cyrilzakka/clinical-trials huggingface dataset:
Observational Study On Compliance Of Statin Treatment Of Patients With High Blood Cholesterol Levels

The purpose of the study is to show the compliance rates of the patients to statin treatment and the reasons of non-compliance.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with dyslipidemia and taking or planning to take statin treatment.
* Patients living in the same city of the study center. o Patients aged 18 years and over.

Exclusion Criteria:

* Patients with severe systemic disease
* Patients with alcohol and drug addiction and/or mental disease
* Patients nursing or pregnant, or planning to get pregnant during the study
Individualised Gait Modification Strategies in Alkaptonuria Patients

This study evaluates the efficacy of a gait modification intervention using real-time biofeedback on reducing the knee joint loading in Alkaptonuria patients during treadmill walking. It will also assess whether the individualised adopted gait modification can be retained without feedback and during over ground walking.

Alkaptonuria (AKU) is a degenerative disease affecting the cartilage of the joints. The disease affects movement function, particularly walking/gait which is an important activity of daily living. It is believed that increased joint loading measured by the moments acting upon the joints, contributes to the degeneration of joint cartilage in Alkaptonuria, particularly in the weight bearing joints such as the knee and hips, resulting in accelerated progression of painful symptoms. Currently there is no cure for Alkaptonuria and the current management includes joint replacement surgery. Gait modification strategy interventions could be a non-invasive alternative which could delay the time to surgical interventions by reducing or altering joint loading and stalling the progression of disease.

The aims of this study are 1) to determine if individualised gait modification strategies can be used to reduce the 3D knee joint loading, 2) to determine if the gait modifications can be retained without feedback during over ground walking and 3) to determine the individualised gait modification strategies adopted by AKU patients.

Gait data will be measured and quantified using the non-invasive typical clinical gait analysis set up, using 3D motion capture combined with force data whereby joint angles, moments and powers can be calculated in all 3 planes of motion during treadmill walking. The intervention will involve real-time biofeedback using Motek's M-Gait treadmill. Due to the heterogeneity of the sample, each AKU patient will act as their own control. Gait data will be compared pre- and post-intervention and a validated pain score will be used to identify any patterns with knee pain and adopted gait modifications.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of Alkaptonuria
* Able to understand written and spoken English.
* Willing and able to give informed consent to participate
* Above the age of 18.

Exclusion Criteria:

* The reliance on or use of a walking aid.
* Any previous lower limb joint replacements.
* Any severe pain or unable to walk comfortably and consecutively for 20 minutes.
* Pregnant
Dose-Escalation Study of HTX-034 Following Bunionectomy

This is a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b will evaluate escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 will be a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b compared with bupivacaine HCl.


Eligibility Criteria:
Inclusion Criteria:

* Is medically fit to undergo an elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia; no neuraxial technique (eg, no spinal, epidural, or general anesthesia).
* Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study; sterile, or using acceptable contraceptives.

Exclusion Criteria:

* Had contralateral foot bunionectomy in the past 3 months.
* Has a planned concurrent surgical procedure.
* Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
* Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
* Has received or is taking a contraindicated or prohibited medications.
* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
* Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
* Has a history of clinically significant cardiac abnormality such as myocardial infarction within 6 months.
* Has a history of coronary artery bypass graft surgery within 12 months.
* Has a history of known or suspected coagulopathy.
* As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
* Has uncontrolled anxiety, psychiatric, or neurological disorder.
* Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
* Has undergone 3 or more surgeries within 12 months.
* Has a known history of glucose-6-phosphate dehydrogenase deficiency.
* Has any of the following laboratory abnormalities during Screening (1 retest permitted):

  * Severe liver function impairment.
  * Severe kidney function impairment.
  * Platelet count \<100,000/μL, hemoglobin \<12 g/dL, or hematocrit \<35%.
* Has a body mass index (BMI) \>39 kg/m2.
Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

The efficacy of fentanyl TTS for the treatment of neuropathic pain remains to be established, although opioids in general are clearly effective for neuropathic pain and fentanyl TTS has been shown to be effective for treating other types of pain. We propose to measure functional outcomes, pain relief and side effects of fentanyl TTS for the treatment of neuropathic pain. Measures will be made at baseline and after titrating the drug to an effective level.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Neuropathic pain persisting for \> 3 months
* Pain over the immediate previous three months
* The average of the least and usual pain intensity rating of 3 or greater (0-10 numerical rating scale) during the last week prior to enrollment

Exclusion Criteria:

* A history of substance abuse
* Allergic reaction to an opioid
* Significant pain of alternate etiology other than the neuropathic pain state
* Severe pulmonary disease
* Recent myocardial infarction (within the preceding three months)
* Pregnancy
* Dementia
* Encephalopathy
* Those with life expectancy of less than six months and HIV seropositivity.
Selective COX-II Inhibitor as a Palliative Therapy in Patients With R1 or R2 Resection for Disseminated Stomach Cancer - A Multi-Centre Prospective Randomized Controlled Trial

The purpose of this study is to investigate the effect of selective COX-II inhibitor in patients with regionally disseminated stomach cancer treated by palliative resection (so called R1 or R2 gastrectomy).

Cyclo-oxygenase (COX) is a family of enzymes regulating the conversion of arachidonic acid to prostaglandins. COX-II is an inducible enzyme, which expresses excessively when there are stimuli such as inflammation or hypergastrinaemia. Up to 40% of patients with stomach cancer are found to have disseminated disease during surgical exploration. While palliative resection could offer a marginal benefit in the survival of these patients, almost all patients will die of progression of disease within a short time span. Palliative chemotherapy has been used in the past. However, there is no evidence that the chemotherapy can confer any survival advantages, and the side-effects and toxicity of the treatment may indeed compromise the quality of life of these patients. With a better understanding of the relation between COX-II and stomach cancer, it may be possible to suppress the progression of the residual cancer cells after the palliative resection by giving the patients selective COX-II inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* Stomach cancer with peritoneal or lymphatic spread beyond the scope of curative resection
* Palliative resection can be performed
* Normal RFT

Exclusion Criteria:

* Solid organ metastases
* Poor performance status
* On long-term aspirin or NSAID
* Renal or hepatic dysfunction
* Bleeding disorder
* Hypersensitive to COX-II inhibitors/aspirin/NSAID
* No history of myocardial infarct or stroke
Effect of the Electronic Cigarette on Withdrawal Symptoms

Study rationale: Sensory/behavioural elements of smoking play a role in smoking behaviour and may have a potential to assist smoking cessation. Among current treatments for smokers, only the nicotine inhalator is attempting to address such factors. The inhalator's efficacy does not exceed that of the other nicotine replacement therapy (NRT) products, but it mimics the relevant sensory input to only a limited extent, and its nicotine delivery is dependent on intensive puffing. Recently a new product, the Electronic Cigarette (E-C) has become available, which provides a more realistic behaviour and sensory replacement for smoking and can provide good nicotine levels with less effort.

Primary objective: To compare E-C and nicotine inhalator in their effects on tobacco withdrawal symptoms over 24hr abstinence.

Hypotheses: E-C will be more effective than the inhalator in reducing withdrawal symptoms and craving and elicit more favorable user ratings. It will also provide higher nicotine levels.

Study design: In a cross-over study, participants will be randomized to the sequence of conditions and provide baseline measures and samples for salivary cotinine analysis. They will be asked to abstain from smoking their usual cigarettes and use the allocated product over 24 hours. They will return to the study centre the following day, and complete measures of craving and withdrawal, ratings of subjective and sensory effects of the products, product satisfaction, and adverse effects. They will also provide saliva samples for cotinine analysis. Abstinence from smoking will be verified with CO readings.

There is considerable interest in E-Cs at the moment and the study would provide information on whether the E-C surpasses the tried and tested nicotine inhalator. If so, it would open a possibility of its utilization in smoking cessation, and provide encouragement for further examination of the role of sensorimotor replacements in the treatment of tobacco dependence.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers smoking at least 12 cigarettes per day
* First cigarette smoked within 60 minutes of waking up
* Willing to abstain from smoking for one day in 2 consecutive weeks.

Exclusion Criteria:

* Under 18 years of age
* Current psychiatric illness
* Pregnant or breastfeeding
* Enrollment in other research projects
* Used electronic cigarette and/or nicotine inhalator before
Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF)

This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in a TLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 15,000 cases worldwide.

This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive TLIF surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus during their TLIF operation. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and BMP.

Eligibility Criteria:
Inclusion Criteria:

1. Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier
2. Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to S1)
3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
4. 18-70 years of age at the date of written informed consent
5. Able to undergo surgery based on physical exam, medical history and surgeon judgment
6. Expected to survive at least 2 years beyond surgery
7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
8. Signed and dated Informed Consent Form

Exclusion Criteria:

1. Patient has a mental or physical condition that would limit the ability to comply with study requirements
2. Lumbar spine abnormality requiring treatment at more than two levels
3. Systemic or local infection; active or latent
4. Previous failed fusion at the operative level
5. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
6. Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
7. Pregnant, or plans to become pregnant during the study
8. Subject is a prisoner
9. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
10. A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents
11. Participating in another clinical study that would confound study data
CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies

The CamPROBE study investigates the rate of infective complications using the Cambridge Prostate Biopsy Device method of local anaesthetic transperineal prostate biopsies.

The current method for diagnosing prostate cancer requires a biopsy needle to pass through the bowel wall to reach the prostate. Bacteria in the bowel inevitably enter the urinary system and blood stream. A significant number of men develop infections despite preventative antibiotics (1 in 10 develop fevers/shivers and 1-2 in 100 get a life-threatening infection). It is crucial we find a safer biopsy method for suspected prostate cancer as over 1 million rectal biopsies occur each year.

A safer alternative device was developed, performed under local anaesthetic using the transperineal route: CamPROBE (Cambridge Prostate Biopsy Device). CamPROBE biopsies are taken through the perineum (the area under the testicles), so there is no infection risk, and it's just as good at diagnosing prostate cancer. This investigation progresses from a prototype to a disposable, single use device that any UK hospital can use. The study will assess CamPROBE's ability to reduce infections from prostate biopsies and its usability as an alternative to the current standard biopsies.

Men recommended to undergo a prostate biopsy will be eligible for this multi-centre study. For each patient, the study will take approximately 30 days, consisting of: recruitment, 1 day for the procedure (replaces the standard biopsy pathway) and questionnaires on day 1, 7 and 30. This timeframe will not introduce delays in the patients' normal standard care pathway. Patients will have a transperineal biopsy with CamPROBE instead of the current transrectal method. Biopsy samples will be treated the same as standard procedure. Patients' acceptability of the procedure and complications will be measured using patient self-reported questionnaires.

Eligibility Criteria:
Inclusion Criteria:

To be included in the clinical investigation the participant must:

* Have given written informed consent to participate
* Be aged 18 years and over
* Be suitable for a prostate biopsy and clinically due to have a biopsy for diagnostic or surveillance purposes
* Be willing and able to comply with scheduled visits and completion of study questionnaires

Exclusion Criteria:

The presence of any of the following will preclude participant inclusion:

* Contraindication to a prostate biopsy
* Previous perineal or anal surgery
* Unable to lie down with legs in a stirrup for at least 45 minutes, as assessed by a clinician
Additional Effects of Sternocleidomastoid Release With SNAGS in the Management of Cervicogenic Headache

Cervicogenic headache is a common type of headache in adults which causes disability and difficulty in everyday activities. According to the latest International Headache Society model, cervicogenic headache (CGH) is a secondary headache having C1-C2 dysfunction. SNAGs are highly effective in the treatment approach for these patients. Sternocleidomastoid muscle receive overactive tension from forward neck posture, increasing muscular fatigue and tone of muscles. This tension in SCM causes referred pain in the head and neck region. SNAGs are very effective but musculoskeletal impairments especially the tightness of sternocleidomastoid muscle still persist and can exacerbate symptoms. Manual therapy targeted to the SCM muscle may be effective for reducing headache and neck pain intensity and increasing performance of deep cervical flexors. Findings of this study will aid the therapists in choosing which technique to use while treating the patients. This will save therapist's time and effort as they will not be using the less effective treatment protocol. Furthermore, patient's time and investment will be used in the right direction.


Eligibility Criteria:
Inclusion Criteria:

* Age group: 18-45 years old
* Both males and females
* Unilateral headache with no shift of side
* C1-C2 Dysfunction
* Positive flexion rotation test (Rotation restriction is greater than 10 degrees)
* Headache at least once a month in the last 3 months
* Headache with at least 4 score in NPRS (Sign and Symptoms of Neck Involvement)
* Headache with restriction of ROM in the neck
* Headache precipitated by:

Sustained neck movements, and awkward head positioning. External Pressure over upper cervical or occipital region

Headache Characteristics:

* Moderate-severe, non-throbbing pain, usually starting in the neck.
* Episodes of varying duration, or: fluctuating, continuous pain

Exclusion Criteria:

* Headache of non-cervical origin
* Diagnosed Cases of:Cervical spondylosis,Cervical radiculopathy/ nerve root involvement/ disc herniation,Cervical instability/ fracture,Vertebrobasilar insufficiency ,Cervical spine surgery,Cervical spondylolisthesis,Spinal infection or tumors,Osteoporosis,History of trauma,Rheumatoid Arthritis,Inflammatory Arthritis
Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone

The purpose of this study is to compare ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone

While there are some retrospective studies compared ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone, there is not randomized clinical trial in this regard. This study was designed to compare the efficacy and safety of ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone

Eligibility Criteria:
Inclusion Criteria:

* ureteral stone who underwent ureteroscopy

Exclusion Criteria:

* transplant kidney
* coagulopathy disorders
* history of ureteral stenosis
* skeletal disorders
Evaluation of the Efficacy of the ALLYANE Procedure in the Treatment of Central Motor Inhibition

The goal of this clinical study is to determine the effectiveness of restoring muscle strength in the management of motor inhibition when complemented by the ALLYANE process (neuro-motor reprogramming) compared to a standard management approach.

The main questions it aims to answer are:

* Does the ALLYANE process lead to greater muscle strength gains compared to standard care?
* Is there a functional benefit when standard management is complemented by the ALLYANE process?

The investigators will compare the group receiving standard care complemented by ALLYANE to a group receiving only standard care to evaluate if the ALLYANE process provides additional effects.

Participants will:

* Undergo assessments of muscle strength.
* Receive either standard management or standard management with ALLYANE.
* Complete functional evaluations before and after treatment.

This study aims to evaluate the effectiveness of motor inhibition management using two different approaches: standard management alone and standard management supplemented by the ALLYANE neuro-motor reprogramming process. To ensure robust and reliable results, the study proposes enrolling a total of 120 patients, divided into two groups of 60 patients each.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 35 years
* No neurological history
* Have had a primary knee sprain
* Present with VMO lateralisation with or without the presence of flessum
* Quadricipital weakness between the healthy and injured limb of 50% or more as measured by a portable dynamometer
* Member of a social security scheme

Exclusion Criteria:

* Recurrent sprain
* Bilateral sprain
* Persons under guardianship, trusteeship or any other measure depriving them of their rights or liberty, and adults protected by law.
* Persons who do not understand French
* Knee trauma other than sprain
* Exclusion criteria for the Allyane procedure (COPHOSIS, cognitive difficulties, purely mechanical limitation)
* Algodystrophy
Salt Sensitivity, Cardiovascular and Metabolic Disease

To identify the role of salt-sensitivity of blood pressure in the pathogenesis of hypertension.

DESIGN NARRATIVE:

Approximately 498 of 750 normal and hypertensive subjects who were carefully characterized in terms of blood pressure response to salt loading and depletion in the late 1970s were re-examined to identify physiological factors contributing to salt-sensitivity of blood pressure. This helped to confirm preliminary observations suggesting that salt sensitivity in normotensive subjects predicted the subsequent development of hypertension with aging. In addition, longitudinal observations in hypertensive patients and in normotensives helped to determine whether salt-sensitivity or salt-resistance of blood pressure were associated with differences in the risk for development of specific forms of cardiovascular disease (stroke, angina, myocardial infarction, congestive heart failure), renal and metabolic (diabetes mellitus) disorders.

Eligibility Criteria:
No eligibility criteria