cyrilzakka/clinical-trials huggingface dataset:
Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit

Trimethoprim/sulfamethoxazole (TMP/SMX, cotrimoxazole) is the first-line therapy for Pneumocystis jirovecii pneumonia and bacterial infections in critically ill patients, where acute kidney injury (AKI) and renal replacement therapy (RRT) are regularly observed. Both may change half-life and subsequent concentrations. Specifically, Trimethoprim (TMP) is eliminated renally, whereas sulfamethoxazole (SMX) elimination is 80%metabolic/20%renal. Despite decades of cotrimoxazole use, data in acute kidney injury (AKI) are scarce and no consensus on dosing strategy has been established. Besides, pharmacodynamic parameter has not been determined, leading to an uncertainty on the dosing regimen.

The objective is to compare the plasma concentrations of patients with acute renal failure (ARF) or requiring extra renal replacement therapy (RRT) with those of patients without these characteristics to look for differences in concentration.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in Intensive Care Units between October 2020 and July 2021 with infection treated with cotrimoxazole

Exclusion Criteria:

* None
Angiotensinogen Gene and Hypertension

Genetic studies of hypertension, focusing on renin-angiotensin system genes and other interacting genes


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertension

Exclusion Criteria:

* Patients with hypertension and reluctant for the study
A RCT Study in Schizophrenia Relapse Prevention

THE AIM OF THE PROJECT The main aim lies in the prevention of frequent relapses typical for schizophrenia and schizoaffective disorder by means of simple, highly cost-effective information technology-aided approach RESEARCH HYPOTHESIS A the end of 18 months study duration, patients in the active group enrolled in ITAREPS will demonstrate statistically significantly reduced risk of hospitalization, decreased number of hospitalization days and reduced direct inpatient costs in comparison to control group not using the program.

The ITAREPS 2.0 program employs telecommunication and information technologies in order to detect fluctuations in longitudinal mental health status of patient with schizophrenia and thus signalize the very early stages of prodromes preceding relapse. This approach opens an avenue towards early pharmacological intervention. Subjects (150 patients with diagnosis of schizophrenia and schizoaffective disorder and their family members) will be randomized at a 1:1 ratio into the active or control group. Participants from the active group will be completing two separate versions of the 10-item Early Warning Signs Questionnaire (EWSQ) upon a weekly SMS request generated automatically by the system during 18 months study duration. In this group, automatically generated e-mail alert message feedback to the investigator will be activated in case of prodrome detection, prompting investigator to antipsychotic dose increase by 20%. The control (treatment-as-usual) group will not use ITAREPS system.

Eligibility Criteria:
Inclusion Criteria:

For entry into the study, the following criteria MUST be met:

* Men and women, ages 18 to 60 years, inclusive.
* A diagnosis of schizophrenia or schizoaffective disorder according to ICD-10 classification.
* Having at least TWO psychiatric hospitalization for psychosis before the study enrollment.
* Severity (CGI-S) ≤ 3 at study Visit 1.
* All patients must be on stable doses of antipsychotic medication during the study entry.

Exclusion Criteria:

* Organic mental disorder,
* mental disorder due to psychoactive substance use or mental retardation.
* Participation in another relapse prevention program.
* Hayward compliance rating scale score \< 2 at Visit 1.
Ureteral Stent-related Pain and Mirabegron (SPAM) Trial

Ureteric stents are used often following ureteroscopy for prevention of obstruction from edema and or stone fragments. They are often associated with pain, voiding often, the need to urinate quickly and finding blood in the urine called "lower urinary tract symptoms" or LUTS for short. There is randomized studies showing the efficacy of α-blockers such as tamsulosin in relieving "stent symptoms" (pain and LUTS). There is emerging but limited evidence to show that antimuscarinic medications, used to treat overactive bladder (OAB) have some efficacy in decreasing stent symptoms. Mirabegron is a beta-agonist used to decrease OAB symptoms.

Mirabegron functions to mediate relaxation of the detrusor muscle and has been useful in treating OAB symptoms. Conventional antimuscarinic medications often have bothersome side effects like dry mouth, constipation, blurred vision and cognitive impairment. This may limit their use in some populations. Mirabegron is well-tolerated with a good safety profile and therefore may be useful in treating stent symptoms without the bothersome side effects commonly seen with antimuscarinic medications. .

The investigators hypothesize that mirabegron is effective in decreasing ureteral stent related LUTS and pain.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* First presentation for ureteroscopy for this particular stone
* Planned insertion of double J ureteral stent
* Planned ureteral stenting ≥5 days
* Follow-up conducted at the Queen Elizabeth II Health Sciences Centre

Exclusion Criteria:

* Bilateral ureteral stents to be inserted
* Stent already in situ prior to ureteroscopy
* Patients with congenital renal abnormalities (ie: horseshoe kidney, ectopic kidney, etc)
* Patients with urinary diversion
* Patients with a history of interstitial cystitis/painful bladder syndrome, chronic prostatitis, or neurogenic bladder
* Indwelling foley catheter
* Active urinary tract infection
* Patients currently taking antimuscarinics, mirabegron, or α-blockers
* Patients with contraindications to receiving either mirabegron or tamsulosin (ie: urinary retention, end-stage renal disease, orthostatic hypotension, uncontrolled hypertension, known QT prolongation, severe aortic regurgitation), significant cognitive impairment, pregnancy, and active urinary tract infection
* Planned upcoming elective cataract surgery
* Suspected or confirmed ureteral perforation
Effect of Bilateral Transcutaneous Tibial Nerve Stimulation on Postpartum Constipation

This study will be conduct to determine the effect of bilateral transcutaneous tibial nerve stimulation on treating postpartum constipation

TTNS was effective in treating constipation .It was believed that re-establishment of normal colonic function may be possible with neuromodulation of sacral nerve stimulation (SNS) that may improve constipation symptoms but it is expensive and invasive . Percutaneous tibial nerve stimulation (PTNS) is an alternative method of neuromodulation that has shown efficacy in constipation and it stimulates L4-S3 nerve roots of sacral plexus that supply the pelvic floor and lower gastrointestinal tract, Transcutaneous tibial nerve stimulation (TTNS) targets the tibial nerve in a similar fashion to PTNS but it is cheaper and does not require needle puncture .There were few studies showed that TTNS has been used and shown to be effective for treating constipation, but till now, there is no previous study illustrating it's effect specifically on postpartum constipation. So, this study will be the first one in this issue.

Eligibility Criteria:
Inclusion Criteria:•Postpartum women, delivered by caesarean section suffering from constipation after delivery.

* Their ages will range from 20 to 35 years old.
* Their body mass index (BMI) will range from 25 to 33 kg/m2.
* All participating women should have at least two criteria of Rome III diagnostic criteria for constipation.

They should stop laxatives intake during treatment program

-

Exclusion Criteria:

Postpartum women will be excluded if they have:

* History of inflammatory bowel disease, and irritable bowel syndrome.
* Endocrine disease or digestive tract disease.
* History of genital prolapse and anal fissure.
* Congental anorectal malformation, stoma in situ.
* Diabtes mellitus and sever distal venous insuffiency.
* Skin eruption at the site of stimulation.
* Implanted pacemaker or defibrillator.
* Metalic implant in lower limb.
* Recent surgery at the lower limb.
* Peripheral neuropathy and neurological disorders. Psychological distress.
Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles vs. Flexor Muscles Alone for Treatment of Essential Hand Tremor(FLEX-D ET)

To compare the efficacy of botulinum toxin (BoNT) injections in forearm flexors plus extensor muscles versus flexors alone for the treatment of essential hand tremor (ET).

The investigators propose a pilot, single center, double blind, randomized, parallel, placebo controlled trial comparing 2 (BoNT) injection patterns for treatment of moderate to severe essential tremor. The investigators will recruit 20 patients with (ET).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and over, male or female patient with (ET) involving at least their dominant hand, as diagnosed by a movement disorders neurologist.
2. Having bothersome hand tremor in dominant hand with a hand TRS ≥2
3. On stable medications during last 30 days prior to enrollment.

Exclusion Criteria:

1. Presence of secondary causes of tremor, such as dystonia and parkinsonism
2. Any contraindication to botulinum toxin injections (e.g. motor neuron disease, neuromuscular junction disease, etc.)
3. History of surgical treatment for (ET).
4. Dementia as defined by DSM-V criteria
5. Patients with suboptimally treated depression and significant depressive symptoms as defined by a PHQ-9 score of ≥15 (PHQ-9 scores 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression). Antidepressant medications, prescribed for depression or anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.
6. Patients with suboptimally treated anxiety and significant anxiety symptoms as defined by a GAD-7 score of ≥15 (GAD-7 scores 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety). Anti-anxiety medications, prescribed for anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.
7. Significant renal, hepatic, cardiac and thyroid disease
Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan)

The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.

All the patients whom an investigator prescribes the first Lyrica® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be administered Lyrica® in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Lyrica®.
High Frequency Chest Wall Oscillation and Cystic Fibrosis

High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucus clearance compared with a control group. These observations led to the development of The Vest® which is a non-stretchable jacket connected to an air-pulse generator and worn by the patient over the chest wall. The generator rapidly inflates and deflates The Vest®, which gently compresses and releases the chest wall between 5 and 20 times per second. This generates mini-coughs that are said to dislodge mucus from the bronchial walls and to facilitate its movement up the airways. The Vest® has been shown to reduce the viscosity of mucus and this should further enhance mucus clearance.

People with cystic fibrosis (CF), admitted to hospital with an acute infective pulmonary exacerbation, should increase the frequency and duration of their airway clearance sessions owing to the increase in quantity and viscosity of purulent bronchial secretions.In the United Kingdom, and in many other countries, the availability of physiotherapists to assist with the recommended number of daily treatments is insufficient to meet patient need. If the use of high frequency chest wall oscillation, in addition to 'usual' self airway clearance techniques, in the early morning and evening was to facilitate recovery from an exacerbation, this would indicate an important place for high frequency chest wall oscillation in the management of people with cystic fibrosis.

Hypothesis:

The addition of high frequency chest wall oscillation to twice daily supervised physiotherapy is as effective as the addition of self treatment in facilitating recovery from an acute infective pulmonary exacerbation, as measured by improvement in lung function, specifically forced expiratory volume in one second (FEV1).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis
* Hospitalised patients admitted with a pulmonary infection
* Forced expiratory volume in one second (FEV1)of 15% predicted or over
* 16 years of age or over

Exclusion Criteria:

* Current severe haemoptysis
* Rib fractures or history of spontaneous rib fractures
* pregnancy
* Lung abscess
* End stage disease
* Requiring more than two assisted treatment sessions per day
* Requiring treatment with positive pressure
* Inability to give consent
Validation of a Comprehensive Older Adult Screening Tool (COAST)

The COAST nutrition screening tool will be validated in 300 community-dwelling older adults in Florida.

The population to be studied (n=300) will be individuals who are 60 years or older and participate in congregate meal sites or other community groups in Florida. Demographic information will be collected and participants will be assessed by the MNA® (Mini Nutrition Assessment) and screened by the COAST nutrition screening tool. Participants' hand grip strength and performance on the five times Sit to Stand test will be used to evaluate their functional status. Weight, height, mid-arm circumference and calf circumference will be measured as part of the MNA screening tool.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling adults 60 years and older.

Exclusion Criteria:

* Non-English speaking/reading
Additional Effect of Cranial Base Release on Cervical Range and Proprioception in Patients With Mechanical Neck Pain

Mechanical Neck pain is the second most commonly occurring musculoskeletal disorder worldwide, ranking 4th in overall disability. It is referred to as Nonspecific generalized neck pain with mechanical characteristics with a primary location between the supranuchal line and the first thoracic spinous process, includingpatients suffering from mechanical neck pain are reported to have several impairments, including pain, reduced cervical ROM, neck disability, and proprioceptive dysfunction. The treatment indicated involves the use of electrotherapy and thermal modalities. In addition, the use of different manual therapy techniques is advocated; however, the most effective management is still debatable. Evidence suggests that Natural Apophyseal glides have a significant positive effect on mechanical neck pain patients. So the study will identify the additional effect of cranial base release with natural apophyseal glides in alleviating pain and its effects on proprioception.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with mechanical neck pain having reproducible non-specific neck pain with a primary location between the supranuchal line and the first thoracic spinous process
* Male and Female
* Age 18-40 years
* Pain severity on NPRS \>3
* Neck Disability score of 20% or above
* Problem not older than 2 months

Exclusion Criteria:

* Patients with history of
* Recent significant trauma (including whiplash)
* Radiculopathy
* Cervical fracture
* Neck surgery
* Dizziness, vertigo
* Myelopathy, Malignancy
* Metabolic disease
* Diagnosed Osteoporosis, Rheumatoid arthritis
* Long-term corticosteroid and/or painkiller drug use
Study and Management of Cystic Complications in Autosomal Dominant Polycystic Kidney Disease

Autosomal dominant polycystic kidney disease is characterised by the development of renal and hepatic cysts. While the main complication is chronic end-stage renal failure, specific cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst infections, cyst-related mechanical complications and lithiasis. To date, there is no reliable epidemiological data on the frequency and clinical impact of these complications. Diagnosis of these complications is often complicated, and their management has not been codified. The latest international recommendations (KDIGO) provide only low-level recommendations. For the most complex cases (recurrent cystic infections, resistant pain, mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.), practitioners are often at a loss and management varies greatly from one centre to another.

Autosomal dominant polycystic kidney disease is characterised by the development of renal and hepatic cysts. While the main complication is chronic end-stage renal failure, specific cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst infections, cyst-related mechanical complications and lithiasis. To date, there is no reliable epidemiological data on the frequency and clinical impact of these complications. Diagnosis of these complications is often complicated, and their management has not been codified. The latest international recommendations (KDIGO) provide only low-level recommendations. For the most complex cases (recurrent cystic infections, resistant pain, mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.), practitioners are often at a loss and management varies greatly from one centre to another.

Eligibility Criteria:
Inclusion Criteria:

* Patient with autosomal dominant polycystic kidney disease (APKD) participating in the Genkyst study
* Patient with at least one cystic complication. The cystic complications retained are the following:

  * Acute or chronic cyst-related pain requiring analgesic treatments
  * Cyst infection
  * Intracystic haemorrhage
  * Urinary lithiasis
  * Functional complaints related to the cystic mass: digestive disorders with eating disorders, undernutrition, diaphragmatic compression phenomena, portal hypertension, umbilical or linea alba hernias, ventrations
  * Need for a cystic reduction procedure: puncture, marsupialization, open surgery (including preparation for grafting)

Exclusion Criteria:

* Patients who have expressed their opposition to taking part in the study
* Patient under legal protection (guardianship, curatorship, etc.)
A Randomized Crossover Study to Determine the Pharmacokinetics of Intranasally Administered Acetaminophen in Healthy Adults

This study is being done to determine the systemic absorption of nasally inhaled acetaminophen (Tylenol®) versus orally ingested acetaminophen by comparing the serum drug concentrations of the two groups obtained at various times after study drug administration.

This study is aimed at addressing a significant void in the current literature regarding nasally administered acetaminophen pharmacokinetics. The pharmacokinetics of acetaminophen following oral and rectal administration have been well studied but to date there are no published studies determining the pharmacokinetics of acetaminophen following intranasal administration. This route is currently popular among heroin users. Understanding the pharmacokinetics of nasally administered acetaminophen will help physicians address the important clinical implications of acetaminophen toxicity in this population.

Ten healthy adult volunteers age 18 to 45 years will be recruited for this pilot project. Study participants will be randomized in permuted blocks to receive either oral or intranasal administration of a standardized 500 mg dose of acetaminophen. Blood samples will be drawn from a peripheral intravenous catheter at 0, 5, 15, 30, 45, 60, 90, 120, 150, 240, 360, and 480 minutes after study drug administration and sent to the laboratory for determination of serum acetaminophen concentration. After a one week washout period, each participant will cross over to receive 500 mg of acetaminophen via the remaining route of administration in the second arm of the study. The serial acetaminophen concentrations will be utilized to perform pharmacokinetic calculations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers 18 to 45 years of age

Exclusion Criteria:

* Known hypersensitivity to acetaminophen
* Prior dosing of acetaminophen or product containing acetaminophen in the preceding 7 days
* Hepatic insufficiency and/or failure, or any known liver disease
* History of nasal polyps
* History of nasal trauma in past 14 days
* History of nasal bleeding in past 14 days
* History of asthma, emphysema or any serious respiratory diseases
* Pregnancy or breastfeeding
Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Peripheral Nerve Injury

The purpose of this study is to determine safety and efficacy of pl-vegf165 ("Neovasculgen") for regeneration of peripheral nerve. Pl-vegf165 ("Neovasculgen") is the permitted in Russian Federation angiogenic medication that induce growth of new vessels and included in a complex therapy for patients with peripheral arterial diseases in Russia. It has also been shown to enhance nerve regeneration and muscle reinnervation in animals but these properties have not previously been studied in patients. Moreover, currently there is no method in clinical use to speed the rate of recovery after nerve injury. The objective of this study is to explore the ability of pl-vegf165 to benefit the treatment of patients with peripheral nerve injury. The investigators hypothesize that treatment with intraneural injections with pl-vegf165 after peripheral nerve reconstruction will accelerate nerve regeneration, reduce the period of denervation and improve muscle reinnervation and recovery in patients with peripheral nerve injury.

All patients enrolled into the study will receive standard surgery procedures indicated in accordance with medical care standards for the certain disease. Patients after nerve injury classified as neurotmesis will receive surgical repair of injured nerves what will be added by intraneural injections of pl-vegf165. Safety and efficacy of gene therapy will be assessed by physical examination, comprehensive laboratory tests over next 18 month after surgical nerve reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed transection injury between shoulder and wrist
* Isolated injury of ulnar or median nerve (not mixed injury of several nerves)
* Nerve injuries which are amenable to direct end-to-end repair
* Length of the gap between of stumps of transected nerve no longer than 3,5 centimeters
* Early delayed (secondary) repair performed between 2 to 6 weeks after nerve injury

Exclusion Criteria:

* Length of the gap between of stumps of transected nerve more than 3,5 centimeters
* Simultaneous injury of several peripheral nerves
* Localization of nerve injury beyond of forearm
* Presence of neurological deficit preceding to nerve injury
* Systemic disease of connective tissue
* Myopathy
* Large surgical procedures planned for next one and a half year
* Presence of oncological diseases
* Pregnancy and breastfeeding
* Alcohol and drug addiction
* Patient ability to adhere strictly to the rules of the current clinical trial protocol