specific haplotype consists of CYP2E1 and NAT2 SNPs. Based on an extensive study result during 2007 to 2011,the estimated frequency for patients bearing high risk genotypes in Taiwanese population is around 25%. Approximately 352 subjects will be enrolled for genotype screening in order to recruit 88 high risk subjects for each of 44 subjects in the intervention and control arms.

Subjects who are stratified as high risk groups will be administered the test drug or reference control drugs oral daily for 6 months or until treatment completion, i.e. bacteriologically confirmed negative of active M. tuberculosis. Subjects who are of low risk genotype will be removed from study after 8 weeks of study treatment, then return to conventional TB medication under the care of their investigator for at least one follow-up visit at 4 weeks after the End of Study.

Eligibility Criteria:
Main inclusion criteria:

1. A definite case of pulmonary TB
2. Patient who is exposed to 3 or less doses of first-line anti-TB drug treatment for current disease.
3. Age ≥ 20 years
4. Have well documented baseline liver function tests that indicates patient's adequate liver function for enrollment to study.

   i. AST and ALT \< 3x ULN ii. total serum bilirubin \< 2.0 mg/dL

Main Exclusion Criteria:

1. Have alcoholic liver disease or habitual alcohol consumption \> 30 g/day for more than one year
2. Previously diagnosed of:

   i. extra-pulmonary TB without concomitant lung invasion ii. HIV iii. liver malignancy iv. liver cirrhosis v. any other systemic diseases that may cause liver dysfunction
3. Documented history of serious allergic reaction or resistance to isoniazid, rifampicin, ethambutol, pyrazinamide, sugar alcohols or any structurally related compounds
4. Subjects who will be using the following therapies after TB treatment starts:

   i. antiretroviral agents ii. oral corticosteroids
5. Subjects are pregnant or lactating
6. Subjects with child-bearing potential who are not committed to take reliable contraception during the participation of the study and at least 4 weeks after the end of the study treatment
7. Subjects with any other serious disease considered by the investigator not in the condition to enter into the trial
Impact of Exercises and Chair Massage on Musculoskeletal Pain of Young Musicians

The study is tested the idea of two forms of musculoskeletal pain prophylaxis (chair massage and an original set of exercises) among musicians.

The hypothesis of the study was that massage and exercises could be helpful for musicians to avoid pain conected with playing musical instrument.


Eligibility Criteria:
Inclusion Criteria:

* playing a musical instrument for a minimum of 5 years
* age over 18 years

Exclusion Criteria:

* neurological and oncological diseases
* medical contraindication to undertake physical exercise
* contraindications to perform massage
* lack of consent for participation in the study
Local and Intravenous Dexamethasone on Post Operative Pain a After CS

A Prospective, randomized study conducted on 120 pregnant women attending the labour wards in Kasr Al Ainy and Fayoum maternity hospitals from May 2014 to December 2015. All participants were scheduled for elective cesarean section under spinal anaesthesia and were randomly divided into 3 equal groups. Group 1(40 women) received 16 mg Dexamethasone IV drip. Group II (40 women) received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure and Group III received Placebo in the form of IV fluids 500 cc saline infusion. All cases were followed up for 48 hours for assessment of level of pain by using a 10-cm visual analog scale (VAS). Primary outcome parameters were VAS score and the need for additional analgesics. Other parameters were hemodynamic changes and occurrence of side effects or complications

The patients were subjected to history taking, including age, parity, menstrual history for verification of gestational age and medical history for confirmation of inclusion and exclusion criteria. Full general and abdominal and obstetric examinations were done. Investigations including complete blood picture, liver functions and coagulation profile to exclude those not fitting with the above listed criteria. Ultrasound was done to assess gestational age.

Patients were checked for coagulation abnormalities. Large gauge (18G) cannula was inserted in cephalic or ante cubital veins. Patients were preloaded with HAES- steril 6% (hydroxyl ethyl starch) Fresenius. Or, preloaded with ringer's lactate 20 ml/kg. Patients were positioned in the sitting position for spinal anaesthesia and sterilization of the back was done using Betadine. L3-L4 space was determined for the insertion of spinal needle. Then 25G spinal needle was used to perform a single shot spinal anaesthesia using 10mg of 0.5% hyperbaric Bupivicaine and Fentanyl 20 micrograms.

All surgeons had close surgical skills and used the same technique transverse lower segment incision.

The procedure is then completed using traction on cord to deliver the placenta, exteriorization of uterus, closure of uterine incision in 2 layers, closure of both visceral and parietal peritoneum, closure of rectus sheath, no subcutaneous closure and finally subcuticular skin closure. Follow up for all cases for 48 hours. Primary outcome parameters were VAS score and the need for additional analgesics. Other parameters were hemodynamic changes and occurrence of side effects or complications.

Eligibility Criteria:
Inclusion Criteria:

* All participants were scheduled for elective cesarean section under spinal anaesthesia

Exclusion Criteria:

* Women with neurological disorders
* Psychologically disturbed
* Those with uncontrolled hypertension, Diabetes Mellitus, peptic ulcer, liver cirrhosis or glaucoma
* Women with systemic infections
* Allergy to Dexamethasone
* Contraindications to spinal anaesthesia