cyrilzakka/clinical-trials huggingface dataset:
Effect of Spinal Ketorolac on Mechanical Hypersensitivity After a Total Hip Replacement

Chronic pain in patients following total hip replacement seems to be a significant problem. Previous research has shown that more effective pain management in the early postoperative period may decrease the incidence of the development of chronic pain states.

This study will evaluate whether ketorolac (a non steroidal anti-inflammatory drug) given into the spinal fluid before surgery will reduce the area of sensitivity (or pain to light touch) following surgery. Patients will be monitored during their postoperative hospital stay and then contacted by telephone at 8 weeks and 6 months after surgery and questioned about any pain they are having at their surgical site. Patients that are still experiencing pain at 6 months will be asked to return to the medical center for the study staff to assess their pain or sensitivity at the surgical site.

Surgery results in hypersensitivity to mechanical stimuli surrounding the wound and in a subset of patients, also results in chronic pain. The purpose of the study is to test whether intrathecal ketorolac, by selectively and effectively blocking cyclooxygenase in the spinal cord, will reduce hypersensitivity surrounding the surgical wound in patients with high risk for developing chronic pain after surgery. We have chosen to study patients having total hip arthroplasty (THA) because chronic pain seems to be a significant problem after surgery. We will sample cerebrospinal fluid (CSF) prior to injection of the study medication for subsequent prostaglandin E2 (PGE2) analysis in each patient. We will also assess each patient at 48 hours after their surgery for hypersensitivity at their surgical site.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I, II, III
* \> Age 18
* Primary unilateral total hip arthroplasty under spinal anesthesia

Exclusion Criteria:

* Known allergy to study medication
* Weight \> 300 pounds
* Obstructive sleep apnea
* Patients with severe renal (kidney) or hepatic (liver) disease, allergy to ketorolac, amino amide local anesthetic, or contraindications to spinal anesthesia
* Patients on dialysis for kidney failure or patients that are jaundice or have a diagnosis of liver failure
* Patients routinely taking narcotic pain medications for pain other than their primary hip pain
* Patients that are taking Lyrica (pregabalin) or Gabapentin (neurontin) for the treatment of seizures
Prevalence of Alpha-1 Antitrypsin Deficiency in Chronic Obstructive Pulmonary Disease (COPD)

Alpha-1 antitrypsin deficiency (AATD) is considered a rare genetic cause of chronic obstructive pulmonary disease (COPD) and liver disease. Recent data has suggested that AATD is not as rare as originally thought and undetected AATD may account for COPD in some patients. This study was designed to evaluate the frequency of undetected AATD in a population reporting to academic pulmonary function testing facilities who meet criteria for the diagnosis of COPD. All individuals meeting GOLD criteria for COPD will be consented and offered free testing for AATD. The results will help identify the percent of those with COPD who have undetected AATD.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults at least 18 years of age able to understand and consent to the procedures of this protocol.
* All races and ethnicities will be considered for this study.
* Post-bronchodilator values for pulmonary function tests on the day of enrollment with an FEV1 \< 80% of predicted and FEV1/FVC \< 70% (at least GOLD stage II).
* Subjects who have been tested for Alpha-1 in the past but do not know their genotype or phenotype may be included in this study.

Note: For the inclusion criteria the investigators will use the patient's GOLD status, based on percent predicted (FEV1 \< 80% of predicted); however, after sending the absolute value of FEV1 to the Data Coordinating Center (DCC) the DCC will calculate the percent predicted using a standardized formula (NHANES III). For sites that do not use this predicted formula, the results obtained at the DCC may differ from those used for subject enrollment. (For example, a subject found to have an FEV1 of \<80% at the study site could have an FEV1 \> 80% when the DCC recalculates it). Enrollment will be based on the percent predicted at each study site. If necessary, the data from this small number of outliers will be analyzed separately.

Exclusion Criteria:

* Subjects in whom post-bronchodilator spirometry is not performed.
* Subjects whose ordering physician has specifically requested that his patients not be considered for enrollment.
* Patients who have been tested for Alpha-1 in the past and know their genotype or phenotype.
Primary Immunodeficiency in Kuwait

* Background/Rationale: Epidemiological data about Primary Immunodeficiency Disorders (PIDD) in Kuwait is needed to better understand peculiarities and to compare them with other regions and ethnicity.
* Study hypothesis: PIDD is relatively common in Kuwait compared to populations from different geographic areas. The distribution of PIDD in Kuwait is different from other geographic areas with more severe forms being more frequent.
* Brief inclusion and exclusion criteria of study participants: PIDD patients presented at different clinics/hospital in Kuwait. Patients with secondary immunodeficiencies (drug induced, virus induced, and immunodeficiency associated with metabolic disorders... ect), will be excluded
* Estimated sample size of the study: All patients who were registered in KNPIDR since 2004 will be included in the study along with the new patients who will be recruited during the study period.
* Primary objectives:

  * Determine the prevalence and frequency of different PIDD in Kuwait
  * Identify clinical presentation patterns for PIDD in Kuwait
  * Identify natural history of PIDD in Kuwait
  * Help to asses epidemiology of PIDD in Kuwait
  * Determine particularities about PIDD affecting the population in Kuwait
  * Determine the health impact of PIDD in Kuwait
  * Development of strategies to improve the care and the quality of life of patients with PIDD


Eligibility Criteria:
Inclusion Criteria:

* PIDD patients presented at different clinics/hospital in Kuwait
* Exclusion Criteria: Patients with secondary immunodeficiencies (drug induced, virus induced, and immunodeficiency associated with metabolic disorders... ect)
Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play

The approach described here is based both on theoretical concepts and on the work of several teams of researchers. By positioning the baby and the appropriate adult, a speech bath, a sustained look and an expressive face, it is hypothesized that this early communication exercise will significantly improve the transition from passive feeding, active feeding of the premature child, from a qualitative and quantitative point of view.


Eligibility Criteria:
Inclusion Criteria:

* Age of child at birth: \<32 WA justified by the greater prevalence of oral disorders in these children.
* Age of the child at the start of the study: 35 WA, ie at the beginning of the establishment of active feeding within the unit.

Exclusion Criteria:

* Children with oral malformations
* Contra-indication to the realization to the ALIJEU (infection in progress, hemodynamic instability, etc.)
* Medical contraindications to oral diet
Functional Outcome After Minimally Invasive Pyeloplasty for Adult Patients With UPJO

an intervention study on adult patients with uretero-pelvic junction obstruction (UPJO) due to crossing vessels would be managed either through classic dismembered pyeloplasty or vascular hitch.

in recent studies, some patients with crossing vessels UPJO could be managed by vascular displacement of these vessels, what is named as vascular hitch or vasculopexy in a way to avoid classic dismembered technique. this newer technique is supposed to provide comparable results to the classic technique but with lesser operative time and shorter hospital stay. in the era of minimally invasive procedures, robotic assisted or laparoscopic vascular hitch could provide many advantages over the classic open technique.

Eligibility Criteria:
Inclusion Criteria:

* all patients with UPJO above 18 years
* UPJO caused by crossing vessels confirmed by CT angiography
* Symptomatic UPJO

Exclusion Criteria:

* recurrent UPJO after a previous trial of open repair ,
* secondary UPJO after open renal surgery.
* UPJO in non functioning kidney
Susceptibility Testing Guided Versus Empirical Therapy for Refractory H. Pylori Infection

Aim: Therefore, we aimed to

1. compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in the third-line eradication for refractory H. pylori infection
2. assess the long-term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors.

Methods: This will be a multi-center, open labeled trial

Patients: 360 patients with failure to H. pylori eradication for at least two times will be enrolled Determination of antibiotic resistance of H. pylori:

Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics.

Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Susceptibility testing guided therapy or (B) Empirical therapy

Outcome Measurement:

Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses.

Secondary End Point: 1. Eradication rate according to per protocol analysis (PP analysis); 2. Frequency of adverse effects.


Eligibility Criteria:
Inclusion criteria

* Adult (equal or greater than 20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled.
Abatacept s.c. for aGVHD Prevention in Haplo-HCT

Acute graft-versus-host disease (aGVHD) is a potentially fatal complication after allogeneic hematopoietic cell transplantation (HCT), particularly for that with a HLA-mismatched donor. Abatacept has been demonstrated as a potent drug to reduce the risk of aGVHD, but the efficacy of subcutaneous form has yet been investigated. This trial is designed to preliminarily determin the efficacy and saftey of subcutaneous abatacept in the prevention of aGVHD after haplo-identical HCT.


Eligibility Criteria:
Inclusion Criteria:

1. Age≧18 years
2. ECOG score 0-2 / Karnofsky score≧80
3. haplo-HCT is proposed
4. Conditioning with motified Bu/Cy+ATG regimen
5. Having the following hematologic malignancies with transplant indications:

   1. Acute leukemia
   2. Myelodysplastic syndrome
   3. Aggressive lymphoma
6. Expected survival ≥ 3 months
7. Written informed Consent can be acquired
8. Agree to use effective contraception

Exclusion Criteria:

1. With a history of allo-HCT previously
2. Allergic/intolerant to Abatacept
3. Contraindications to the use of Abatacept
4. HIV infection, or active HBV infection or HCV infection
5. Uncontrolled active infection
6. Vital organ function intolerated to transplantation
7. Other malignancies except for the following diseases: malignant tumors that have been cured for at least 3 years without active lesions; adequete treated non-melanoma skin cancer, malignant amygdala, and carcinoma in situ without active lesions
8. Evidence of complications or medical conditions that may interfere with research or put the subjects at serious risk, including but not limited to severe cardiovascular disease (e.g. New York Heart Association grade III or IV heart disease, myocardial infarction in the past 6 months, unstable arrhythmia or unstable angina) and/or severe lung disease (e.g. history of severe obstructive lung disease and symptomatic bronchospasm)
9. Pregnant and lactational women
10. Any life-threatening disease, medical condition, or organ dysfunction unfit for participants, or may interfere with the absorption or metabolism of Abatacept
Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients

The purpose of this study is to evaluate the clinical results of implant-retained mandibular overdentures in edentulous patients.

The survival of implants,condition of the peri-implant soft tissue were evaluated. And patients' perceptions regarding the outcome were assessed on visual analog scales (VAS), oral health impact profile-14 (OHIP) and semantic differential scale questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. Patients treated with implant retained overdentures
2. With the ability to read and sign the informed consent document

Exclusion Criteria:

1. Jaw radiotherapy treatment before and after implanting
2. Patients who suffered with mental and psychological disease will influence their oral health normal maintenance
3. Can not read and sign the informed consent document
Organ Motion and Early Tumor Response Measurement

To quantify motion based variation of the target volume of the primary tumor over the course of chemoradiotherapy in esophageal cancer patients, and to use this information to calculate appropriate PTV (planning target volume) margins according to the margins recipe for patients receiving trimodality (neoadjuvant chemoradiation and surgery) or definitive chemoradiation in order to personalize radiation treatment, resulting in either better target coverage or a reduction in normal tissue radiation exposure.

A single center prospective observational study will be performed in esophageal cancer patients. This study registers motion of the esophageal tumor, using 4D planning CT scans and repeated 4D CBCT scanning. Motion of fiducial markers inserted into the esophageal wall, will be used as a surrogate for tumor motion in the limited image quality of CBCT scans.

Patients planned for trimodality treatment will additionally be imaged by serial 4D Pet CT and MRI in week 0 (before start chemoradiotherapy), week 3 (during chemoradiotherapy) and week 10 (just prior to surgery) to observe (early) signs of tumor response.

Patients planned for definitive chemoradiation will not receive extra MRI imaging during treatment because of the inability to correlate this imaging with pathological response.

Eligibility Criteria:
Inclusion Criteria:

1. Histologic evidence of invasive adenocarcinoma or squamous cell cancer of the esophagus
2. Patient eligible for trimodality treatment (chemoradiotherapy and surgery) or definitive chemoradiotherapy
3. T3N0M0 or T1-4N1-3M0. Patients with M1 disease solely on the basis of supraclavicular metastasis and not a junction tumor as primary are eligible. (AJCC 7th edition,).
4. WHO performance status ≤2 (WHO scale)
5. Clinically operable for R0 resection in the opinion of an experienced upper gastrointestinal or thoracic surgeon for patients planned for trimodality
6. Tumor localization at least 2cm from the upper esophageal sphincter and invading no more than 5cm into gastric cardia
7. Age ≥ 18 years
8. Written informed consent before endoscopy or EUS

Exclusion criteria:

1. Prior treatment with thoracic surgery or thoracic radiotherapy
2. Pregnancy
3. Severe cardiopulmonary restriction
Validation of FDG-PET Segmentation Tools for Tumor Delineation by Correlation of CT- and FDG-PET Volume Measurements With Histopathology of Nodal Metastases of Head and Neck Carcinomas.

Various methods of FDG-PET signal segmentation will be validated by correlation of histopathologically measured tumor dimensions in lymph node dissection specimens of head-and-neck cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients with N+ squamous cell carcinoma of the head and neck, planned for neck dissection.
* Age \>18 years.

Exclusion Criteria:

* Pregnancy.
* Women breast feeding
Effect of Pharmacological Anti-lipolysis on FFA and VLDL-TG Metabolism Before and During Exercise

This study will investigate free fatty acid and VLDL-TG metabolism before and during exercise with and without pharmacological antilipolysis by the niacin antagonist Acipimox. Main focuses will be VLDL-TG and free fatty acid metabolism as well as expression of membrane proteins in fat- and muscle biopsies.

Insulin resistance in liver and skeletal muscle is of central pathogenic significance in the development of type 2 diabetes. The molecular connections are unresolved but high levels of free fatty acids and triglyceride is probably involved. Diabetic subjects and to a lesser extent obese subjects have increased triglyceride levels, this could be due to an abnormal turnover of VLDL-TG. It is not yet investigated whether VLDL-TG kinetics changes during pharmacological antilipolysis. Using the aseptic ex-vivo labeling technique (developed in our laboratories) we will investigate this issue in sedentary healthy men. After a 3 hour basal period subjects will exercise on a bike for 60 minutes at 60% of VO2max. In both basal and exercise period one muscle and one fat biopsy will be obtained, further blood samples will be drawn to examine FFA and VLDL-TG metabolism etc..

This new knowledge will contribute to the understanding of metabolic disorders like type 2 diabetes and obesity.

Eligibility Criteria:
Inclusion Criteria:

- healthy, untrained males

Exclusion Criteria:

* medication
* history of malignancy, alcohol abuse or drug abuse
* participation in isotope trials in the last 6 months
Efficacy and Safety of the Device Siesta-SystemTM for Inducing Objective Sleep and re Rest

NTRODUCTION: The investigators have developed a new device to help passengers of vehicles to rest, sleep, and to avoid cervical injuries due to sleepiness postures while travelling. The device is attached to the headrest and is based in a new concept called "dynamic vertical holding of the head and neck". It could also provide some help in avoiding accidents by allowing a sleeping time for a secondary driver while the main one is driving. Several studies have shown that up to 30% of car crashes are related to sleepiness.

AIM: To estimate the efficacy and safety of a new device in "patent pending" phase to facilitate the sleep and rest in the passenger.

METODOLOGY: DESIGN: Prospective, cross-over and open clinical assay, comparing the results of 40 different passengers during a journey after using both systems, that is the new device and the standard headrest.

MEASUREMENTS: A) Standard polysomnography for 3 and a half hours during the night; B) Anthropometric and clinical variables; C) Sleepiness scale and Epworth sleepiness; D) Questionnaires of sleep, health and quality of life. E) Evaluation of the neck posture in recorded images.

ANALYSIS: To compare the results of questionnaires of sleep quality, comfort and safety as well as the images recorded and polysomnographic variables of objective sleep variables obtained by the device Siesta-SystemTM and the conventional headrest.


Eligibility Criteria:
Inclusion Criteria:

* Adults between 30 and 80 years

Exclusion Criteria:

* People with back pain or hip area on trips of 5 hours. Acute passenger. Serious chronic illness. Depressions. Medicated people with sleep inducing drugs or stimulants. People with insomnia relevant and apnea-hypopnea syndrome during sleep (SAHS) will be excluded by validated sleep test. People who have drunk in the last 6 hours coffee, other drinks, exciting, or an amount of alcohol over a glass of wine and those who stayed more than 30 minutes las12 hours before the test. People who declare themselves unable to relax in a vehicle while riding as co-pilots. Morbid obesity (BMI\> 40 kg/m2) and any musculoskeletal disorder defined as a disease that can trouble the rest and sleep onset in a car. Latex allergy.
Binge Eating Disorder Treatment Study

The main objective of the proposed study is to determine whether the effectiveness of a group therapy treatment for Binge Eating Disorder (BED) is improved and attrition reduced by optimally matching women with BED who have high attachment anxiety to Group Psychodynamic Interpersonal Psychotherapy (GPIP). This study represents the next phase in a program of research stemming from a previously conducted randomized controlled trial (RCT).


Eligibility Criteria:
Inclusion Criteria:

•Overweight Women 18 years of age or older who binge eat at least twice per week for the past month.

Exclusion Criteria:

* unable speak English
* history of an eating disorder other than Binge Eating Disorder
* concurrent Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of bipolar disorder, psychosis, drug or alcohol problem
* pregnant or planning on becoming pregnant within the next year
* are currently or plan to become enrolled in a weight loss program within the next year
Investigation of the Effectiveness of Craniosacral Therapy in Patients With Multiple Sclerosis.

Although the cause of Multiple Sclerosis (MS), one of the common demyelinating diseases of the central nervous system, has not yet been fully elucidated, autonomic nervous system dysfunction has been suggested in its etiology. Symptoms such as fatigue, problems with bladder, bowel, cardiovascular, sleep, sexual and sweating functions, abnormal sympathetic skin response or decreased heart rate variation support this hypothesis.

In the treatment of many neurological diseases such as Multiple Sclerosis, complementary medicine practices and non-traditional therapies have recently been shown to be effective in addition to conventional practices. One of these practices, craniosacral therapy (CST), uses manual palpation and manipulation of the craniosacral system to influence sensory, motor, cognitive and emotional processes in the nervous system. In addition, it is thought that applying external force to certain bone elements can have a positive effect on various symptoms in patients with MS, based on the knowledge that it can be transmitted within the system.

In addition to pharmacological treatments, many non-pharmacological treatment modalities such as physiotherapy applications, sleep hygiene training, relaxation techniques, behavioral therapy and cognitive therapies are used in the treatment of MS symptoms. Recently, complementary medicine practices and non-traditional therapies have been shown to be effective in the treatment of many neurological diseases, including MS. Among these methods, craniosacral therapy (CST) has been shown to be effective in the treatment of various neurological conditions affecting the central nervous system. CST is defined as an alternative, massage-like treatment approach using gentle manual force to address somatic dysfunctions of the head and the rest of the body. The interplay of diagnosis and treatment aims to mobilize cranial sutures that abnormally restrict physiological movement.

CST is an approach widely used in adults and children, in different clinical settings and conditions. Based on the knowledge that the application of external force to certain bony elements of this system can be transmitted within the system, it can be considered that craniosacral therapy may have a positive effect on various symptoms in patients with MS. In the light of the results obtained as a result of the study, CST may provide ideas to clinicians and researchers as an alternative and complementary method in the treatment of MS.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* Definitive diagnosis of MS by a neurologist
* EDSS score between 1-5.5
* Not receiving active physical therapy services
* Volunteering.

Exclusion Criteria:

* Having a neurological disease other than MS
* Attacks in the last three months
* Corticosteraoid use
* History of surgery on the spine
* Central and peripheral nervous system disease
* Pregnancy
* Oncological diseases
* Severe comorbid somatic and psychiatric disorders
* Receiving invasive/manipulative treatment.