cyrilzakka/clinical-trials huggingface dataset:
Open Appendectomy Versus Laparoscopic Appendectomy

1. Laparoscopic appendectomy may not be a superior procedure when compared with open appendectomy; 2. Various modifications in laparoscopic appendectomy procedure may reduce the technical diffuculty and overall costs.

The study will be a prospective randomized clinical trial. Totally 150 patients who are diagnosed to have acute appendicitis will be randomly divided into 3 equal groups (n=50 for each group). First group will have traditional open appendectomy procedure; second group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by metal endoclips; and third group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by intracorporeal suture ligation. The preoperative parameters that will be obtained for all patients are: detailed information for communication, patient history, age, gender, the presence of spesific symptoms (nausea, vomiting, loss of appetite, right lower quadrant pain), the presence of clinical signs, laboratory findings, and radiological findings. The peroperative parameters that will be recorded are: operative time, the type and the length of incisions, the number of trocars, operative findings, details of laparoscopic technique, generic name of prophylactic antibiotic, and the presence of additional findings. All of the patients will undergo a clinical evaluation by attending surgeon on the 5th, the 15th, and the 30th postoperative day. The postoperative clinical evaluation will include the examination of the patient for surgical site infection and other wound complications, and the performance of a spesific quality-of-life index questionnaire. In the end of the study, all parameters and quality-of-life scores will undergo statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* The patients with a preoperative diagnosis of acute appendicitis

Exclusion Criteria:

* The patients who are not volunteered to join the study
* The patients who are diagnosed to have peroperative or histopathological pathology other than acute appendicitis
* The patients who have additional pathologies accompanying acute appendicitis
Arabin Pessary in Singleton Pregnancy

This was a retrospective study sharing the experience of women high risk for spontaneous preterm birth managed by Arabin pessary.

The study recruitment was from 1st January 2013 until 31st December 2019. Inclusion criteria were previous mid-trimester miscarriage and/or preterm birth, previous cervical surgery or short cervical length on routine ultrasound. The primary outcome measure was birth before 34 weeks gestation.

Eligibility Criteria:
Inclusion Criteria:

* all women high risk for spontaneous preterm birth

Exclusion Criteria:

* had Arabin insertion elsewhere
* delivered elsewhere
* incomplete record
Effect of dRAST on Treatment for Bacteremia in Patients With Hematologic Diseases

The purpose of this study is to evaluate whether the use of direct rapid antibiotic susceptibility test (dRAST), in addition to the current standard antibiotic susceptibility test, can increase the proportion of patients with hematologic disease who received appropriate antibiotics in early period of bacteremia.

* patients with hematologic diseases who have high risk of bacteremia, because of immune suppression treatment or intensive chemotherapy or bone marrow transplantation which these patients had received, will be recruited in tertiary referral medical centers.
* All the participants will be randomly assigned into either dRAST group or current standard antibiotic susceptibility test group.
* All the participants in the both arms will receive antimicrobial stewardship by infectious disease specialists. Antimicrobial stewardship will be performed at each timepoint of Gram stain results reporting, dRAST results reporting, and current method reporting.
* Target numbers are 58 and 58, respectively.
* All the participants will be monitored for general medical conditions such as vital sign and response to antibiotic treatment by infectious disease specialists for 1 week.
* The percentage of patients who received optimal targeted antibiotics 72 hours after blood collection for blood culture will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are expected to be admitted for more than 2 days due to treatment or complications of hematologic diseases (acute leukemia, chronic leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, aplastic anemia, etc.) in Seoul National University Hospital.
* Patients with confirmed bacteremia
* Patients who can understand the details of the clinical trial's explanation and provide the written consent

Exclusion Criteria:

* Patients who are expected to stay in the hospital within 2 days
* Patients without bacteremia during hospitalization
* Patients who show fungemia without evidence of bacteremia
Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP

The primary purpose of this study is to evaluate the safety of multiple doses of Staphylococcal protein A (PRTX-100) in adult patients with Idiopathic Thrombocytopenia Purpura (ITP). The pharmacokinetics, immunogenicity and pharmacodynamics will also be studied.

Patients will be enrolled into 1 of 3 dose groups and receive 4 weekly IV doses of PRTX-100. A Safety Monitoring Committee will review safety data through Day 28 for the first 5 patients in a dose group before escalation to the next higher dose level. Patients will be followed for 8 weeks after dosing for safety, PK, immunogenicity and effect on platelet count(pharmacodynamics).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic ITP \> 4 months
* Mean platelet count \<50 x 10\^9/L for patients not receiving corticosteroids; or mean platelet count \>=50 x 10\^9/L for patients receiving stable dose of corticosteroids

Exclusion Criteria:

* Splenectomy within 45 days of screening
* Rituximab within 6 months prior to screening
* Cyclophosphamide, vincristine, or any other non-monoclonal antibody treatment for ITP within 3 months prior to screening
* IVIG, WinRho or other anti-RhD within 30 days prior to screening
Genes and Environment in Multiple Sclerosis

The purpose of the research study is to identify the genetic, environmental and immune profiles that may increase a person's risk of developing multiple sclerosis (MS). While MS is not a disease caused by a single variation in genetic material (DNA), a single environmental factor, or a single malfunction in immune cells, there are genetic alterations, environmental exposures and immunologic factors that make the development of MS more likely. Obtaining information about who is at risk for MS will be beneficial in the future if the investigators can identify effective ways to prevent or slow down the progression of this disease.

MS is an autoimmune disease in which the immune system (white bloods cells that normally fight infection) becomes misdirected and attacks healthy tissue. In patients with MS, the misdirected white blood cells attack myelin, a lining that insulates the nerves found in the brain and spinal cord. This results in inflammation and damage in the myelin. Loss of this protective lining disrupts nerve impulses and causes abnormal function in the nervous system.

This large research study will ultimately enroll 5000 subjects who are at risk of developing MS.

Eligibility Criteria:
Inclusion Criteria:

* First Degree Relatives of Patients with MS, or
* Patients who have received anti-TNFa therapy as treatment for inflammatory diseases other than MS such as Crohn's disease, psoriasis and rheumatoid arthritis, or
* Patients that have been referred for an evaluation of first presentation of neurologic symptoms but do not have a diagnosis of MS
* Live in the United States

Exclusion Criteria:

* Does not match any of the inclusion criteria
Evaluation of the Renal Function in an Ultra-endurance Race.

During ultra endurance events, athletes experience extreme physical and mental demands, sometimes at the limits of the adaptive response to human physiology. This is particularly true for the renal function, and some evidence for acute renal failure has already been shown, sometimes leading to dialysis. However, the precise mechanisms involved in acute renal failure in such ultra endurance races are not clearly elucidated.

The aim of our study is to estimate glomerular filtration rate from serum and urinary creatinine and cystitin C at the beginning and at the end of a 110 km ultra endurance race. Our hypothesis is that during the ultra endurance race, renal function may be injured, with a risk for the athlete.


Eligibility Criteria:
Inclusion Criteria:

* Age: At least 20 years old
* Athlete that is officially registered to the 110 km race (INFERNAL Trail des Vosges)
* Athlete informed by a member (MD) of the Medical Staff of the race.
* Athlete that gives and signes the informed consent to the research protocol

Exclusion Criteria:

* Athlete with a known disease that needs the following medications:
* Medications influencing the renin-angiotensin-aldosteron system (angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, aldosteron receptor blockers)
* Diuretic drugs
* Anticoagulant drugs
* Non-steroidal anti-inflammatory drugs
* Athlete with a known thyroid disease (because of the influence on the serum cystatin level)
* Athlete with a know renal disease
* Athlete with a know inflammatory disease
The Use of Earplugs on Temporomandibular Joint

The term temporomandibular joint disorder (TMD) refers to a group of disorders affecting the temporomandibular joint and/or muscles of mastication. Typical symptoms are; joint noises, pain, and limited mouth opening. Many therapeutic modalities have been advocated for the treatment of TMD as intraoral splints, laser, ultrasound, physical therapy, surgery, and medications with inconsistent reported results due to the multifactorial etiology of this disorder. Although intraoral splints are the most widely used therapy, it has some drawbacks as being inconvenient for the patient due to their relatively large size interferes with eating and affects speech, therefore their use is mostly limited to sleeping time, which decreases its effectiveness.

Recently some commercial earplugs that claim to treat TMD have been introduced, however, there is no validated data regarding these appliances. Thus, this study aimss to evaluate the possible effect of earplugs on myogenous TMD.


Eligibility Criteria:
Inclusion Criteria:

* Pain in masticatory muscles for at least 3 months according to the DC/TMD
* Having a stable medication regimen for at least 1 month
* Age of 18-65 years
* Minimum pain intensity of 50 mm on a 100 mm visual analog scale (VAS)
* No concomitant systemic disease
* Natural posterior occlusion.

Exclusion Criteria:

* Undergoing physical therapy
* Using muscle relaxants and/or NSAIDs
* Previous TMD treatment more recently than one year
* Major psychosocial problems
* Undergoing orthodontic treatment
* Wearing removable prosthesis
* Pregnancy
* History of facial trauma.
The Cancer Home Life Intervention Study. A Randomised, Controlled Multicentre Trial and a Health Economic Evaluation

The purpose of this study is to examine the effectiveness and cost-effectiveness of the Cancer Home Life Intervention compared to usual care on performance of and participation in everyday activities and quality of life in people with advanced cancer living at home.

The sample size is based on the primary outcome measure: the mean Activty of Daily Living (ADL) motor ability 1.04 logits (SD 0.727) as measured by the Assessment of Motor and Process Skills (AMPS). A significance level of 0.05 would provide 80% power to detect a between-group difference of 0.3 logits requiring a sample size of N=184. An expected drop-out rate of 32% at 3 months follow-up means that 272 patients with advanced cancer must be included in the study from three hospitals.

Multiple imputation will be used to estimate a plausible value for missing data of participants that are lost to follow-up due to other reasons than death. This does not, however, apply to the primary outcome data where no estimations will be computed.

For normally distributed ratio data the intervention group will be compared with the control group using multiple linear regression analysis of mean changes from baseline. Logistic regression analysis will be used for ordinal data. Adjustments for hospital and for baseline values will be made. A modified intention-to-treat analysis will be applied. Subgroup analyses to identifiy groups that especially benefit from the intervetnion will be performed.

The cost-effectiveness analysis wil be performed with ADL motor ability as the clinical parameter, and the cost-utility analysis will be based on the calculation of Quality Adjusted Life Years (QALY). The Incremental Cost-effectiveness Ratio (ICER) will be calculated and the results summarised in a cost-effectiveness acceptability curve (CEAC).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Diagnosed with cancer
* Evaluated incurable by responsible oncologist in respective out-patient unit
* Functional level 1-2 on the WHO performance scale
* Live within a radius of maximum 60 km from AUH or NH or on the island of Funen
* Live in a private home or in sheltered living
* Know sufficient Danish to fill out questionnaires and participate in interviews.

Exclusion Criteria:

* Cognitive impairment preventing the participants from participating in a structured interview
* Live in a nursing home or a hospice
* Considered incapable of complying with the trial
Efficacy Test on Skin Hydration and Skin Barrier Function

The effects of topically applied pyridoxine tri-isopalmitate (P-IP) which stimulates filaggrin synthesis in keratinocytes, on skin hydration and barrier function were examined. Subjects were separated into two groups to examine the effect of P-IP. Subjects were treated with P-IP formulation on one side of the face and with a placebo formulation on the other side twice daily (morning and evening) for 28 days. All subjects gave written informed consent prior to the study. The skin hydration and TEWL (transepidermal water loss) were evaluated by measuring skin surface conductance with a skin hygrometer SKICON 200EX (I.B.S. ltd., Japan) and TEWL meter AS-CT1 (ASAHI BIOMED, Tokyo, Japan), respectively.

It is expected that the long-term application of P-IP increase skin surface water contents and suppress TEWL.

Eligibility Criteria:
Inclusion Criteria:

* healthy skin

Exclusion Criteria:

* don't use any moisturizer
Acoustic Liver Biopsy in Normals and in Patients With Cirrhosis Using Endoscopic Ultrasound

The purpose of this study is to determine the amount of fibrosis in the liver of hepatitis C patients with advanced fibrosis, using endoscopic ultrasound.

Background: Transabdominal ultrasound cannot be used to quantitate fibrosis in patients with cirrhosis due to variability in the abdominal wall thickness and composition. This variability can be eliminated by using endoscopic ultrasound.

Aim: To determine the amount of fibrosis in the liver of hepatitis C patients with advanced fibrosis, using endoscopic ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* hepatic cirrhosis and hepatitis C and undergoing endoscopy
* Alcoholic liver and undergoing endoscopy
* Normal liver undergoing endoscopy

Exclusion Criteria:

* pregnancy
* Children
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease

Lyme disease is the most common tick-borne disease in the United States. It is caused by the spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1) active infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of co-infection with another organism transmitted by Ixodes ticks. The purpose of this study is to determine the safety and effectiveness, for seropositive patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).

One hundred ninety-four (194) patients will be enrolled in this study. Each patient will be assigned to one of two groups and will be randomly selected to receive either antibiotic therapy or placebo; but, the assignment of medication will not be made known to the patient or administering doctor. Antibiotic or placebo will be given intravenously (IV) for 30 consecutive days and then orally for the next 60 consecutive days.

Eligibility Criteria:
Inclusion Criteria:

You may be eligible for this study if you:

* Are 18 years of age or older.
* Are seropositive for antibodies against B. burgdorferi antigens by Western Blot at enrollment.
* Have documented history of acute Lyme disease.
* Have had a rash (erythema migrans) that resembles a bullseye. This skin aberration usually occurs after a tick bite in late spring, summer or early fall and is sometimes accompanied by fatigue, fever, headache, mild stiff neck, arthralgia or myalgia.
* Have had one or more clinical features typical of Lyme disease acquired in the United States (see technical summary).
* Have had one or more of the following symptoms and conditions that have persisted for at least 6 months (but less than 12 years) and are not attributable to another cause or condition: a) widespread musculoskeletal pain and fatigue that began coincident with or within 6 months following initial infection with B. burgdorferi. b) certain neurologic symptoms including memory impairment and nerve pain within 6 months following initial infection with B. burgdorferi.
* Have had a physician-documented history of prior antibiotic treatment with a currently recommended antibiotic regimen.

Exclusion Criteria:

You will not be eligible for this study if you:

* Have previously enrolled in this study.
* Are pregnant, lactating, or unable to use birth control measures during the treatment period of this study.
* Are taking chronic medication that could interfere with evaluation of symptoms.
* Are taking or have taken various medications that could interfere with the evaluation of symptoms (see technical summary).
* Are hypersensitive to ceftriaxone or doxycycline.
* Have active inflammatory synovitis.
* Have another disease that could account for symptoms of acute Lyme disease.
* Have another serious disease or an active infection.
* Are unable to tolerate an IV.
* Have tested positive for Borrelia DNA in plasma or cerebrospinal fluid at the time of initial evaluation for study.
Gut Hormones After Meal Ingestion in Males Versus Females

The study hypothesis is that the release of gut hormones is increased proportionally to caloric load in each meal. Three different meals with different meal size will therefore be served and gut hormones determined.

In healthy males and females, meals with 511, 743 and 1034 kcal will be given orally. Samples will be taken during the following 300 min and gut hormones (glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1) will be determined along with insulin and glucagon levels.

Eligibility Criteria:
Inclusion Criteria:

* Healthy status

Exclusion Criteria:

* Diabetes
* Liver disease
* kidney disease
* thyroid disease
Gastrointestinal Biopsychosocial Research Center

This study has been completed. The following is a brief description of the aims, methods, and results of the study:

Previous small studies suggest that chronic proctalgia (chronic recurring pain in the anal canal or rectum), which is also called levator ani syndrome, can be treated with biofeedback to teach relaxation of pelvic floor muscles, or electrogalvanic stimulation (electrical stimulation to relax muscles), or massage of pelvic floor muscles. The aim of this study was to compare the effectiveness of these three treatments, to determine how they work physiologically, and to identify which patients are most likely to benefit.

Methods: Subjects had to meet the diagnostic criteria for chronic proctalgia and to report pain at least once a week. They had to also be free of medical or psychiatric disorders that could explain their chronic proctalgia. Patients qualified to enter the study were separated into two groups based on whether they reported tenderness when the examining physician pressed on the levator ani muscles of the pelvic floor. All 157 patients who were enrolled received 9 sessions of psychological counseling plus biofeedback or electrogalvanic stimulation or massage. The results of treatment were assessed at 1, 3, 6, and 12 months after the end of treatment.


Eligibility Criteria:
Inclusion Criteria: Recurring episodes of pain or aching in the anal canal or rectum for at least 12 weeks in the previous year. Episodes last at least 20 minutes. Pain must occur at least weekly during a 4-week run-in.

Exclusion Criteria: Other medical or psychiatric diagnoses that could explain recurring rectal pain. Daily use of psychotropic medications. Meets diagnostic criteria for irritable bowel syndrome or functional constipation. Screening studies included physical examination by a gastroenterologist, colonoscopy, pelvic ultrasound, and surgical consult in all patients and referral to a gynecologist or urologist if indicated by history.
Endoscopic Findings in Patients With Typical Gastroesophageal Reflux Disease (GERD) Symptoms

Gastroesophageal reflux disease (GERD) is diagnosed on the basis of characteristic reflux symptoms (i.e. troublesome heartburn and/or acid regurgitation). Empirical therapy without diagnostic endoscopy is suggested for those GERD patients presenting without alarm symptoms in Western countries. Whether such "treating instead of testing" strategy should be applied in Asia, an area with higher prevalence of Helicobacter pylori and gastric cancer, remains uninvestigated.

This study amis to investigate upper endoscopic findings of typical acid reflux patients with and without alarm symptoms in Taiwan During the period from May 2008 to December 2009, consecutive adult outpatients, who receive upper endoscopy for characteristic reflux symptoms of heartburn or acid regurgitation, are invited to participate. All study participants are evaluated for presence of pre-defined alarm symptoms including odynophagia or dysphagia, gastrointestinal bleeding, involuntary body weight loss and anemia.

Upper endoscopic procedures are performed with standard electronic videoendoscope (GIF-Q240 or GIF-Q260; Olympus, Tokyo, Japan) by experienced endoscopists; each of them had previously performed a minimum of 2,000 upper endoscopy exams. Representative images are taken and stored as electronic files in a digital image system for later analysis.

The following five significant endoscopic findings are pre-defined endpoints of this study: 1) any malignant lesion in the upper digestive tract, 2) Barrett esophagus, 3) severe erosive esophagitis (LA grade C or D), 4) peptic stricture, 5) peptic ulcer.

Eligibility Criteria:
Inclusion Criteria:

* outpatients
* chief complaints of characteristic GERD symptoms (heart burn or acid regurgitation), evaluated by standard questionnaire
* undergo upper digestive endoscopy

Exclusion Criteria:

* age less than 18 years old or more than 90 years old
* unable to complete upper endoscopy
* known diagnosis of gastroesophageal malignancy
* follow-up visit for known gastroesophageal lesion identified by previous upper endoscopy
* failure to obtain informed consent