cyrilzakka/clinical-trials huggingface dataset:
Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride

This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only) Approximately 600 male and female patients presenting moderate to severe pain after an elective primary hip arthroplasty are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.

In this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). Namely:

* DKP/TRAM followed by DKP/TRAM;
* DKP followed by DKP;
* TRAM followed by TRAM;
* placebo followed by DKP;
* placebo followed by TRAM;
* placebo followed by DKP/TRAM;

The analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.

The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 to 80 years. Females participating in the study must be either of non-childbearing potential, or willing to use a highly effective contraceptive method.
* Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to primary osteoarthritis.
* Patients experiencing pain at rest of at least moderate intensity the day after surgery.

Exclusion Criteria:

* Patients not suitable for study treatments and rescue medication (RM) or those for whom non-steroidal anti-inflammatory drugs (NSAIDs), opioids, acetyl salicylic acid, pyrazolones or pyrazolidines are contraindicated.
* Patients with clinically significant abnormalities in vital signs, safety laboratory tests and 12-lead ECG at screening.
* Patients with history of any illness or condition that might pose a risk to the patient or confound the efficacy and safety study results.
* Patients using and not suitable to withdraw analgesics other than those specified in the protocol.
* Patients using and not suitable for withdrawing any of the prohibited medication specified in the protocol.
* Pregnant and breastfeeding women.
Factors Related to a Persistent Inadequate Bowel Preparation for Colonoscopy

Adequate bowel preparation for colonoscopy has an extremely relevant impact on diagnostic yield and procedural success. The guidelines recommend an adequate colon cleansing rate of at least 90% of procedures. It has been shown that patients with inadequate colon cleansing history have a high probability of not reaching an adequate bowel preparation again.

Surprisingly, no evidence-based recommendations are available regarding bowel preparation in the patient with inadequate colon cleansing history. Therefore, identifying the factors associated with repeated inadequacy of bowel cleansing is crucial in order to define the best preparation strategy in this subset of patients. The implications for patients and for healthcare system are many: improving the quality of bowel preparation would reduce the need to repeat colonoscopy and the risk of conducting unreliable examinations. Furthermore, it would reduce the costs for the healthcare system by avoiding to overload endoscopic units.

Inclusion criteria:

Outpatient and hospitalized patients, adults, candidates for colonoscopy for any pathology, as part of the normal care process, with the need to repeat bowel preparation due to inadequate cleansing.

Exclusion criteria:

* Emergency regime
* Inability to obtain consent
* Refusal of the patient

Primary end-point:

Identification of factors independently associated with repeated inadequate colon cleansing after inadequate bowel preparation at previous colonoscopy, and consequent development (and validation) of a predictive model.

The colon cleansing will be evaluated according to the Boston Bowel Preparation Scale (BBPS), which assigns a score from 0 (presence of solid stools) to 3 (excellent visualization of the colonic mucosa) for each of the three main segments of the colon, i.e. right colon, transverse colon and left-rectum colon. Colon cleansing will be judged inadequate in case of a total score \<6 or a score \<2 even in only one of the colic segments.

Secondary end-point:

• Assess the prevalence of repeated inadequate bowel cleansing in the patient with previous inadequate cleansing


Eligibility Criteria:
Inclusion Criteria:

* Outpatients or hospitalized patients
* adults
* candidates for colonoscopy for any pathology, in the normal pathway of care, with the need to repeat the bowel preparation due to inadequate colon cleansing.

Exclusion Criteria:

* Emergency regimen
* Inability to obtain consent
* Patient refusal
Effects of 2 Different Doses of Pantoprazole on Gastric pH and Recurrent Bleeding in Patients Who Bled From Peptic Ulcers

Endoscopic treatment of bleeding peptic ulcers is effective to prevent rebleeding. Adjuvant medical treatment to increase gastric pH may further decrease rebleeding. Recent studies on potent acid suppression by proton pump inhibitors (PPI) demonstrated the efficacy in preventing rebleeding. Lau demonstrated that high dose intravenous infusion of omeprazole decreased rebleeding in peptic ulcers with stigmata of recent hemorrhage.

There is little data regarding the effect of pantoprazole on bleeding peptic ulcers. Furthermore, the optimal dose of PPI is unknown. Few studies have included measurement of gastric pH in addition to clinical outcome.

This study compares the effect of two doses of intravenous pantoprazole with no acid suppression in bleeding peptic ulcers after endoscopic therapy. In addition to the usual clinical endpoints, gastric pH is monitored to study the relation of pH elevation and the clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* patients presenting with upper gastrointestinal bleeding with upper endoscopy showing a bleeding peptic ulcer with major stigmata of haemorrhage and after successful endoscopic haemostasis.

Exclusion Criteria:

* previous gastrectomy and vagotomy
* patient taking warfarin
* intake of anti-secretory drugs in the previous 48 hours
Neurodynamic Sequencing in Patients With Carpal Tunnel Syndrome

Carpal tunnel syndrome is a compressive neuropathy of median nerve in the fascial tunnel at wrist which causes pain, numbness ,and tingling in the extremities. Common treatment options used in the treatment of carpal tunnel syndrome are conservative and surgical treatment option is better, this question is still a topic requiring more and more clinical trials. Neuromobilisation described by Butler is one of the treatment options which are used in the treatment of carpal tunnel syndrome in conjunction with other conservative measures.

This proposed study will find out the effectiveness of Neuromobilisation in treatment of carpal tunnel syndrome. As there is very little evidence available which Neuromobilisation technique is effective and what are the types of patients which can get benefit from this technique. This study will find out the effect of Neuromobilisation in patients suffering from carpal tunnel syndrome of non traumatic origin. This is a randomized clinical trial. Target population is patients suffering from carpal tunnel syndrome of non-traumatic origin. Data will be collected from District Headquarter Hospital Faisalabad. This study will include 56 participants according to the selection criteria. The participants will be randomly divided into two groups through sealed opaque envelop method.

Group A will recruit 28 patients which fulfill the inclusion criteria. These patients will be treated by nerve sequencing proximal to distal in 3 sets of 15 repetitions in one session on alternate days for 4 weeks. Group B will recruit 28 patients which fulfill the inclusion criteria. These patients will be treated by nerve sequencing distal to proximal in 3 sets of 10 repetitions in one session for 4 weeks. The Statistical analysis will be performed through SPSS Software 21.


Eligibility Criteria:
Inclusion Criteria:

* Patients positive for provocative test ( Phalen's test, Wrist decompression test and tinnel test).

Exclusion Criteria:

* Inflammation around the wrist
* Tumor around the wrist
* Rheumatoid Arthritis
* Osteoporosis
* Joint Hypermobility
Total Intravenous Anesthesia in Percutaneous Transhepatic Cholangiography

Percutaneous transhepatic cholangiography is a disturbing procedure for patients.

TIVA with short-acting anesthetics such as propofol and remifentanil is characterized by hemodynamic stability and better compilation profile The purpose of this study; To compare total intravenous anesthesia with inhalation anesthesia in patients undergoing percutaneous transhepatic cholangiography under general anesthesia.

Percutaneous transhepatic cholangiography is a disturbing procedure for patients. Especially pain at the time of dilation can be a serious problem. These situations may be required local anesthetics, intravenous narcotics and sedatives or general anesthesia (1).

TIVA with short-acting anesthetics such as propofol and remifentanil is characterized by hemodynamic stability and better compilation profile (2).

The purpose of this study; To compare total intravenous anesthesia with inhalation anesthesia in patients undergoing percutaneous transhepatic cholangiography under general anesthesia and Determine their advantages and disadvantages.

1. Michael J. Lee, Peter R. Mueller, Sanjay Saini, Peter F. Hahn, Stewen L. Dawson. Percutaneous Dilatation of Benign Biliary Strictures: Single-Season Therapy with General Anesthesia. AJR: 157, December 1991: 1263-1266
2. Xiaoqian Deng, Tao Zhu. Clinical comparison of propofol-remifentanil TCI with sevoflurane induction / maintenance anesthesia in laparoscopic cholecystectomy. Pak J Med Sci 2014 Vol. 30 No. 5: 1017-1021

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing percutaneous transhepatic cholangiography with general anesthesia

Exclusion Criteria:

* Essential data were missing
* Patient participating in other research projects
* Drug allergy
* Anesthetic complication story
Sublingual Misoprostol In Medical Treatment of First Trimester Missed Miscarriage

The aim of this work is to compare the effectiveness of sublingual misoprostol 400 mcg versus 800 mcg for medical treatment of the first trimester missed miscarriage.

the study will be made on female patients with the first trimester missed abortion confirmed by ultrasound. Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol 400 mcg and the other group(B) will receive sublingual Misoprostol 800 mcg every 4 hours in both groups up to 3 doses the aim of the study is to compare the efficacy of sublingual Misoprostol in complete termination of the first trimester missed abortion and which route is the best will less side effects.

Eligibility Criteria:
Inclusion Criteria:

* All women above 18 years of age
* Less than 12 weeks of gestation.
* Pregnancy is confirmed by pregnancy test or ultrasound scan.
* missed abortion
* Normal general and gynecological examination.

Exclusion Criteria:

* Hemodynamically unstable.
* Suspected sepsis with temperature 38 °C.
* Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism,
* respiratory illnesses, recent liver disease, or pruritus of pregnancy.
* Presence of intrauterine contraceptive device (IUCD).
* Suspect or proven ectopic pregnancy.
* Failed medical or surgical evacuation before the presentation.
* Known allergy to misoprostol.
Finger Hardness Measure in Scleroderma

Thirty subjects with systemic sclerosis and 30 age and sex matched controls without any known condition that should cause increased skin hardness in the fingers with undergo examination by manual palpation and durometer measured hardness of their digital tuft skin by 2 observers on 2 separate occasions. There will be 1 hour between individual observer's scorings. Observers will be blinded from the observer's scores and from their previous scores. Results will be tabulated and compared for manual scores versus durometer measurements, intra-observer scores by both methods and inter-observer scores by both methods.

It is pretty straightforward. We will measure and record the hardness of the digital tufts on ten digits by palpation and the hardness in the same area by using a durometer. We will repeat this one hour later. Scores will be compared as a measure of how consistent and precise they are.

Eligibility Criteria:
Inclusion Criteria:

* Scleroderm
* Rheumatologic condition not effecting the skin tightness
Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus ANti-TNF Versus cDMARDs in Real World

This study will be conducted to observe the disease activity change of Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from baseline to 6 months compared with cDMARDs, as measured by the disease activity score with the erythrocyte sedimentation rate (DAS28-ESR).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with rheumatoid arthritis within 3 years
* Participants who have no experience with anti-tumor necrosis factor (anti-TNF)
* Participants who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months prior to informed consent
* Participants who change the treatment regimen to one of the following according to the opinion of the investigator:

  1. One cDMARD plus anti-TNF
  2. Two or more cDMARDs: Modifications or additions of cDMARDs that have been treated prior to informed consent

Exclusion Criteria:

* Participants who may be pregnant or lactating women
* Participants who have contraindication to anti-TNF
* Participants who had participated in this study
An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients

Given the role of IL-17 in the development of entheseal-driven pathology, a therapeutic strategy aimed at blocking IL-17 would be a logical option for the treatment of enthesitis in psoriatic arthritis patients. This study will be the first randomized trial of a biologic therapy in participants with psoriatic arthritis, using imaging test.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older,;
* had received a diagnosis of psoriatic arthritis at least 6 months previously, fulfilled the Classification Criteria for Psoriatic Arthritis (CASPAR);
* had at least 1 active enthesitis (confirmed by ultrasound) ;
* had active arthritis (at least 3 tender/painful and 3 swollen joints) ;
* had active plaque psoriasis (there was no criteria for minimum psoriasis severity) at screening and baseline.

Exclusion Criteria:

* History of surgery or trauma at the site examined by ultrasound (hand, elbow, knee, ankle, etc.);
* Local injection of glucocorticoids or other drugs at the site examined by ultrasound in recent 6 weeks;
* Peripheral neuropathy;
* Use of IL-17 or IL-12/23 inhibitors in the last 12 months;Use of infliximab, adamumab, golimumab, and cetuzumab in the last 10 weeks;PUVA treatment for the last 4 weeks;Use of topical treatment or UVB phototherapy that may have an effect on psoriasis in the last 2 weeks;
* recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic disease; evidence of active or latent or inadequately treated Mycobacterium tuberculosis; aspartate transaminase (AST) or alanine transaminase (ALT) \>3x upper limit of normal (ULN) at screening; estimated creatinine clearance \<40 mL/min.
Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with kidney tumors.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of radiation in patients undergoing stereotactic radiotherapy for renal tumors.
* Determine radiotherapy-associated toxicity in these patients.

Secondary

* Determine preoperative pathologic response to this regimen in these patients.

OUTLINE: This is a dose-escalation study of radiotherapy.

* Radiotherapy: Patients undergo stereotactic radiotherapy to 1 tumor. Cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose (MTD) or upper limit is reached. The MTD is defined as the dose preceding that at which at least 2 of 4 or 3 of 8 patients experience dose-limiting toxicity (DLT). DLT is assessed at 4 and 8 weeks after radiotherapy.
* Surgery: Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.

After completion of study therapy, patients are followed periodically for at least 2 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Radiologically confirmed renal tumor

  * At least 4 cm in greatest dimension
* No clinically, radiologically, or pathologically involved lymph nodes
* No distant metastases

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Negative pregnancy test
* Fertile patients must use effective contraception
* Medically eligible for tumor resection
* No major medical condition or psychiatric illness that would preclude study compliance
* No active connective tissue disease, such as lupus or dermatomyositis
* No active Crohn's disease or active ulcerative colitis

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy
* No prior abdominal or pelvic radiotherapy
* No prior cryosurgery
* No prior radiofrequency ablation
Insoles Effect on Pain and Daily Activities

The aims of this study were to evaluate the effects of insoles on pain, daily activities and physical activity level, and to investigate the relation between satisfaction with the insoles and their actual use in individuals with LE pain.

Pain in weight-bearing joints limits individual's function and ability to perform daily activities, causes a negative effect on productivity and increased costs for social insurance. This pain is often the outcome of structural deformities or work-related foot pain often occurs in workers whose occupations include standing or walking for a long time.

One of the most common reasons for prescribing insoles is to enhance functioning by reducing nonspecific pain in the foot, leg or low back pain. Reduction of pain is expected to improve quality of life in daily activities such as work and recreational activities.

Persons actual use of the insoles, is a prerequisite for any effect it may have. It can be hypothesized that the use of the insoles is related to what the user thinks about their comfort, appearance, the amount of foot perspiration they induce, and other factors.

Eligibility Criteria:
Inclusion Criteria:

* Pain in lower extremities
* Aged 18 years or older
* Able to speak Swedish.

Exclusion Criteria:

* Pain due to a systemic or progressive disease
* Use of orthosis of other type than insoles
* Earlier foot surgery or current use of prosthesis.
Cognitive Processing Therapy for Syrian Patients With PTSD

Background: Studies among Syrian refugees showed high prevalence rates of PTSD. The objective of the present study was to investigate the effectiveness of Cognitive Processing Therapy (CPT) in treating patients with posttraumatic stress disorder (PTSD) using a clinical trial. Methods: Data will be obtained through interviewing patients seeking for PTSD treatment. Patients will be interviewed by a clinician and asked to complete the Clinician-Administered PTSD Scale (CAPS-5), Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI). Assessments will be conducted at baseline, 3-, and 12-months posttreatment. The primary outcomes will be the scores of CAPS, BDI-II, and BAI. Results: we predict that CPT will result in greater reductions in CAPS scores.

Although individuals with PTSD experience significant suffering, disability, and a challenging clinical course, there are still significant gaps in the evidence addressing effective treatment options. Therefore, in the current study CPT will determine the effectiveness in treating Syrian patients with PTSD. Current study significantly adds to the existing literature. It is a novel study in Egypt and adds to the literature.

Eligibility Criteria:
Inclusion Criteria Their nationalities are Syrians

* age older than 18 years and younger than 65,
* patients meeting current diagnostic criteria for PTSD as defined in DSM-5
* have a good knowledge of English-language (reading, writing, and comprehension) because all assessments and therapy materials were in English

Exclusion Criteria

* having mental retardation
* having schizophrenia (or any other psychotic disorders).
DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction

Prevalence of heart failure with preserved ejection fraction (HFpEF) continues to increase in the developed world, likely because of the increasing life expectancy and an increasing number of elderly patients.

Transthoracic echocardiography is essential for the diagnosis of HFpEF according to the current guidelines. The HFA-PEFF and H2FPEF diagnostic algorithms rely on clinical characteristics and echocardiography findings that indicate the presence of diastolic dysfunction.

These diagnostic algorithms are not applicable in remote areas where expert echocardiography cannot be performed due to the absence of modern ultrasound systems and lack of qualified specialists. Therefore, it is important to develop an algorithm to evaluate pre-test probability of HFpEF without echocardiographic markers, so it can be easily used in the primary outpatient care setting by any specialist.

The aim of this study is to find the associations between clinical and epidemiological characteristics and changes of intracardiac hemodynamics in patients with dyspnea and decreased exercise tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients complaining of shortness of breath, with two or more chronic non-communicable diseases (patients with comorbidities)

Exclusion Criteria:

* Morbid obesity;
* Any chronic diseases in the stage of exacerbation and / or decompensation;
* Systemic diseases, cancer;
* Cardiac arrhythmias: persistent atrial fibrillation or paroxysmal atrial fibrillation with frequent paroxysms;
* History of myocardial infarction, stroke, heart failure with reduced ejection fraction;
* Storage diseases, hypertrophic cardiomyopathy, concentric hypertrophy;
* Congenital and acquired heart defect;