cyrilzakka/clinical-trials huggingface dataset:
Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention

Rehabilitation after lumbar disc surgery (prolapse) focuses on various elements such as endurance, strength, stretching and information. Evidence concludes that it is not harmful to return to activity after lumbar disc surgery, and restrictions to activities after these operations are today more or less nonexistent. Some studies have shown that high intensity programs might be more effective, but they are probably more expensive. In recent years cognitive interventions have received more attention in rehabilitation programs after lumbar disc surgery. The cognitive approach is focused on providing patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases. A goal of the rehabilitation is to get the patient to resume normal activities. Reviews ask for how much treatment are needed in a rehabilitation program after lumbar disc surgery.

The study will be a randomized clinical trial. The study will compare two different post-operative rehabilitation programs (general information or general information + exercise therapy). Both groups will begin treatment 1 day after surgery. Subjects in exercise therapy group are supposed to continue with exercises 3 months.

In this study the following hypothesis will be studied:

1. Brief intervention, an educational model, alone after lumbar disc surgery do have the same effect on pain in legs and low back as brief intervention, an educational model, combined with exercise therapy.
2. Exercises which are instructed after lumbar disc surgery in a rehabilitation program, are being done by the patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with lumbar disc prolapse with radicular pain
* Age between 18 and 60

Exclusion Criteria:

* Previous lumbar disc surgery (prolapse)
* Spondyloarthritis
* Arthritis
* Systematic disease
* Heart disease
* Does not understand Norwegian language, spoken or in writing
Cardiovascular Effects of High-Intensity Interval Training (HIIT)

The purpose of this study is to determine the effect of high-intensity interval training (HIIT) in comparison to moderate-intensity continuous training (MCT) on blood pressure, blood vessel function, and blood pressure reactivity.

It is estimated that one-third of the adult population in the United States has blood pressure values that are classified as prehypertension. This slight elevation in blood pressure has been shown to result in an increased risk for developing hypertension and cardiovascular disease. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) recommends lifestyle modifications for individuals classified as prehypertensive. One lifestyle modification suggested by JNC7 is regular physical activity. Aerobic exercise, like moderate-intensity continuous training (MCT), has been shown to improve blood pressure, blood vessel function, and arterial stiffness in those with prehypertension. However, a major barrier to exercise adherence is the time commitment required. High-Intensity Interval Training (HIIT), which requires individuals to work at higher intensities for shorter durations, may offer an alternative training design that would reduce the time commitment. Previous studies have shown HIIT to be equal to or better at improving cardiorespiratory fitness and blood vessel function in multiple populations. Limited information is present on HIIT training in those with prehypertension. In this study, participants will be randomized into one of the two training program designs mentioned above (MCT or HIIT). Both programs will be completed over an 8-week period (3 sessions per week) and each training session will be supervised. Participants will complete testing visits before and after the training program to collect measures of cardiovascular health (exercise capacity, blood pressure, blood vessel function, and blood pressure reactivity). The goal is to compare the effects of the training programs on these measures of cardiovascular health.

Eligibility Criteria:
Inclusion Criteria:

* Blood Pressure less than 140/90 mmHg
* Sedentary

Exclusion Criteria:

* Known or major signs/symptoms of cardiovascular, pulmonary, renal, or metabolic disease
* Cancer
* Use of antihypertensive medication
* Current tobacco use
* BMI (body mass index) less than 30 kg/m2
* Postmenopausal
* Current pregnancy
* Current hormone replacement therapy
* Participating in regular aerobic exercise at least three times a week for 30 minutes at a moderate intensity for the past 3 months or more
* Not able to regularly exercise for any reason
Investigation of Multi-omics Technique to Predict the Efficacy of Chemoradiotherapy Combined With Immunotherapy for r/m NPC

The observational clinical study will recruit 50 recurrent and/or metastatic nasopharyngeal carcinoma (r/mNPC) patients, to investigate the prediction values of multi-omics technique for the efficacy of chemoradiotherapy combined with immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent or metastatic nasopharyngeal carcinoma patients
* All genders，range from 18～70 years old
* ECOG score 0 \~ 1
* Inform consent form

Exclusion Criteria:

* Have or are suffering from other malignant tumors;
* Participating in other clinical trials;
* Drug or alcohol addition;
* Do not have full capacity for civil acts;
* Mental disorder;
* Pregnancy or lactation;
* Severe complication, eg, uncontrolled hypertension.
Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement

The purpose of this research study is to use tools for measuring function and movement in pediatric populations to measure the impact of input orthotic interventions in children with cerebral palsy.

Sensory processing begets movement. In persons with disorders of posture and movement due to cerebral palsy, an impaired ability to integrate multiple senses including pressure from ground, limb proprioception, and vestibular inputs leads to a movement pattern that is coarse, spastic and inefficient. In the pediatric rehab clinic spastic movement disorders have been treated with flexible, molded orthotics for the foot and ankle (AFO) to enhance sensation of ground reaction forces, and flexible elastomeric compression garments to enhance body and limb proprioception. While the investigators observed substantial improvements in gait quality and postural stability using sensory input orthotics, these clinical observations have not been objectively quantified. The goal is to use validated tools for measuring function and movement in pediatric populations in order to gather data on the value of sensory input orthotic interventions in children with cerebral palsy.

Under the term, sensory input orthotic, the following items are included which will be used in this study. 1) A flexible, thin polypropylene shell ankle-foot orthotic designed according to Hylton et al. Journal of P\&O 1989. 2) Wearable elastomeric compression garments manufactured by SPIO or from the Boston Brace DMO garment line. 3) A vibrating anklet that provides subsensory vibrational stimulation to the leg, manufactured by Accelera.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cerebral palsy
* Ages 6 months to 21 years
* No prior prescription of sensory input ankle-foot orthotics
* Clinical diagnosis of abnormal gait and mobility

Exclusion Criteria:

• Joint contracture that severely limits function such as ability to passively open the hand, extend the arm at the elbow or to stand with feet flat on the ground or knees in an extended position.
Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee

The primary objective of this registry is to assess the functional outcome measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) for patients with medial unicompartmental osteoarthritis and osteonecrosis of the knee treated conservatively. The aim of the Focused Registry is to complete the data collection and enable a sound analysis for the Tomofix Small size study.

The aim of the Focused Registry is to complete the data collection and enable a sound analysis for the Tomofix Small size study.

The incidence of knee osteoarthritis (OA) is higher in Japan than in other populations. Respective prevalences of 47.0 and 70.2% in men and women for Kellgren-Lawrence Grades 2-4 knee OA are reported in Japanese patients aged 60 years and over.

First treatment options are pharmacological (i.e. NSAIDs) and non-pharmacological therapies (i.e. use of assistive devices, exercises, osteopathy, physical therapy), followed by injections of hyaluronic acid and other substances. If no such therapies are successful, surgical treatment options as unicompartmental knee replacement, total knee arthroplasty and high tibial osteotomy (HTO) are recognized. The discussion of which is the best therapy is still controversial. HTO may decrease the number of complications compared to total knee replacement or unicompartmental knee arthroplasty and leave the option for later replacement surgery.

In this project, patients are included who would be surgically treated with HTO with Tomofix small based on the investigator's assessment but refuse to have surgical treatment. They will be treated conservatively and are investigated to serve as reference to an ongoing clinical study investigating invasive treatment modalities.

Eligibility Criteria:
Inclusion Criteria:

* 40 years of age and older
* Patients with OA Grade 1-4 (Kellgren-Lawrence) or osteonecrosis (ON) Stage 2-4 (according to the Koshino classification)
* Indication for open wedge HTO with the TomoFix™ Small
* No ligamental laxity
* Able to understand and read country national language at an elementary level
* Ability to understand the content of the patient information / informed consent form
* Willingness and ability to participate in the registry according to the registry plan (RP)
* Signed and dated IRB/EC-approved written informed consent

Exclusion Criteria:

* Femoro-tibial angle (FTA) \> 190° (standing view x-ray)
* Flexion contracture \> 15°
* Total knee replacement or unicompartmental knee on the contralateral side
* Infections located between the middle of the femur and the ankle
* Systemic bacterial infections
* Severe osteoarthritis or surgery of the hip joint
* Smoking of more than 20 cigarettes per day
* Immunodeficiency or compromised host
* Patients who have participated in any other device or drug related clinical trial within the previous month
* ACL/PCL reconstruction of the same knee
* Severe osteoarthritis of the ipsilateral ankle joint
* HTO on the contralateral side
* Major surgery on both knees (minor surgery as arthroscopic meniscectomy and synovectomy is allowed)
Platelet-rich Plasma for Low Back Pain

This study aims to evaluate the effect of platelet-rich plasma (PRP) on discogenic low back pain by comparing the pre- and post-interventional outcomes in patients receiving intradiscal injection of autologous PRP.

Intervertebral disc (IVD) degeneration is an important clinical problem that often contributes to low back pain and degenerative disc diseases. Degeneration of the IVD induces anulus tears and fissures, which can cause severe discogenic low back pain. Because the IVD has little potential to self-regenerate, treatment of degenerative disc disease is one of the most challenging clinical problems facing the spine surgeon. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. The soluble releasate isolated from PRP has recently been demonstrated to influence the metabolism of intervertebral discs in vitro. Furthermore, an intradiscal injection of autologous PRP has been shown to induce restoration of structural changes in the rabbit annular injection model in vivo. This clinical trial aims to investigate the safety and efficacy of intradiscal PRP injection in patients with discogenic low back pain. The pre- and post-interventional imaging and clinical outcomes will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 60 years
* L-spine disc degeneration diagnosed by MRI
* Low back pain

Exclusion Criteria:

* Herniated disc
* With prior history of spine surgery
* With current or prior history of cancer
* With current or prior history of hematological disease
* Pregnancy
* Patients who will not cooperate with one-year followup
Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Patient has ocular hypertension or glaucoma in both eyes
* Requires IOP-lowering therapy in each eye

Exclusion Criteria:

* Active or recurrent eye disease that would interfere with interpretation of study data in either eye
* History of any eye surgery or laser in either eye within 6 months
* Required chronic use of other eye medications during the study
* Anticipated wearing of contact lenses during the study.
* Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software

The objective of this project was to investigate the short-term in situ anti-plaque effect of cymenol, using the Dentius Deep Plaque software


Eligibility Criteria:
Inclusion criteria were as follows:

* Systemically healthy volunteers
* Age between 20-45 years
* Presence of minimum of 24 permanent teeth
* No evidence of gingivitis or periodontitis (CPITN= 0)
* No presence of untreated caries at the start of the study.

Exclusion criteria were as follows:

* Smoker or ex-smoker
* Presence of dentures or orthodontic appliances
* Antibiotic treatment in the last 3 months or routine use of oral antiseptics
Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation

A quality colonoscopy examination remains as the gold standard for colorectal cancer screening, but effective large bowel cleansing prior to colonoscopy is still not achieved in all cases that undergo the procedure. Currently, the most widely used cleansing methods employ balanced electrolyte-polyethylene glycol (PEG) solutions. However, a very large volume of PEG solution is required for it to be effective, and many patients refuse to drink a sufficient amount due to non-palatability. In this study, the investigators compare a novel colon preparation method--bolus lukewarm saline with yoga exercise--with a PEG based solution (HalfLytely) for large bowel cleansing.

Effective large bowel cleansing prior to colonoscopy is still not achieved in all cases that undergo the procedure. The use of balanced electrolyte-polyethylene glycol (PEG) solution have improved the cleansing results and shortened the time needed for preparing the bowel. The problem with using PEG solution alone is the relatively large volume of the solution that the patients need to drink. The recommendation is to drink the solution until diarrhea fluid is clear and often 4 L or more is needed. Many patients refuse to drink the sufficient volume needed to get a clean colon due to non-palatability. Good results of bowel cleansing have also been reported with sodium phosphate solution or tablets.

The fluid volume needed to drink along with sodium phosphate is generally no problem but this regimen causes electrolyte disturbances and renal insufficiency that usually are subclinical and of no significance. Several combinations of PEG solution and laxatives have been tested before. Low-volume PEG plus Bisacodyl preparation was better tolerated but it was not as effective as standard large-volume PEG and associated with abdominal cramping.

PEG solution 2L and Bisacodyl is used for large bowel cleansing in many centers in the United States and is the standard regimen used in our colonoscopy unit. In this study the investigators compare this standard regimen taken day before colonoscopy with Bolus lukewarm saline solution taken orally with yoga exercise on the day of colonoscopy.

The result of large bowel cleansing is evaluated during the colonoscopy according to a validated scoring method. Time to the first bowel movement and total preparation time are compared. Solution palatability, patient acceptability, abdominal symptoms, discomfort and subjective grading of how hard/easy it was to complete the cleansing program are evaluated with questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled to undergo elective complete colonoscopy as an outpatient.
* Aged 18 or older.
* The patient gives written informed consent and can understand the information given.
* The patient can participate in the study only once.

Exclusion Criteria:

* Sodium chloride sensitivity.
* Limitation to exercise.
* Earlier resection of the large bowel or rectum.
* Known active colitis.
* Ileus or gastrointestinal obstruction.
Accessibility to New Drugs Versus SOC in Sweden

The healthcare system in Sweden is publicly funded and aims to provide equal access to care irrespective of socioeconomic status. This includes ensuring equity in drug treatment. Socioeconomic disparities have been shown to influence patient management and health outcomes in certain Swedish populations. The Swedish Board of Health and Welfare has stated that the prescription of new drugs, which are more expensive than generic standard of care drugs, might be influenced by patients' socioeconomic status.

To evaluate the association between socioeconomic factors and use of a DOAC (rivaroxaban, dabigatran, or apixaban) or standard of care (warfarin) in patients with NVAF in Sweden.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years in Sweden with a diagnosis of NVAF (identified using International Classification of Diseases, version 10 \[ICD-10\]) codes in the National Patient Register) between 1 December 2011 and 31 December 2014 and with a first dispensed prescription for either a DOAC or warfarin following their NVAF diagnosis.

Exclusion Criteria:

* Patients with a dispensed prescription for a DOAC or warfarin prior to the index date (the date of first DOAC/warfarin purchase designated the index date)
* Patients with a dispensed prescription for more than one anticoagulant at index date.
* Patients with valvular atrial fibrillation
Plasma Injections Plus Exercise for Patellar Tendinopathy

This is a randomized controlled clinical trial to investigate the effectiveness, safety and tolerability of platelet-rich plasma (PRP) injections for treatment of patellar tendinopathy in adults 18-50 years of age. Subjects will be randomly assigned to three parallel treatment groups:

1. Leukocyte-rich PRP injection + exercise
2. Leukocyte-poor PRP injection + exercise
3. Saline injection + exercise (control) Primary endpoints are (1) the number (rate) and severity of adverse events as reported by both patients and study physicians during the first 12 weeks after initiation of treatment, (2) patient-rated tolerability of treatment; (3) the change in function (VISA score) and treatment success (global improvement scale) over six months of a post-injection exercise protocol.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 and ≤ 50 years of age at Enrollment Visit
* Documentation of a clinical diagnosis of patellar tendinopathy, grade-IIIB Blazina stage, confirmed on ultrasound
* Previously tried an exercise program of at least six weeks duration
* Fluent in official language of study site
* Written informed consent obtained from subject
* Normal values on screening laboratory panels (CBC, PT, PTT, INR, serum creatine, ALT, ALP, AST, bilirubin, albumin)

Exclusion Criteria:

* For women of child-bearing potential, positive pregnancy test at enrollment visit
* Major surgery in the past three months
* Surgery on the symptomatic knee
* Bleeding disorder
* Systemic inflammatory disease
* Arthritis or degenerative knee condition
* Recent fluoroquinolone use
* Subjects who have any requirement for the use of systemic steroids or immunosuppressants
* Subjects who are known to be HIV positive
* Uncooperative patient, or patients who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Biofeedback and Cortical Excitability

Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions.

Introduction: Nervous control of pelvic floor is not much known. The dysfunction of this musculature, and particularly of the external anal sphincter, is a frequent cause of anal incontinence and/or dyschesia. Biofeedback training is often offered to patients suffering from incontinence or constipation. However, its mechanisms of action is still controversial.

Objective of the study: to compare excitability of the cortical area responsible for control volunteer of the external anal sphincter in healthy subjects before and after 4 biofeedback sessions.

Subjects and methodology: we offer to perform two groups of 12 healthy subjects (one active and one control group) without any neurological or digestive disease and having never performed biofeedback. In each group, cortical excitability will be evaluated by cortical magnetic stimulation (curve intensity/amplitude, silent period, inter-stimulus period, motor threshold) before and after 4 biofeedback sessions (one session by week) in active group or 4 placebo sessions (placebo group).

We hope to show a modification of cortical excitability in subjects performing biofeedback compared to others.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 18 years old and 35 years old
* Right handed\*

Exclusion Criteria:

* Pregnancy
* Pace-maker or other metallic piece implanted in the body
* Neurological disease
* Epilepsy
* Digestive disease
* Traumatic delivery
* Anorectal surgery
* Biofeedback
* Psychiatric disease
* Treatment anti-epileptic, hypnotic, psychotropic
* Participation to a previous protocol within 1 month
Improving Community Based Tuberculosis Care in Ethiopia

The purpose of this study is to see if involving community health workers improves tuberculosis case finding and treatment outcome.

Tuberculosis suspects in the study area

Outcome smear positive tuberculosis cases identified smear positive tuberculosis cases treated

Eligibility Criteria:
Inclusion Criteria:

* suspects of pulmonary tuberculosis

Exclusion Criteria:

* not in the study area