cyrilzakka/clinical-trials huggingface dataset:
Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy

To evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive type 1 diabetic patients.

Double-masked, randomized, crossover trial. In random order, patients will be treated with spironolactone 25 mg o.d. and matched placebo for 28 days.

On the last day of treatment, GFR will be determined twice on the same day: first without clonidine and secondly after injection of clonidine (clonidine induces a transient reduction in blood pressure, with no influence on renal plasma flow and GFR), in order to evaluate the effect of antihypertensive treatment with spironolactone on renal autoregulation of GFR.

The study will be preceded by a wash-out period of 1 month for patients receiving antihypertensive medication. Patients will be instructed to measure blood pressure twice daily, three days a week during this period. If, during the washout period, blood pressure exceeds 170/105 mm Hg or persistent edemas develop, treatment with long-acting loop diuretics will be initiated and continued throughout the rest of the study. If blood pressure despite diuretic treatment still exceeds 170 mm Hg systolic and/or 105 mm Hg diastolic, the patient will be excluded from the study and previous/appropriate antihypertensive treatment will be restarted.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Age between 18 and 70 years
* Blood pressure ≥ 135 mm Hg systolic and/or ≥ 85 mm Hg diastolic or ongoing antihypertensive treatment
* Informed consent

Exclusion Criteria:

* Diabetic nephropathy
* Other known kidney or renal tract disease
* Malignant hypertension
* Blood pressure \> 170/105 at baseline or during AHT wash-out period
* Plasma potassium \> 4.7 mmol/l
* Elevated plasma creatinine (\>88 µmol/l for women and \>100 µmol/l for men)
* Symptoms of Ischemic heart disease within 3 months prior to study start
* Previous cerebrovascular event (apoplexy, TCI)
* Abuse of medicine or alcohol
* Pregnancy or breastfeeding
* Woman of child-bearing age who are not using adequate contraception
* ASA treatment \> 1g/day or regular use of NSAIDs
* Known allergy to or side-effects of spironolactone
* Inability to understand patient information
Ilium Mobilization in Patellofemoral Pain Syndrome Treatment

Aim of the study is to investigate the effect of adding posterior ilium mobilization on knee pain, knee function, anterior pelvic tilt, dynamic knee valgus, muscle strength of extensors, abductors and external rotators of hip and knee extensors in patients with patellofemoral pain syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Age of the subjects between 18-35 years.
2. BMI will be ≤ 29.5
3. Anterior or retro patellar knee pain for at least 6 weeks duration.
4. Foot posture index score from +6 to +12.
5. Anterior pelvic tilt angle more than 8 degree.
6. Pain elicited at least by two of the following four tests; (i) Isometric muscle contraction with slight bent knee,(ii) palpation of the patellofemoral joint line, (iii) patellar compression against the femoral bone (iv) active resisted knee extension.
7. Pain intensity more than 3 at ANPS and provoked by at least two of the following activities: running, walking, hopping, squatting, stair negotiation, kneeling, or prolonged sitting.

Exclusion Criteria:

1. Meniscal or other intraarticular pathologic conditions; cruciate or collateral ligament involvement.
2. A history of traumatic patellar subluxation or dislocation.
3. Previous surgery in the knee, ankle and hip joints.
4. Knee, ankle and hip joints osteoarthritis.
5. Taking non-steroidal anti-inflammatory drugs or corticosteroids within 24 h before the test.
6. History of brain injury or vestibular disorder within the last 6 months.
7. Pregnant female.
Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism

This is a non-randomized, open-label, single arm, self-controlled study of XP-8121 (levothyroxine sodium) to determine a target dose conversion factor from stably dosed oral levothyroxine to XP-8121 (levothyroxine sodium) in patients with hypothyroidism and to assess the safety and tolerability of XP-8121(levothyroxine sodium) after once weekly subcutaneous injections. This study includes the following periods: Screening, Titration Period, and Maintenance Period. The study will conclude with an End of Maintenance Visit or Early Termination (ET) Visit.

This is a non-randomized, open-label, single arm, self-controlled study of XP-8121 (levothyroxine sodium) to determine a target dose conversion factor from stably dosed oral levothyroxine to XP-8121 (levothyroxine sodium) in patients with hypothyroidism and to assess the safety and tolerability of XP-8121 (levothyroxine sodium) after once weekly subcutaneous injections. This study includes the following periods: Screening, Titration Period (2 to 8 weeks), and Maintenance Period (4 weeks). A pharmacokinetic substudy will be conducted for a subset of patients during the Maintenance Period. The study will conclude with an End of Maintenance Visit or Early Termination (ET) Visit.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent.
* Male or female between the ages of 18 and 65 years (inclusive) at Screening, with chronic hypothyroidism and on a stable dose of oral levothyroxine (Synthroid or an FDA-approved generic equivalent to Synthroid) or, if in the pharmacokinetic substudy, Synthroid only for at least 3 months.
* TSH within the normal range at Screening (central laboratory) and at least 3 months prior to Screening (documented by local laboratory).
* Free thyroxine within the normal range at Screening (central laboratory).

Exclusion Criteria:

* History of hypersensitivity to levothyroxine (any formulation).
* Current dose of oral levothyroxine, based on body weight \>2 μg/kg/day.
* Current levothyroxine total daily dose either \<50 μg or \>375 μg.
* Current use of combined thyroid treatment (i.e., Synthroid plus liothyronine or Synthroid plus Armour Thyroid) and/or any other levothyroxine aside from those used in the study.
Intravenous Fluids After Laparoscopic Cholecystectomy

Perioperative intravenous fluid (IV) administration has been the standard procedure since 1832 and, is a widely used practice sometimes under inadequate criteria. The present work aims at verifying the clinical need that justifies the common IV fluid prescription on the postoperative (PO) period in patients undergoing videolaparoscopic cholecystectomy (CVL) elective.

Patients undergoing elective laparoscopy cholecystectomies were randomized to either routine practice fluid prescription (control group) or no IV fluids in the postoperative period. Thirst, hunger, presence of nausea and vomiting, renal function and personal satisfaction were assessed.

Body composition was evaluated by bioimpedance

Eligibility Criteria:
Inclusion Criteria: Elective laparoscopy cholescitectomy; no intraoperative complication -

Exclusion Criteria: Co-existing severe renal failure, cardiac failure or pulmonary disease

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Experimentally Testing the Effectiveness of a Campus-based Bystander Intervention

The purpose of this study was to examine the impact of a bystander intervention education program on college students' attitudes and behaviors associated with bystander intervention and sexual violence.

This study used a randomized control trial, longitudinal design to determine the impact of a peer education theater intervention on undergraduate student attitudes and behaviors related to sexual violence and bystander intervention. Students were assigned to either an experimental group (receiving 3-4 doses of the intervention ) or a comparison group (receiving 1 dose only) and were surveyed six times over an 18 month period.

Eligibility Criteria:
Inclusion Criteria:

* Incoming first year students in the fall semester of 2010
* Age 18 - 21
* Attended Summer Orientation session

Exclusion Criteria:

* Incoming transfer students
* Younger than 18 or older than 21
Behavior and Driving Safety Study II

The purpose of this study is to determine whether brief motivational interviews reduce problematic drinking behavior among individuals arrested for the first time for driving under the influence of alcohol (DUI).

Despite extensive legislative, law enforcement, and public awareness efforts, driving under the influence of alcohol (DUI) remains a major cause of mortality and loss of years of productive life. A brief motivational interview (BI) is a non-confrontational, patient-centered discussion during which the individual's motivation and confidence to change health-related behaviors are explored. Previous studies of BIs in health care settings suggest that BIs administered after hospitalization for alcohol-related injury reduce the likelihood of repeat injury hospitalization and arrest for DUI. This study will evaluate whether brief motivational interviews reduce problematic drinking behavior among individuals arrested for the first time for driving under the influence of alcohol (DUI).

Eligibility Criteria:
Inclusion Criteria:

* First arrest for driving under the influence of alcohol
* Arrest involved operation of a motor vehicle
* At least 18 years of age
* English-speaking

Exclusion Criteria:

* Arrest involved injury to another person
Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?

The investigators want to prove that people WITHOUT advanced cancer who are taking opioid medications (for problems like back pain) can receive methylnaltrexone (MNTX) safely. Since the FDA has only approved MNTX for advanced cancer patients, the investigators' research is investigating how MNTX can work for NON-cancer patients. This research is being conducted to prove that MNTX can work for non-cancer patients with opioid related constipation.


Eligibility Criteria:
Inclusion Criteria

1. Age 18 and greater
2. Clinical diagnosis of constipation
3. Any patients that report taking an opioid analgesic for greater than two (2) weeks (eg known oncology patients and chronic pain syndrome patients, including those with low back pain or sciatica)
4. Patients must have previously tried a stable laxative regiment for at least three (3) days prior to study entry.
5. All patients will have a flat and upright abdominal x-ray, and chest x-ray to exclude gastrointestinal (GI) obstruction. Any patients who have radiographic evidence of GI obstruction will need a CT scan of the abdomen to exclude GI obstruction prior to study enrollment.
6. Females of childbearing potential must have a negative pregnancy test and must be encouraged to use appropriate birth control for a period after the study.
7. Willing to comply with study instructions and sign an informed consent

Exclusion Criteria:

1. Pregnancy or lactation
2. Recent surgery within six (6) weeks of the emergency department visit
3. Opioid withdrawal syndrome as determined by clinical judgment.
4. Patients with previous history of diabetic gastroparesis.
5. Any patient who has known or suspected gastrointestinal obstruction
6. Any patients with creatinine clearance ≤ 30 mL/min
7. Constipation for which other medical causes cannot be excluded such as anticholinergic medications, botulinum toxin, or botulism.
8. Any patient with SBP ≤ 80 mmHg or DBP ≤ 45 mmHg or unstable vital signs.
9. Inability to understand or follow the instructions associated with the clinical study as determined by clinical judgment.
10. A known history of substance abuse on methadone maintenance therapy \> 12 months
11. Allergy or contraindication to use of methylnaltrexone
12. Prior enrollment in study
Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

This randomized controlled trial examines whether the addition of a low-dose dexmedetomidine infusion to our current multimodal pain management plan decreases narcotic consumption and reduces side effects in adolescent patients undergoing posterior spinal fusion for idiopathic scoliosis.

Patients will assigned to one of two groups. Either the intervention group where they will receive a dexmedetomidine infusion at 0.2mcg/kg/hr for 48 hours post-operatively or the control group where they will receive a normal saline infusion for 48 hours post-operatively in addition to our hospitals standard pain management protocol. Pain scores will be recorded and patients will fill out a brief questionnaire every 48hours about their pain control and side effects (pruritus, nausea, vomiting, drowsiness).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic scoliosis
* Undergoing a posterior spinal fusion of at least 5 levels with both thoracic and lumbar involvement

Exclusion Criteria:

* Known allergy to dexmedetomidine or any of the standard medications used intra or post operatively
* Patients with a history of chronic pain currently taking opioids, TCA's, Gabapentinoids
* Medical contraindications to administration of dexmedetomidine, unstable cardiac status, (prolonged Qtc, life threatening arrhythmias, use of digoxin)
* Moya Moya disease
Transcranial Electrical Stimulation With Visual Comfort for Treating Chronic Pain in Inflammatory Demyelinating Diseases

Non-invasive neurostimulation can effectively improve patients' symptoms and has shown good therapeutic efficacy in alleviating the symptoms of IIDDs (Inflammatory Immune-mediated Demyelinating Diseases). However, some patients have not achieved the desired results, which may be due to individual differences in neural responsiveness \[20\]. Therefore, this study aims to assess the therapeutic effect of transcranial electrical stimulation combined with visual placebo on improving symptoms such as painful spasm in IIDDs patients, by considering both the overall characteristics of IIDDs disease symptoms and individual differences in patients. The study will explore the imaging characteristics, electrophysiological features of the disease symptoms, and their relationship with clinical manifestations, while analyzing the key factors that influence treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with neuromyelitis optica spectrum disorder, multiple sclerosis, or other central nervous system inflammatory demyelinating diseases that meet the diagnostic criteria;

Numeric Rating Scale (NRS) pain score ≥4;

Age between 18 and 65 years, regardless of gender;

Stable dose of immunosuppressive therapy for at least one month;

EDSS score ≤6;

Right-handed;

Agree to participate and sign the informed consent form.

Exclusion Criteria:

A history of relapse within the past month;

Recent medication adjustments or treatment with modified electroconvulsive therapy, transcranial magnetic stimulation, or other neurostimulation techniques within the past month;

Participation in any other clinical trial within the past month or currently participating in another clinical trial;

Presence of cochlear implants, pacemakers, or implanted stimulators in the brain;

Skin integrity at the electrode placement site is compromised, or allergy to electrode gel or adhesive;

A history of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections;

Pregnant or breastfeeding women, or those planning to become pregnant in the near future;

A score of ≥3 on item 3 (suicide item) of the HDRS-17, or a history of severe psychiatric disorders;

Presence of severe or unstable organic diseases;

Poor patient compliance preventing cooperation with treatment, follow-up, or clinical, EEG, and imaging data collection;

Any other situation deemed unsuitable for participation in the study by the investigator.
Phase 3 Safety Study for the Treatment of Presbyopia Subjects

Safety Study of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Safety Study: Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Eligibility Criteria:
Inclusion Criteria:

1. Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
2. Be able and willing to follow all instructions and attend all study visits;
3. Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
4. Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1;
5. Have +1.00 to -4.00 diopter(D) of sphere calculated in minus cylinder (up to 2.00D of cylinder) in both eyes determined by manifest refraction documented at Visit 1

Exclusion Criteria:

1. Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
2. Have known contraindications or sensitivity to the use of any of the study medications or their components;
3. Have an active ocular infection at Visit 1 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye;
4. Have moderate or severe dry eye defined as total corneal fluorescein staining at Visit 1;
5. Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam at Visit 1
The Depth of Endotracheal Tube Insertion

The investigators suppose that direct laryngoscopy is connected with deeper insertion of endotracheal tube in comparison to videolaryngoscopy. Correction of this malposition can cause postoperative discomfort and further complications in some patients.Routine use of videolaryngoscopy could minimize these problems.

100 patients scheduled for elective neurosurgical procedures will be randomized into two groups. Patients in group A will be intubated by videolaryngoscopy (GlideScope), patients in group B by direct laryngoscopy, in both groups will be rigid stylet used. Intubation will be done under propofol anesthesia, targeted entropy 40 to 50, and deep relaxation (neuromuscular transmission target level 0). Sufentanil will be used to block tracheal reflexes. In both groups the depth of insertion of tracheal tube will be measured in the mouth corner immediately after intubation. Next day, the unpleasant sensations and complications will be recorded (sore throat, stridor, hoarseness, cough and nausea and vomiting) during control visit of patients.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I - III

Exclusion Criteria:

* postoperative ventilation, laryngeal tumors, conditions after tracheotomy or laryngeal operations, cervical spinal hernia extraction
Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes

Small airway inflammation and dysfunction will be measured in 40 children and 40 adults with asthma before and after 8 weeks of treatment with inhaled budesonide. The same measurements will be conducted once in 80 age and sex matched healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* symptoms of asthma and objective evidence of variable or reversible airway obstruction according to at least one of the following criteria
* significant response to bronchodilator (in subjects 7 years or older: FEV1 (forced expiratory volume in 1st second) or FVC (forced vital capacity) increases at least 12 % and 200 ml; in 4-6 years old subjects R5 decreases at least 40 %)
* in at least 12 years old subjects significant diurnal variation (at least 20 % and 60 l/min on at least three days) or significant response to bronchodilator ( at least 15 % and 60 l/min on at least three occasions) in PEF (peak expiratory flow) during a two-week monitoring
* significant airway hyperreactivity (PD20 FEV1 of methacholine less than 600 µg in at least 16 years old subjects, FEV1 decreases at least 15 % in exercise test in 7-15 years old, or R5 increases at least 40 % during free-running test in 4-6 years old subjects)

Exclusion Criteria:

* current smoking
* regular anti-inflammatory asthma medication (will be paused for at least 4 weeks before enrollment)
* other chronic pulmonary disease
* other diseases that in the opinion of the treating physician prevents participation
His Bundle Recording From Subclavian Vein

His bundle pacing has been proposed as a superior alternative to standard right ventricular pacing. The purpose of this study is to investigate whether obtaining a His Bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath can be done in a quick and reliable manner. This would support the use of stylet driven leads for His bundle pacing.

The purpose of this prospective observational study is to investigate whether obtaining a His Bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath can be done in a quick and reliable manner. Included in the study are patients undergoing permanent pacemaker implantation at Good Samaritan and Bethesda North Hospitals. The main outcome is successful recording of a His bundle potential. Secondary outcomes are the time necessary to record the His bundle and the measurement of the pacing threshold.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years Male or Female Patients undergoing HIS bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath

Exclusion Criteria:

Patients who are unwilling or unable to sign the informed consent Pregnant women
Impact of Pelvic Floor Musculature on Peripartum Outcomes

The purpose of this study is to understand the effect of the pregnancy on the muscles in the pelvis. The purpose of this study is to evaluate the pelvic muscle changes related to pregnancy; to assess if the ability to squeeze and relax these muscles has any effect on delivery mode and if there are any injuries to the pelvic muscles.

Healthy women who are pregnant with their first child will be included in the study. Information about their general health will be gathered. These women will be screened for pelvic disorders at the start and end of study. Three-dimensional ultrasound will be performed three times: 12-24 weeks, 34-39 weeks and 4-6 weeks after delivery. Fetal measurements will be included in the third trimester ultrasound for prediction of estimated birth weight. The relationship of the predicted fetal weight and the likelihood of having a successful vaginal delivery will be studied. Images will be analyzed for pelvic muscles function and injuries. Information regarding the length of labor, types of delivery and vaginal tears will be gathered. The information obtained will be analyzed to look for the strength of correlation of variables to the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous or should not have given birth to a fetus older than 12 weeks.
* Singleton pregnancy.
* Age more than or equal to 18 years.
* Basal mass index between 18 - 40 kg/m2.
* Must plan to deliver at Strong Memorial Hospital at the University of Rochester Medical Center.

Exclusion Criteria:

* Basal mass index more than 40 kg/m2.
* Presence of current or prior history of cervical incompetence.
* Presence of diabetes mellitus (type I or type II).
* Presence of connective-tissue disorders such as Systemic lupus erythematosus, Rheumatoid Arthritis, or Sjogren's disease.
* Presence of neuromuscular disorders such as myasthenia gravis and neuropathies.