cyrilzakka/clinical-trials huggingface dataset:
Spinal Cord Stimulation for Orthostatic Hypotension

This is a prospective single-center randomized crossover control study that aims to evaluate the effects of non-invasive transcutaneous spinal cord stimulation in patients with known or suspected orthostatic hypotension.

The hypothesis is that transcutaneous spinal cord stimulation at thoracic level may correct hypotensive episodes during tilt testing in subjects with blood pressure drops.

Eligible patients will sign an informed consent form before the procedure. Non-invasive transcutaneous electrical stimulation of the spinal cord will be applied using modulated electrical impulses through external adhesive electrode patches connected to a neural stimulator device. The study protocol includes analysis of the following parameters: heart rate; 12-lead electrocardiogram; continuous beat-to-beat blood pressure recordings (measured noninvasively by plethysmography) before stimulation, during stimulation and after spinal cord stimulation. All registered data will be analyzed at the end of the procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-85 years
2. Suspected orthostatic hypotension (having a history of syncope and/or pre-syncope that occurred during the transition to an upright position, with complaints of recurrent dizziness that occurs during the transition to an upright position) or documented orthostatic hypotension.
3. The patient who signed the informed consent form

Exclusion Criteria:

1. Orthostatic hypotension caused by acute hypovolemia or bleeding.
2. Chronic heart failure III-IV functional class (NYHA)
3. Structural heart disease of the following: hypertrophic cardiomyopathy with obstruction of the left ventricular outflow tract, acute coronary syndrome, restrictive cardiomyopathy, hemodynamically significant valvular heart defects, uncorrected hemodynamically significant congenital heart defects.
4. Ongoing acute illness.
5. \>90% paced cardiac rhythm.
6. Permanent atrial fibrillation.
7. A history of transient ischemic attack or stroke within 3 months before the enrollment and/or incomplete recovery.
8. Pulmonary embolism \<1 month ago.
9. Epilepsy.
10. The presence of an implantable pump.
11. Patients with contraindications to the use of the patch electrodes used in this study, as indicated in the relevant instructions for use.
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy

This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is \<3 months, and the planned sample size was 170 patients.


Eligibility Criteria:
Inclusion Criteria:

* males and females 2-16 years of age
* scheduled to undergo elective surgery for tonsillectomy or adenotonsillectomy requiring general anesthesia and endotracheal intubation
* scheduled for hospital admission for no longer than 24 hours

Exclusion Criteria:

* known allergy or other contraindication to the use of Kytril or any of its components
* known allergy to any other 5HT3 antagonist
* history of motion sickness or post-operative nausea or vomiting
* nausea or vomiting in the 24 hours prior to anesthesia
Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer

Phase II trial to study the effectiveness of broxuridine in treating patients who are undergoing surgery for stage I or stage II prostate cancer. Broxuridine may help doctors determine the rate of growth of prostate tumors and help them plan effective treatment

OBJECTIVES:

I. Measure the potential doubling times of multifocal adenocarcinomas of the prostate using broxuridine.

II. Determine whether the doubling times of multifocal carcinomas occurring within a single prostate are consistent with a model in which low-volume carcinomas have slow doubling times and high-volume carcinomas have fast doubling times.

OUTLINE:

Patients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate. Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage I or II (T1-2) carcinoma of the prostate

  * PSA greater than 8 ng/mL
  * Abnormal findings on digital rectal examination
* Eligible for radical prostatectomy
* Performance status - ECOG 0 or 1
* No prior biologic therapy
* No prior chemotherapy
* No prior neoadjuvant hormonal therapy
* No prior radiotherapy
* See Disease Characteristics
* No prior therapy that would affect tumor growth rates or volume
Non-Invasive Brain Stimulation as an Innovative Treatment for Chronic Neglect Patients

Background Stroke is a leading cause of neurological impairments in language, motor and cognitive functions. Next to traditional stroke treatment, Non-Invasive Brain Stimulation (NIBS) offers the potential to facilitate stroke recovery as a complementary approach. Here, we aim at exploiting the principles of NIBS, specifically transcranial Alternating Current Stimulation (tACS), to promote functional recovery of people with neglect symptoms following stroke.

Objective To determine whether neglect training complemented with tACS treatment in chronic stroke patients suffering from neglect improves neglect-related symptoms compared to neglect training with sham stimulation.

Study design Double-blind randomized placebo-controlled intervention study. After enrollment and completion of baseline measurements, participants are randomly assigned to either the active tACS group or sham (control) group.

Intervention We will combine an evidence based visual scanning training (VST) with 40 minutes of (active or sham) tACS at alpha frequency. The intervention is administered three times a week for a duration of six weeks.

Outcomes of the study Performance on standard, conventional neuropsychological tests, as well as on ADL observation scales.


Eligibility Criteria:
Inclusion Criteria:

* neurologically objectified stroke;
* stroke occurred when patient was 18-80 years of age;
* chronic stroke (\>6 months post-stroke onset);
* sufficient comprehension and communication skills to benefit from training (based on clinical judgement); and
* a screening containing four neuropsychological tests will be performed to evaluate the current severity of the neglect, since the diagnosis of neglect may have been established months or even years ago in our sample of chronic stroke patients.

Exclusion Criteria:

* currently engaging in cognitive rehabilitation treatment or neglect treatment;
* physically or mentally unable to participate (based on clinical judgment);
* hemianopsia (based on clinical judgement);
* severe communicative disability, as task descriptions need to be understood;
* local scalp injuries\*;
* eczema on scalp or psoriasis\*;
* diagnosed (neuro)psychiatric or neurodegenerative diseases\*;
* current alcohol and/or drug abuse\*; and
* pregnancy\*.

  * due to tACS safety considerations.
Comparison Of Outcome Of Antibiotic Coated Vicryl Vs Non-Coated Vicryl In Abdominal Fascial Closure After Laparotomy In Children

We are investigating outcome of antibiotic coated vicryl versus non coated vicryl in terms of rate of surgical site infection and lebgth of hospital stay in children after lalaprotomy for perforated viscera. total 100 patients will be taken and 50 in each group.

Pneumoperitoneum is typically a surgical emergency, particularly in children and more than 90% of occurrences are caused by perforation of the gastrointestinal tract and other hollow viscera. Wound infections after abdominal surgery are still frequent types of nosocomial infections. Sutures can be a source of wound infection and dehisence due to bacterial adherence and colonization. Sutures coated with antibacterial agents have been developed in an attempt to reduce bacterial adherence and colonization of suture materials. The objective of the study is to compare the outcome of antibiotic coated vicryl versus non-coated vicryl in abdominal fascial closure after laparotomy in children in regards of surgical site infections. It will be a randomized controlled trial in which 100 patients admitted in Children Hospital Lahore will be included. Simple random sampling will be carried out. Informed written consent will be taken from patients' guardian. The patients will be divided into two groups (50 in each group). Group-A patients will undergo laparotomy closure with antibiotic coated vicryl while Group-B patient will experience non-coated vicryl in abdominal fascial closure. All patients will be examined on 3rd, 7th and 30th post-operative day for wound infection according to Southampton wound scoring system. Data will be collected through predesigned proforma, which will be entered and statistically analyzed using SPSS version 24.0. For quantitative variables mean and standard deviation will be calculated and for qualitative variables frequency and percentages will be calculated. Data will be presented in tables and graphs. Chi-square test will be used to estimate the association between qualitative variables. P-value \<0.05 will be considered significant. It is expected that results of this study may be helpful for healthcare providers to provide appropriate treatment to the patients and to prevent them from wound related complications.

Eligibility Criteria:
Inclusion Criteria:

* • Children with pneumoperitoneum / perforated viscus

  * Children aged 0 day to 15 years
  * Both genders

Exclusion Criteria:

* • Malnourished children

  * Children aged above 15 years
  * Clean surgeries
  * Low Hb level
  * Parents unwilling to take part
Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients

Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. The purpose of this study is to compare propofol to midazolam for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy.

Background : Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. AIM: The purpose of this study is to compare propofol to midazolam for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy. Methods: 60 outpatients who has known chronic liver disease (Child-Pugh class A or B) (cirrhosis) and are undergoing variceal screening will be randomized to receive propofol or midazolam for sedation. Administration of sedation was performed by a anesthesist. Outcome measures studied are induction and recovery times, efficacy and safety of sedation, patient satisfaction, and return to baseline function and subclinical hepatic encephalopathy (number connection test), and saturation of oxygen. expected results: The mean time to achieve adequate sedation will be shorter for for the propofol group in comparison to midazolam group. The level of sedation achieved by the propofol group will be greater. Time to full recovery will be faster in the propofol group. Propofol do not exacerbate subclinical hepatic encephalopathy as compared to midazolam. patients receiving propofol will express greater overall mean satisfaction with the quality of their sedation at the time of discharge. Conclusions: Propofol sedation is expected not to exacerbate subclinical hepatic encephalopathy in cirrhotics.

Eligibility Criteria:
Inclusion Criteria:

* Known chronic liver disease (Child-Pugh class A or B) who presented for upper GI endoscopy for routine variceal screening.
* The diagnosis of liver disease will be based on available past history, serological testing, radiological imaging, and liver histology when available.
* Staging of cirrhosis will be determined by MELD score and by Child-Pugh score . All patients will complete a standard preprocedure history and physical examination to establish current degree of encephalopathy and ascites.

Exclusion Criteria:

* Exclusion criteria will include the following:

  * known allergy or adverse reaction to sedative or component thereof
  * patients with known significant respiratory disease or airway abnormality)
  * active neurological impairment including clinically detectable hepatic encephalopathy
  * advanced or decompensated liver disease ( CP score \>10, MELD \>24) (Child-Pugh class C)
  * active alcohol consumption or illicit drug abuse
  * active prescription for sedation or narcotics
Evaluation of Therapeutic Drug Monitoring of Protease Inhibitors on Virologic Success and Tolerance of Highly Active Antiretroviral Therapy (HAART)

This Cophar2 study is a trial which evaluates repeated early therapeutic drug monitoring, from weeks 2 to 24, after the initiation of HAART including either indinavir/r, lopinavir/r or the new 625 mg formulation of nelfinavir twice-a-day (bid). If trough concentrations were out of the range given for each protease inhibitor (PI), the PI dose was adjusted.

Because of the large pharmacokinetic inter-patient variability of protease inhibitors (PI), therapeutic drug monitoring (TDM) of protease inhibitor (PI) has been proposed to improve efficacy and tolerance of PI-containing HAART. The objective of the Cophar2 trial is to evaluate the feasibility and the impact of an early therapeutic drug monitoring in PI-naive HIV-1 infected patients in order to warrant virological success and safety of HAART.

It is a prospective, open, multicenter trial with repeated early TDM (weeks 2, 8 or 16, 24) after the initiation of HAART including either indinavir/r (IDV), lopinavir/r (LPV) or the new 625 mg formulation of nelfinavir (NFV) bid. It was planned to include 99 PI-naïve HIV-1 infected patients over 18 years old, 33 for each PI. Concentrations were measured by HPLC in each center. If trough concentrations were out of the range of 150-500, 2500-7000 or 1500-5500 ng/ml for IDV, LPV and NFV respectively, the PI doses were adjusted possibly more than once during the first 24 weeks of follow-up. Adjustments were done by steps of one pill (200, 133/33 or 250 mg for IDV, LPV/r or NFV, respectively) bid. Failure of the strategy was defined by either two consecutive viral loads over 200 copies/ml between weeks 16 and 48, or a validated PI-related adverse event grade III or IV or a grade II diarrhoea or renal lithiasis. Patients without adverse events before week 16 were defined as assessable if they had at least the virological assessment of week 16.

Eligibility Criteria:
Inclusion Criteria:

* Patients infected with HIV-1
* Needing an antiretroviral treatment according to standard of care
* HIV viral load greater than 1000 copies/ml
* Beginning a treatment containing a PI (indinavir with or without ritonavir, nelfinavir, lopinavir + ritonavir) and 2 reverse transcriptase inhibitors
* PI-naive
* Antiretroviral treatment-naive or already treated with reverse transcriptase inhibitors but if the viral genotypic test does not show more than 2 major mutations (including T215Y/F, Q151M, M184V/I, V75M/S, L74V) and if 3 nucleoside analogues are still active except for didanosine.

Exclusion Criteria:

* Pregnant women and nursing mothers
* Acute HIV infection
* Diabetes
* Renal insufficiency with creatinine clearance below 30 ml/min
* Cardiac insufficiency
* Hepatic insufficiency with TP below 60%
* Treatment with known interactions with PI
* Chemotherapy against Kaposi's sarcoma, lymphoma, neoplasia
* Treatment containing interferon (INF) or interleukin-2 (IL2) or HIV- immune vaccine
* Treatment with hypolipemic drugs
* Laxative treatment
* Previous renal colic
* Diarrhoea with more than 5 stools/day since one week
RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome

The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.


Eligibility Criteria:
Inclusion criteria Patients with acute coronary syndromes with at least one additional risk factor for cardiovascular complications.

Exclusion criteria

1. Long term treatment with any other oral anticoagulant
2. Severe/disabling stroke within last 6 months
3. Conditions associated with increased bleeding risk
4. Anaemia or thrombocytopenia
5. Severe renal impairment
6. Liver disease
7. Positive pregnancy test
Comparison of the Incidence of Shoulder Pain According to Postoperative Use of Abdominal Binder

The aim of the study is to evaluate the effect of the use of an abdominal binder on postoperative shoulder pain according to laparoscopic gynecological surgery. The investigators will compare the incidences of shoulder pain after laparoscopic gynecological surgery in terms of the use of an abdominal binder.

Laparoscopic surgery has advantages over laparotomy in that it reduces postoperative pain and hospital stay. However, postoperative shoulder pain is one of the major concerns of laparoscopic surgery. Shoulder pain has been reported to occur in 35 to 70% of laparoscopic surgeries. The exact mechanism of shoulder pain after laparoscopic surgery is not clear. The main hypothesis is that the presence of residual carbon dioxide (CO2) in the abdominal cavity stimulates the diaphragmatic nerve and causes pain in the shoulder. Alveolar recruitment maneuver in the Trendelenburg position reduced the intensity and incidence of shoulder pain significantly. However, even with these measures, shoulder pain occurred in 63% of patients after surgery. In addition to this measure, The investigators hypothesized that wearing an abdominal binder would promote the absorption of residual CO2 in the abdominal cavity into the peritoneum and pelvis pressure.

The aim of this study was to evaluate the effect of the use of an abdominal binder on shoulder pain after gynecological laparoscopic surgery.

The intraoperative management is carried out in the same manner, except for wearing an abdominal binder after surgery. Laparoscopic procedure is completed, and then intraperitoneal CO2 is passive drained. An anesthetist places the operating table in the Trendelenburg position at 30 degrees and performs the alveolar recruitment maneuver. (CPAP 45 cm H2O is administered 5 times for 7 seconds) In the abdominal binder group, the patient wears an abdominal binder in the Trendelenburg position and then changed to the supine position before the emergence.

In the control group, the patient placed in the supine position, and emergence is started.

Shoulder pain at 12, 24, and 36 hours after surgery is investigated with a Numeric Score Scale (NRS) score.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 20-79 years with ASA I - III undergoing elective laparoscopic gynecological surgery under general anesthesia

Exclusion Criteria:

* Patients who do not consent to the trial
* Conversion to open surgery from laparoscopic surgery
* Patients with previous shoulder disease or history of shoulder surgery
* Patients who have difficulty wearing an abdominal binder due to skin disease or wounds in the abdomen
* Development of subcutaneous emphysema
* Change of intra-abdominal carbon dioxide pressure due to surgical difficulties
Oral Ketorolac for Pain Relief During IUD Insertion

Ketorolac is a non-steroidal anti-inflammatory drug (NSAID), similar to ibuprofen but it is used to treat more severe pain. Ketorolac (Trade name: Toradol) is typically used after surgical procedures. When taken orally, it should not cause sedation. The purpose of this study is to determine if oral ketorolac is effective at reducing pain during IUD placement versus a placebo tablet.

In the United States, 10% of women choose an intrauterine device (IUD) for contraception. With typical use, unintended pregnancy rates in the first year of IUD contraception are 0.8% (Copper T) and 0.2% (LNG). It is known that long-acting, reversible contraception methods reduce the long-term cost of unintended pregnancies. A common deterrent to intrauterine contraception is the fear of pain during placement. Methods of pain relief during IUD insertion must be fast-acting but have minimal sedation. There have been many attempts to find effective pain relief during IUD placement. Neither ibuprofen nor naproxen have been shown to be effective in reducing pain. Misoprostol has been used to increase cervical ripening; however, pain was not decreased, and side effects of nausea and vomiting were increased. Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that works by reversibly inhibiting cyclooxygenase-1 and 2.Time to peak plasma concentration ketorolac in the oral form is 44 minutes. Studies have shown that one dose of ketorolac can be as potent as morphine. Ketorolac is also well established for pain control in the immediate post-operative period. A recent study showed that intramuscular ketorolac wais effective in reducing pain after IUD insertion, but 20% of the participants reported that after the procedure, the injection site was as painful as the IUD placement. The current study was designed to evaluate if there is reduced pain during IUD placement using oral ketorolac 40-60 minutes before the procedure compared to a placebo.

Eligibility Criteria:
Inclusion Criteria:

* non-pregnant
* English speaking women
* 18 years of age or older desiring an IUD for contraception

Exclusion Criteria:

* enrollment in another study
* pre-medication with any type of analgesic medication
* contraindication to an IUD
* weight under 50 kg
* allergy to non-steroidal anti-inflammatory medications
* past medical history of liver disease, renal disease, peptic ulcer disease or recent gastrointestinal bleed,
* daily narcotic pain use
* positive cultures for gonorrhea or chlamydia.