cyrilzakka/clinical-trials huggingface dataset:
Return to Work in Patients With Chronic Pain

This study aims to evaluate whether a vocational behaviour change ability programme has any additional effect on return to work compared with return to work coordination only in persons with chronic pain.

New vocational rehabilitation models including the workplace are urgently needed for persons with chronic pain.

Return to work coordination means external and internal coordination regarding sick leave by help of a rehabilitation coordinator from health care. The goal is to establish a common return to work plan between employer and employee as dictated by Swedish law. The hypothesis is that return to work coordination is not sufficient. Additional effects on return to work and work ability from a behaviour change ability programme aiming to enhance work ability by targeting context at the workplace, physical and psychological functioning, and behavioral skills at work are expected.

The hypothesis is tested in a randomised controlled trial. Before the start of the trial a series of 3-6 experimental single case studies will be performed to study the implementation of the interventions more thoroughly.

Eligibility Criteria:
Inclusion Criteria:

* Chronic pain with a duration for more than 3 months
* On sick-leave 25%-100% from salaried employment or studies, for at least 30 days
* Identified employer or director of studies
* Ability to understand, speak, and write Swedish

Exclusion Criteria:

* Severe substance use disorder
* Severe psychiatric illness
* Recruited participants with employers who does not consent to participate
Use of Loop Recorders for Diagnosis of Palpitations in A&E

Heart rhythm abnormalities underlie one of the common presenting complaints to the A\&E and out-patient departments, specifically awareness of heart beats or palpitations. Unless an ECG (electrocardiogram) tracing of the heart rhythm can be recorded while the patient is having symptoms, it is very difficult to determine the cause of the palpitations. The conventional approach is to refer these patients from the emergency departments to the Cardiology outpatients where they undergo repeated short term rhythm monitoring hoping to record the rhythm underlying the patient's complaint. Unfortunately, this often yields no results thus delaying definitive treatment and incurring extra costs of repeated investigations and A\&E presentations. This study aims to compare the ability of the conventional approach to establish a definite diagnosis compared to that of an early invasive monitoring approach with a small implantable device that records the heart rhythm at all time for up to 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Good history of episodic symptomatic sustained palpitations (sudden onset and offset, fast heart beats, may be associated with shortness of breath or dizziness)
* Terminates before presentation to hospital
* Episodes occur at a frequency of less than once every two weeks
* Never previously caught on ECG or ambulatory monitoring
* Normal resting ECG

Exclusion Criteria:

* Contraindication to ILR implantation i.e. ongoing oral anticoagulation with INR \>1.6, ongoing infection, sepsis or fever, etc.
* Palpitations suggestive of extrasystoles (single missed or dropped beats)
* Known or suspected severe valvular or myocardial heart disease

  * An audible heart murmur
  * Any abnormality on the surface ECG
* Thyrotoxicosis
* Patients who refuse an ILR when offered will not be included in either limb of the study
The Relationship Between Posture, Sense of Position, Musculoskeletal Discomfort and Anxiety

It is known that posture is affected by various factors such as somatosensation, visual perception and cognition. In addition, it is also thought to affect conditions such as stress and anxiety through receptors. The aim of this study was to investigate the relationship between postural changes such as thoracic kyphosis, musculoskeletal problems, trunk position sense and anxiety in young individuals who were asymptomatic in terms of musculoskeletal problems.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Volunteered to participate in the study
* No systemic or neurological disease

Exclusion Criteria:

* Severe visual and hearing problems
* Orthopedic injury or surgery in the last 6 months
Bioequivalence Study of Topiramate Tablets 25mg Under Fed Conditions

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg topiramate tablets following a 50 mg dose under fed conditions.

This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 18 healthy adult male volunteers. A total of 17 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 24-hour blood draw. Subjects were to return for the 48-, 72-, 96- and 120-hour blood draws. Both periods were separated by a washout period of 14 days.

Eligibility Criteria:
Inclusion Criteria:

1. This study involved healthy adult male volunteers, 18-45 years of age, weighing at least 52 kg, who are within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
2. Only medically healthy subjects with clinically normal laboratory profiles were enrolled in the study.

Exclusion Criteria:

1. History or presence of significant:

   * cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

   In addition, history or presence of:
   * hypersensitivity or idiosyncratic reaction to topiramate;
   * nephrolithiasis or gout;
   * alcoholism or drug abuse within the past year.
2. Subjects who had been on an abnormal diet (for whatever reason) during the 28 days preceding the study.
3. Subjects who had used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days of study start.
4. Subjects who had used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days of study start.
5. Subjects who, through completion of the study, would have donated in excess of:

   * 500 mL of blood in 14 days, or
   * 500- 750 mL of blood in 14 days (unless approved by the Principal Investigator),
   * 1000 ml. of blood in 90 days,
   * 1250 mL of blood in 120 days,
   * 1500 mL of blood in 180 days,
   * 2000 mL of blood in 270 days,
   * 2500 mL of blood in 1 year.
6. Subjects who have participated in another clinical trial within 28 days of study start.
The Use of Manual Therapy to Treat Low-Back and Hip Pain

Low back pain (LBP) is a common problem in the adult population with many approaches to treatment, but no clear answer. One of the causes of LBP, musculoskeletal pain, can be triggered by spasm of the deep muscles of the back and pelvis. This study, therefore, focuses on treating pelvic muscle pain as a way of lessening LBP.

Osteopathic manipulative medicine (OMM) is a well-researched standard of care in the treatment of low back pain (LBP). Under the heading of OMM, many different modalities exist to decrease a patient's somatic dysfunction. Among the most commonly used are high velocity (thrusting through an immobilized joint) and muscle energy (engaging a restrictive barrier using the patient's own strength).

Although a very common complaint, there is no exact etiology for LBP. Many different theories exist, including postural disturbances, leg length discrepancies, and even genetic predispositions. A study in Spine finds that among those with chronic LBP there is a subgroup of people with reduced hip flexion, and concludes that hip motion should be considered in treatment of patients with LBP. Currently, there exists no research on the manipulation of hip flexors in the treatment of LBP. This study, therefore, will test the efficacy of OMM on the deep pelvic musculature as a way of decreasing LBP.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age-older than 18 years and younger than 65 years
* Lumbopelvic pain

Exclusion Criteria:

* Cardiovascular disease (heart-failure, myocardial infarction, hypertension)
* Diabetes
* Rheumatoid Arthritis
* Osteoarthritis
* Chronic Illness
* Pregnancy-self reported
* Neurodegenerative Disease
* Osteopenia
* Osteoporosis
* Metastatic Cancer
A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia

This is a randomized, double-blind, placebo-controlled, multicenter, multiple ascending dose (MAD) study to evaluate the safety and tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of HTD1801 in overweight to obese adults with hypercholesterolemia. There were 3 cohorts of dose levels as 500, 1000 and 2000 mg/day, with 16 subjects planned for each cohort randomized 3:1 to receive either HTD1801 or Placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Males or females aged 18 to 70 years old at the time of first dosing
3. Have a body mass index (BMI) of \>25.0 and ≤ 45.0 kg/m2 at Screening
4. Have a documented history of hypercholesterolemia, defined as LDL-C ≥ 2.59 mmol/L

Exclusion Criteria:

1. The use of any anti-dyslipidemia agent within 28 days prior to dosing
2. History of a total cholesterol ≥ 10.35 mmol/L or triglyceride ≥ 11.3 mmol/L
3. History of a clinically significant cardiac arrhythmia or clinically significant abnormal ECG results at Screening
4. Significant peripheral or coronary vascular disease
5. Clinically significant abnormal blood pressure at Screening or Baseline, defined as supine blood pressure ≥160/100 mmHg, or ≤ 90/60 mmHg
6. Primary hypothyroidism (thyroid stimulating hormone \[TSH\] \> upper limit or normal \[ULN\] and free T4 \< lower limit of normal \[LLN\]), primary subclinical hypothyroidism (screening TSH \> ULN and free T4 within normal limits \[WNL\]), or secondary hypothyroidism (screening TSH \< LLN and free T4\< LLN) at Screening
7. Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Automated EDSS Score Calculation by Smartphone Application

The EDSS score is the reference tool for rating disability in patients with multiple sclerosis. It is used in both daily monitoring and clinical research studies.

Its main shortcoming lies in its imprecise and variable nature, with significant inter-examiner variability. This variability is the consequence of the complexity of the score rating and also of its subjective nature.

The application developed aims to reduce the risk of rating error, and to homogenize the results obtained regardless of the examiner and his experience in using the score.


Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple sclerosis seen at the Central Nervous System Day Hospital as part of their follow-up and requiring neurological examination.
* Age ≥ 18 years
* No opposition to the use of their data

Exclusion Criteria:

- Neurological or general pathology, other than multiple sclerosis, that may interfere with EDSS score scoring
A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects with Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen

A Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat an aldosterone synthase inhibitor (ASI), administered as an add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.

This study is a Phase 2 trial to evaluate the blood pressure-lowering effects of lorundrostat (an ASI), administered as add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.

The study consists of a standardized AHT regimen run-in period followed by a randomized, double-blind, placebo-controlled, parallel arm period. Following the double-blind period subjects may be offered the opportunity to participate in an open-label extension (OLE) study. Subjects electing to not participate in the OLE will undergo an end of study (EoS) visit approximately 2 weeks after the last dose of study drug to complete their participation in the study.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age at the time of signing the informed consent form
2. At Screening: AOBP SBP of 140-180 mmHg and AOBP DBP of 65-110 mmHg, or AOBP DBP of 90-110 mmHg
3. 24-hour average ABPM SBP of 130-180 mmHg or 24-hour average ABPM DBP \>80 mmHg
4. Taking between 2 and 5 AHT medications, inclusive, at Screening visit.
5. BMI of 18-40 kg/m2 inclusive at Screening

Exclusion Criteria:

1. eGFR \<45 mL/min/1.73 m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
2. Serum potassium \>5.0 mmol/L at Screening or \>4.8 mmol/L at Randomization
3. Serum sodium \<135 mmol/L at Screening
4. History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to Screening.
5. Diabetes mellitus with a glycosylated hemoglobin (HbA1c) \>9% (\>74.9 mmol/mol) at Screening
Otago Exercise in Patient With Total Knee Replacement

To determine the effect of Otago exercise in Total Knee Replacement

Degenerative knee arthritis is one of the most common diseases in the elderly population. Age is the strongest risk factor for osteoarthritis. The 2010 Global Burden of Disease Study reports that the burden of musculoskeletal disorders is much larger than estimated in previous assessments and accounts for 6.8% of daily worldwide. An estimated 10% to 15% of all adults aged over 60 have some degree of OA. In Pakistan, 3.6% in rural and 3.1-4.6% in urban parts of Pakistan were found diagnosed by knee OA.

When conservative treatments fail to control the symptoms, joint replacement is performed. Specifically, more than 1 million surgeries are performed every year in the United States (US) alone, with a total expenditure close to 13.7 billion and 28.5 billion US dollars for the hips and knees, respectively. The demand is expected to increase by approximately 4 time by the year 2030 annually more than 4000 joint have been replaced in Pakistan." Overall, the progress of patients after joint replacement is satisfactory. Nevertheless, a substantial number may present with functional and balance limitations, even 1 year after surgery.

A cross sectional study reported that a Home-based balance and strength exercises (OEP) benefited older fallers with OA and gait and balance disorders by improving postural control. Another study has been done which suggested that elderly people who performed the OEP showed an increase in balance, muscle strength, and a decrease in both fall percentage and fall frequency. Evidence has recommended that, the OEP was more effective improving functional balance, muscle strength and physical health.

A cross sectional study was conducted to evaluate the influence of specific balance-targeted training on the overall state of balance in older adults undergoing TKR. They concluded that the additional balance training program improved balance performance to a higher extent than a control group.

After surgery, pain and stiffness are remarkably relieved, but functional and proprioceptive deficits, including limitation of lower limb mobility, difficulties in walking, and alterations instability and balance may remain. However, the effect of Otago exercise on balance are present in literature but the evidence for their influence in patients with TKR is narrow. So aim of this study to identify the possible role of Otago exercise program in particular population (TKR) and the prognosis in balance and Gait with this protocol in patients undergoing TKR.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate
* Participants who undergo unilateral cemented knee replacement due to arthritis

Exclusion Criteria:

* Uncontrolled Hypertension
* Lower extremity impairment that can limit the patient's function
* Patient with neurological and cognitive impairment
A Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands

This is a multicenter, prospective, non-interventional, observational single arm study.

100 patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the Summary of Product Characteristics (SPC) of apremilast (Otezla®). Each patient will be followed up for a maximum of 24 months.

The objective of this non-interventional study is to describe patient reported outcomes, effectiveness and real-life use of apremilast treatment in patients with psoriatic arthritis (PsA).

Eligibility Criteria:
Inclusion Criter

* Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form.
* Patients starting treatment with apremilast for psoriatic arthritis.

Exclusion Criteria:

* Refusal to participate in the study.
* Language barrier for completing the questionnaires.
* Women who are pregnant or breast-feeding.
* Hypersensitivity to the active substance or to any of the excipients.
* Prior exposure to apremilast
* Initiation of apremilast treatment by a dermatologist for psoriasis
A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide

The primary objective of the study was to study the safety and tolerability of teduglutide following a once or possibly twice daily subcutaneous injection for eight consecutive days in healthy subjects. A secondary objective was to study the pharmacokinetics of teduglutide following a once or possibly twice daily injection for eight consecutive days in healthy subjects.

Healthy subjects are enrolled once they have been screened and it is determined they qualify. The subjects are randomized to either placebo or the dose of teduglutide as outlined by the protocol at a 1:3 ratio. They will be injected with investigational product for eight consecutive days, with measurements taken including safety.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 20 and 55 years of age
* BMI of 18-35 inclusive
* Able to understand and sign informed consent form
* Willing and able to be confined at the clinical research center 8.5 days
* Women who are post-menopausal, surgically sterilized, or agree to use effective form of birth control
* Women of child bearing potential with a negative pregnancy test at screening and check-in
* Medically healthy with normal clinical results and ECG/lab profiles at screening and check-in

Exclusion Criteria

* Donated 1 pint or more of blood/blood products within 56 days prior to study or received plasma within 7 days prior to study
* Pregnancy or become pregnant
* Participated in another investigational trial 30 days prior
* Physical examination/medical history indicates clinical condition or concurrent illness unsuitable for study
* History/presence of clincally significant disease of any body system
* History/evidence of congenital hon-hemolytic hyperbilirubinemia
* History/evidence of gall stone disease, stomach or intestinal surgery
* History/evidence of colorectal cancer
* History/evidence of GI disease, e.g., malabsorption, Crohn's Disease, etc.
* History/evidence of skin rashes or dermatitis
* Taking prescription or over the counter medication (with the exception of oral contraception) during the 7 days preceding confinement to the clinical unit
Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes Test

This is a multicenter, cross-sectional study. It is based on fecal methylation site detection, H. pylori susceptibility testing of fecal samples, and a combination of the two, compared with the "gold standard" imaging tests, CT, gastroscopy and/or pathology, for gastric cancer, benign diseases such as gastritis, and health check-ups.

Primary study objective: to evaluate the sensitivity and specificity of fecal methylation site-based and fecal Helicobacter pylori gastric cancer susceptibility gene assays applied to early diagnosis and screening of gastric cancer.

Secondary research objectives: 1. the accuracy, kappa value, area under the ROC curve, positive likelihood ratio, negative likelihood ratio, positive predictive value, and negative predictive value of fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing applied for predicting gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumor markers, such as CA19-9, CEA, and CA72-4; and 3. the follow up of Gastritis and healthy people, to assess the cases of gastric cancer during the follow-up period and the clinical diagnosis and treatment prediction; 4. Follow-up gastric cancer patients, to assess the association with gastric cancer recurrence metastasis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years, male or female.
* Have or will have gastroscopy and/or pathology results.
* No contraindications to endoscopy and able to cooperate with endoscopy.
* Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.

Exclusion Criteria:

* Severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders.
* A previous history of malignant tumors of the upper gastrointestinal tract.
* Women during pregnancy.
* Those with undefined pathology.
* Those with unsatisfactory sample retention (e.g., too small a sample size)
Treatment Decision-Making Among Patients Diagnosed With Papillary Microcarcinoma and Their Significant Others

The purpose of this study is to understand more about why some patients choose to have surgery to treat their papillary microcarcinoma (PMC) and others choose to have their papillary microcarcinoma (PMC) regularly watched by their doctor to see if and when they may need surgery (referred to as "active surveillance"). The investigators also hope learn more about what patients and their family members worry about or feel they will gain from surgery or active surveillance.


Eligibility Criteria:
Inclusion Criteria:

Thyroid cancer patient eligibility will include:

* Thyroid cancer patients who have been diagnosed with papillary microcarcinoma (or subcentimeter thyroid lesions with fine needle aspiration biopsy suspicious for papillary or follicular thyroid cancer) within the prior 6-12 months as per EMR path report and clinician assessment;
* Presented with the option of treating their papillary microcarcinomas with either surgery or active surveillance as per treating physician;
* English-fluent;
* 18 years of age or older;

Patient-designated significant other eligibility will include:

* Nomination by patient as individual who assisted patient in decision-making regarding how to treat thyroid papillary microcarcinoma;
* English-fluent;
* 18 years of age or older;

Exclusion Criteria:

Thyroid cancer patient exclusion criteria will include:

* Thyroid cancer patients with known loco-regional or distant metastases prior to initial surgical intervention as per path report.