cyrilzakka/clinical-trials huggingface dataset:
The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy

Cervical anastomotic leak is one of the most common complications after trans-hiatal esophagectomy.

Hypothesis: An early post operative administration of a pro-kinetic dosage of erythromycin will reduce leak occurrence.

Design: This is a prospective, randomized, double blind, placebo controlled study.

Number of patients: 30.

Inclusion Criteria:

* Patients after trans-hiatal esophagectomy

Exclusion Criteria:

* Allergy to erythromycin
* Use of phenothiazine
* QT prolongation
* Liver function test (LFT) abnormalities
* Myasthenia gravis
* Cardiomyopathy


Eligibility Criteria:
Inclusion Criteria:

* Patients after trans-hiatal esophagectomy

Exclusion Criteria:

* Allergy to erythromycin
* Use of phenothiazine
* QT prolongation
* Liver function test (LFT) abnormalities
* Myasthenia gravis
* Cardiomyopathy
Electrocoagulation Employment During TAPP Inguinal Hernia Repair

Laparoscopic TAPP (transabdominal preperitoneal) hernia repair presents a minimally invasive surgical procedure, which tends to be a gold standard in a wide range of inguinal hernia operations. Postoperative neuralgia is a troublesome complication following TAPP, which occurs in 0.2-7% of patients. The most common cause of nerve injury is an inappropriate use of electrocoagulation or dangerous tissue dissection during TAPP. However, the association between electrocoagulation employment during TAPP and postoperative neuralgia has not been investigated properly until now.

The aim of the project is to compare postoperative pain (postoperative neuralgia) in patients undergoing TAPP inguinal hernia repair with/without the use of electrocoagulation.

Worldwide, more than 20 million patients undergo inguinal hernia repair annually. Laparoscopic hernia repair presents a minimally invasive surgical procedure, which tends to be a gold standard for inguinal hernia repair. In comparison with open techniques of hernia repair, TAPP approach requires a totally different anatomic point of view. The operating surgeon must understand the basic principles and technical key points of TAPP in order to ensure satisfactory surgical outcomes and to prevent the occurrence of complications.

Postoperative neuralgia presents a troublesome complication following TAPP, which occurs in 0.2-7% of patients. Neuralgia is caused by intraoperative injury of genitofemoral, ilioinguinal, iliohypogastric or cutaneous femoris lateralis nerves (genitofemoral nerve being is the most often damaged). During TAPP, the most frequent causes of neural injury include clip application, inappropriate use of electrocoagulation or dangerous tissue dissection. At present, the employment of modern self-gripping meshes and tissue glues leave the use of electrocoagulation the main risk factor for potential nerve injury.

The aim of the proposed project is to evaluate postoperative pain (postoperative neuralgia) in patients undergoing TAPP inguinal hernia repair with/without the use of electrocoagulation. The assessment of the pain in the groin region will be performed on the 2nd and 7th postoperative day by means of clinical examination and by fulfilling the visual scale of pain. In patients showing clinical signs of postoperative neuralgia on the 7th postoperative day, clinical examination by an experienced neurologist will be performed.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* unilateral inguinal hernia
* no previous intraabdominal operations
* no history of neurological diseases

Exclusion Criteria:

* recurrent inguinal hernia
* bilateral inguinal hernia
* history of chronic pain syndrome
* preoperative ASA classification IV-V
Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion

Intrauterine adhesion (IUA) is the adhesion of intrauterine tissues due to the exposure of myometrial tissues caused by the endometrial basal injury. IUA is clinically manifested as symptoms such as abdominal pain, hypomenorrhea or amenorrhea, sterility and habitual abortion, which seriously affect the patients quality of life.

Preventing IUA has been tried using different methods such as barrier or stent in order to separate the opposing endometrium during the tissue healing processes. Although some successes have been reported there are still some challenges need to be dealt with.

One of the barrier materials for preventing IUA is made of hyaluronic acid (HA). HA is a natural ECM of human tissue with excellent biocompatibility and promotes the scar-free wound repair. The self-crosslinked esterified HA gel has demonstrated the capacity to prevent IUA in clinical studies.

A novel self-crosslinked HA gel is developed by BioRegen Biomedical（Changzhou）Co., Ltd with proprietary technologies. This product is a highly viscoelastic crosslinked gel that overcomes the shortcoming of sodium hyaluronate with high motility and too quick degradation in vivo. For this product, the results of animal experiments and various safety features have been designed and tested conforming to the national regulations and standards. In order to launch this product to the market, this prospective, randomized and controlled clinical trial is designed and will be performed to verify its safety/efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Female patients who are 20-40 years old who is diagnosed as intrauterine adhesion, and did not receive adhesiolysis surgery.
* Patients who signed the informed consent form (ICF) and agreed to take contraceptive measures within 3 months after the surgery.
* Physical examination and routine laboratory tests demonstrated no systemic diseases.
* According to the AFS scoring system on the IUA (1988) only those patients with moderate to severe IUA (i.e. total AFS score larger than 4 points) were enrolled in this clinical trial.

Exclusion Criteria:

* Patients who is allergic to hyaluronan or its derivatives.
* Patients with inflammation of reproductive organs, pelvic cavity inflammation, malignant tumor of reproductive organs and other systemic diseases that could cause metrorrhagia.
* Patients with malformation of reproductive organs.
* Patients who may not take effective contraceptive measures within 3 months after the surgery. Patients who were suffering severe systemic diseases such as coagulative disorders, cardiovascular diseases and long-term alcoholism and drug abuse were also excluded from this clinical trial.
Pilot Study on Focal Prostate Radio-Frequency Ablation

This is a prospective pilot study. The purpose of this research study is to evaluate the safety and efficacy of focal Radio-Frequency Ablation (RFA) in men with low-risk, clinically localized prostate cancer.

RFA is a minimally invasive procedure. It is an image-guided technique that heats and destroys cancer cells. In RFA, imaging techniques such as ultrasound or magnetic resonance imaging (MRI) are used to help guide a needle electrode into a cancerous tumor. High-frequency electrical currents are then passed through the electrode, destroying the cancer cells. Use of an RFA device was approved by the Food and Drug Association (FDA) in 1997 for the purposes of treating soft tissue tumors. The device we (Moffitt Cancer Center) will be using in this study has clearance for clinical use from the FDA. The effectiveness of the device is measured using biopsy cores at the site of the cancer after the RFA procedure. To evaluate the benefits of this procedure, we will also evaluate the change in quality-of-life indicators from baseline to 6 months following RFA. RFA is being developed as a minimally invasive potential treatment for prostate cancer.

This research study is a pilot clinical trial. Pilot clinical trials are smaller versions of larger studies that are conducted to prepare for the larger study. This pilot study pre-tests a research device before a large-scale multicenter study is launched.

The specific purpose of this pilot trial is to find out if RFA can effectively treat prostate cancer with fewer side effects including effects on urination, bowel function, and sexual function. RFA for early stage prostate cancer is designed to affect only the part of the prostate where cancer has been detected. The reasoning for this approach is the smaller the area given RFA, the less damage to surrounding tissues.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center review
* No prior treatment for prostate cancer including hormonal therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Prostate Cancer Clinical Stage T1c
* prostate-specific antigen (PSA) \<10 ng/ml (this will be the PSA level prompting the initial prostate biopsy)
* Prostate size \<60 cc on transrectal ultrasound
* If on anti-coagulation medications, must be able to suspend this therapy for a couple of weeks
* Adequate organ function Pre-enrollment biopsy parameters (as per H.L. Moffitt Cancer Center review)
* Minimum of 10 biopsy cores
* No biopsy Gleason grade 4 or 5
* Unilateral cancer (only right-sided or left-sided, not bilateral)
* No more than 50% cancer in any one biopsy core
* No more than 25% of cores containing cancer

Exclusion Criteria:

* Medically unfit for anesthesia
* Histology other than adenocarcinoma
* Biopsy does not meet inclusion criteria
* Men who have received any hormonal manipulation (antiandrogens; luteinizing hormone-releasing hormone (LHRH) agonist; 5-alpha-reductase inhibitors) within the previous 6 months
The Test of Those Managing Pain With Their Own Pain

The study aims primarily to investigate physicians' awareness of their health status, empathy towards patients, and management processes through a questionnaire targeting physicians who diagnose and manage patients' pain.


Eligibility Criteria:
Inclusion Criteria:

* Specialist physicians actively working in pain treatment and management (e.g., Algology, Physical Medicine and Rehabilitation, Anesthesiology, Neurology, Rheumatology, etc.) or physicians currently undergoing specialty training in these areas.
* Physicians who volunteer to participate in the study and sign the informed consent form.
* Physicians who have actively followed up patients and applied pain management techniques within the last year.

Exclusion Criteria:

* Physicians who are not actively involved in pain management or who specialize in different medical fields.
* Physicians who do not wish to complete the questionnaire or do not provide voluntary consent.
* Physicians who complete the questionnaire incompletely or invalidly during the study.
Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients

Determine P-glycoprotein expression in blood samples of Acute Lymphocytic leukemia (ALL) pediatric patients receiving MTX treatment and trace its ontogeny and compare it with its expression in pediatric healthy subjects. In addition, to determine the correlation of P-glycoprotein expression and Methotrexate concentration at steady state.

The 20 leukemic patients will be classified into three age groups according to the ages that will be available at the time of sample collection.

* All patients will be recruited from Tanta Oncology Center, Tanta University.
* The study will be approved by the Research Ethics Committee of Tanta University and college of Pharmacy ethical committee.
* An informed consent will be obtained from parents of all patients in this research before enrollment.
* All patients' data will be private and confidential. Any unexpected risks that may appear during the course of the research will be reported to patients and the ethical committee on time.

Blood Samples will be obtained from healthy pediatric subjects of the same ages of the diseased group subjects (Samples will be obtained from subjects from a primary care center during their routine blood analysis excluding patients of chronic diseases, patients receiving any medications, and patients of impaired kidney or liver functions).

P-glycoprotein expression will be estimated in all samples using Permeability glycoprotein (P-gp), ELISA Kit, and its expression will be traced with development from the youngest till the oldest age available, this will also be compared with normal healthy pediatric subjects.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric Acute Lymphocytic Leukemia Patients
* aged \< 18 years old
* who are already taking the ALL MTX protocol.

Exclusion Criteria:

* Severe renal impairment (eGFR\< 30 mL/min/1.73 m2 at screening)

  * Critically ill patients.
  * Other types of cancer
Transition of Care for Patients With Hirschsprung Disease and Anorectal Malformations

Transition from paediatric to adult health care is crucial for preventing deterioration of chronic diseases. At present, transitional care (TC) is not established for patients with the Hirschsprung disease (H) and Anorectal Malformations (ARM). To set up a program for TC and to treat persisting symptoms in adults, data on outcome in adult patients are needed. At present such data are very limited. Therefore, we want to investigate clinical and PROM in H and ARM adolescents and adults. A cross sectional study in all H and ARM patients operated in Norway from 1970-2000 and in all adolescents operated at Oslo University Hospital from 2002-2006 will examine somatic, psychosocial and mental health, and quality of life (QoL). In children operated for H and ARM a large body of evidence shows that bowel problems, reduced QoL and impaired psychosocial and mental health are common. There are papers on sexual and urological impairment in these patients, but large studies on the topic is missing. It is a general assumption among paediatric surgeons that both somatic and mental health problems related to H and ARM improve during adolescence and adult life. Therefore, no standardized guidelines for TC in these patients have been established. Interestingly, very few studies have actually examined H and ARM patients beyond adolescence. Reports from patient organizations showing significant long-term sequels and inadequate understanding of the unique problems of H and ARM patients among health professionals treating adults. Hypothesis:H and ARM adults and adolescents have bowel, urinary and sexual difficulties and reduced QoL, psychosocial and mental health. H and ARM adults receive insufficient treatment of their chronic congenital disease. H and ARM patients with syndromes have particularly bad functional outcome. Anal dilatations and repeated rectal enemas have a negative impact on adolescent psychosocial and mental health. Main aim: Acquire knowledge about long-term bowel, urinary and sexual function, QoL and psychosocial and mental health in adult and adolescent H and ARM patients. Results: from this large study of H and ARM patients will have significant influence on treatment and follow-up, both nationally and internationally. Since very few countries except the Nordic countries have the possibility to follow patients with congenital malformations into adulthood, it is important that studies like this are done.


Eligibility Criteria:
Inclusion Criteria:

Alle patients with Hirschsprung and anorectal malformation

Exclusion Criteria:

None
Inpatient Attending Physician Rotation Duration Study

The investigators are testing the effects of a change in teaching attending physicians' rotations (from 4- to 2-week blocks) on patient outcomes (unplanned urgent visits to the health care system, inpatient mortality, and length-of-stay), the educational experiences of residents and medical students and on the quality of the professional lives of the attending physicians.

Design, Setting, and Participants Cluster randomized crossover noninferiority trial, with attending physicians as the unit of crossover randomization and 4-week rotations as the active control, conducted in a US university-affiliated teaching hospital in academic year 2009. Participants were 62 attending physicians who staffed at least 6 weeks of inpatient service, the 8892 unique patients whom they discharged, and the 147 house staff and 229 medical students who evaluated their performance.

Intervention Assignment to random sequences of 2- and 4-week rotations.

Main Outcome Measures Primary outcome was 30-day unplanned revisits (visits to the hospital's emergency department or urgent ambulatory clinic, unplanned readmissions, and direct transfers from neighboring hospitals) for patients discharged from 2- vs 4-week within-attending-physician rotations. Noninferiority margin was a 2% increase (odds ratio \[OR\] of 1.13) in 30-day unplanned patient revisits. Secondary outcomes were length of stay; trainee evaluations of attending physicians; and attending physician reports of burnout, stress, and workplace control.

Eligibility Criteria:
Inclusion Criteria:

* Attending physician on inpatient general medicine wards of Stroger Hospital, Chicago, IL

Exclusion Criteria:

* Scheduled for less than 6 weeks during the 2009 academic year
Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization.

This is a prospective, double-blinded, randomized, multi-centre, cross-over study. All subjects will use both the study device (test catheter) and the comparator (control catheter) for one week each.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent.
* Males, aged 18 years and over.
* Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.).
* Practice CIC at least 2 times daily.
* Using catheters in the size CH 12 or CH 14, Nelaton tip, and able to use catheter length of 40 cm.
* Experienced users of CIC defined as a minimum of three months on therapy.
* Adults able to read, write and understand information given to them regarding the study.

Exclusion Criteria:

* Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥103 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection.
* Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters.
* Involvement in the planning and conduct of the study (applies to both WHC staff and staff at the study site).
* Previous enrolment or randomisation of treatment in the present study.
* Simultaneous participation in another clinical study that may impact the primary endpoint.
* Severe non-compliance to protocol as judged by the investigator
Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian or primary peritoneal cancer.

OBJECTIVES: I. Determine the safety and tolerability of intraperitoneal administration of paclitaxel (Paclimer microspheres) in patients with recurrent or persistent ovarian or primary peritoneal carcinoma. II. Determine and confirm the maximum tolerated dose of this regimen in this patient population. III. Determine plasma paclitaxel concentrations at selected times after intraperitoneal administration of Paclimer microspheres in these patients.

OUTLINE: This is a dose escalation study. Patients receive intraperitoneal paclitaxel (Paclimer microspheres) every 8 weeks for 2 courses. Cohorts of 1-3 patients receive escalating doses of intraperitoneal paclitaxel (Paclimer microspheres) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities. Once the probable MTD is determined, an additional cohort of 8 patients is accrued to confirm the MTD. The MTD is confirmed as the dose level at which at least 6 of 8 patients demonstrate acceptable safety and tolerability.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Recurrent or persistent ovarian and/or primary peritoneal carcinoma Adequate potential intraperitoneal fluid distribution with no gross fluid loculations and adhesions that would significantly affect intraperitoneal drug distribution

PATIENT CHARACTERISTICS: Age: 21 and over Performance status: GOG 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Other: No other sufficiently severe medical problems unrelated to malignancy that would preclude study compliance or cause exposure to undue risks No prior unmanageable reaction to paclitaxel

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea and mitomycin) and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to major bone marrow containing areas Surgery: Not specified Other: At least 1 month since other prior investigational agents
Extracorporeal Shockwave Therapy in Long-term Functional Outcomes of Shoulder Adhesive Capsulitis

Adhesive capsulitis refers to the occurrence of pain and a gradual decline in the range of motion (ROM) due to slow increases in synovial hypertrophy and the adhesion between the synovial membrane and articular surface. It leads to the loss of flexibility and difficulties with the activities of daily living (ADLs) due to chronic inflammation accompanied by intra-articular fibrosis. The real cause of this syndrome is unknown but there are some predisposing factors involved such as synovial cell hyperplasia, fibrosis of the capsule due to cytokines or other inflammatory factors. In the current study investigator will compare the effects of Extracorporeal Shockwave Therapy (ESWT) along with conventional therapy to treat the adhesive capsulitis.

This study will be a Randomized Controlled Trail conducted at Horizon hospital, Lahore. The study will be completed within the time duration of Six months. Consecutive sampling technique will be used to collect the data. The sample size of 44 patients will be taken in this study to find the effects of ESWT on pain, ROM, functional mobility. Patient will be divided into two groups. Group A will be treated with ESWT with conventional therapy and Group B will be treated with conventional therapy. Constant Shoulder Score (CSS) and the Oxford Shoulder Score (OSS) tools will be used to measure the outcomes of the study.

One session of treatment per week for four weeks will be given. Pretest, posttest at 4th week and followup of 24th weeks will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed or episode of pain score ≥5 at assessment with a past history of pain for at least 2 months.
* ROM restriction (\>75% ROM loss in ≥2 directions including abduction, flexion and external rotation)
* No treatment other than analgesics with unresponsive ROM restriction for the past 2months.
* Unwilling or waiting and did not undergo joint injection.

Exclusion Criteria:

* bilateral shoulder involvement
* History of previous surgery on the shoulder
* Shoulder fracture
* Cancer
* Glenohumeral or Acromioclavicular arthritis
* Inflammatory disorders
* Bleeding disorders
* Diabetes mellitus
* Presence of severe osteoporosis
* Pulmonary diseases
* Any neuromuscular disorders
* Pregnancy
* Implanted pacemaker