cyrilzakka/clinical-trials huggingface dataset:
Optimal Treatment of Plantar Fasciitis: Physical Training, Glucocorticoid Injections or a Combination Thereof.

The purpose of this study is to determine whether reduced load to patients with plantar fasciitis (reduced standing, walking, landing) together with either controlled heavy resistance training or glucocorticosteroid injection or a combination thereof is the best treatment.

Plantar fasciitis (PF) is a frequently diagnosed condition, defined as pain at the medial tubercle of the calcaneus, and 10% of the population will at some points in their life experience this condition. Accumulated loading of the plantar fascia seems to relate to development of PF, as it is commonly seen in runners and those who are overweight, and number of daily steps or simply time of standing has been shown to be a predisposing factor for PF development.

Orthosis and glucocorticoid injections are 2 widely used treatments with proven effect. However treatment of overuse injury in other tendon/aponeurosis-like structures, has over the later years been dominated by an increasing documentation of a good curative effect of heavy controlled mechanical loading (eccentric strength exercises or heavy slow concentric strength training) upon tendinopathies in Achilles or patella tendon. However, no studies have looked at the influence of physical training (e.g. strength training) on the diseased plantar aponeurosis. Also no studies have looked at the effect of a combination of giving local glucocorticoid injection and training on this or other tendon overuse entities.

We hypothesize that heavy strength training will have a positive effect upon PF, and that a combination of training and glucocorticoid injections will have an additive effect upon this disease and be even more effective than each of the treatments alone. Glucocorticoid injection acting as the standard control treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pain at the medial attachment of fascia plantaris.
* First step pain in the morning
* Symptoms for at least 3 months.
* Age 20-65 years
* Ultrasound scanning at the first visit shows thickness of the fascia above 4 mm.
* Patient can read and understand danish

Exclusion Criteria:

* known arthritis, inflammatory bowl disease, psoriasis or clinical signs of any of these
* Leg ulcerations
* Longlasting oedema of the leg and foot
* Palpatory decreased puls in the foot
* Diabetes
* Reduced sensibility in the foot
* Infections in the foot
* Daily use of pain killers
* Pregnancy or planning to become pregnant
* Earlier operations on the foot, that is judged to complicate training
* Patient assessed not to be able to participate in the training for other reasons
* Glucocorticosteroid injection to the diseased plantar fascia within the last 6 months.
Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium

The purpose of the research is to see if dexmedetomidine (a drug that has a calming effect - a sedative) is effective for the treatment of acute delirium

Delirium is a mental disturbance that causes people to be confused and restless for a period of time. We will compare dexmedetomidine to the traditional therapy for treatment of acute delirium. Dexmedetomidine does not affect breathing. The traditional drugs might make one sleepy and may slow down breathing. The traditional therapy in this institution for acute delirium is _the use of Haloperidol, and/or benzodiazepines. Haloperidol is an antipsychotic drug that has calming effect. Benzodiazepines are sedatives with calming effect.Dexmedetomidine is approved by the Food and drug Administration (FDA) to sedate patients on a breathing machine for 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Adults admitted to our surgical ICU who do not have any exclusion criteria
* Eligibility for treatment- Development of delirium as defined

Exclusion Criteria:

* Acute MI (myocardial infarction),
* Trauma \<24 hours,
* Head injury,
* Multiple organ failure,
* EF (ejection fraction) \< 30%,
* History of hypersensitivity to alpha2 agonist,
* History of seizures, MAP (mean arterial pressure) \<60 mm of Hg,
* Dysrhythmias a/with bradycardia (HR (heart rate) \<50),
* Need for vasopressors,
* Acute renal failure with a need for dialysis/CVVH (Continuous Veno-Venous Hemofiltration) or liver disease.
* Women of child bearing age who do not have a documented negative pregnancy test and/or who do not actively use contraception. (Documented negative pregnancy test will be a urine pregnancy test obtained on this admission)
Rollover Protocol Continued Access to Tenofovir Disoproxil Fumarate (TDF) for Subjects in Taiwan

The purpose of this study is to offer subjects from centers in Taiwan who successfully complete 168 weeks of treatment in study GS US 174-0108 access to treatment with tenofovir DF for up to three additional years (144 weeks). Subjects will be followed per local standard of care. Serious adverse events (SAEs), drug accountability and patient disposition will be recorded.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

* Complete all end of study visit procedures for the GS US 174-0108 study.
* Willing and able to provide written informed consent.
* A negative pregnancy test is required for female subjects at the end of study visit (i.e., screening visit for study GS-US-174-0141) for GS US 174-0108 (unless surgically sterile or greater than two years post-menopausal)
* All sexually active female subjects who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study.
* Male subjects who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion.

Exclusion Criteria:

• Not Applicable
Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer

A single-site study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive \& HER2-negative after capecitabine-base chemotherapy.

Capecitabine-base chemotherapy must be ≥Second-line Therapy

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* The age is Above 18 years of age, \<70 years old
* HR-positive \& HER2-negative
* Metastatic breast cancer,incurable.
* For recurrent or metastatic lesions has had at least 1 but no more than 3 kinds of chemotherapy, if there is disease progression within 6 months after the end of the adjuvant chemotherapy, adjuvant chemotherapy will been the first-line treatment for metastatic lesions
* No prior use of capecitabine therapy or the use of capecitabine treatment was effective, and the efficacy evaluation was CR/PR/SD more than 6 months.
* Eastern Cooperative Oncology Group performance status (ECOG PS)=0\~1
* The basic function of normal bone marrow
* Functions of liver and kidney is normal
* Expectation of life is more than 3 months
* Agreed to take contraceptive measures during treatment

Exclusion Criteria:

* Previous toxicity was not recovered to 0-1 degrees
* Central nervous system metastasis
* Pregnancy or lactation
* There are uncontrolled infection, myocardial infarction, thrombosis, etc.
* There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease;
* Researchers believe that is not suitable for the study
* Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix;
* Bilateral breast cancer
* Capecitabine was ineffective in past treatment
Fluid Overload in Peritoneal Dialysis

The objective of this study is to determine the effectiveness of treating peritoneal dialysis (PD) patients with fluid overload by a structured nurse-lead intervention protocol. We plan to recruit 100 PD patients with fluid overload. These patients will be assessed and managed by a renal nurse specialist in the ambulatory renal center according to a standardized protocol. The improvement in the degree of overhydration will be determined by bioimpedance spectroscopy 4 and 12 weeks after treatment.

Fluid overload is a common problem in peritoneal dialysis (PD) patients and it is associated with left ventricular hypertrophy and other adverse cardiac consequences. Fluid management is therefore an important aspect in the management of dialysis patient. In Hong Kong, PD patients with common medical problems related to dialysis are assessed and managed in the renal nurse clinic by pre-approved intervention protocols. Although it is the general impression that management of PD patients with fluid overload by a nurse-lead intervention protocol is robust and could reduce the work load of medical staff, the efficacy of this approach remains undetermined. The objective of this study is to determine the effectiveness of treating PD patients with fluid overload by a structured nurse-lead intervention protocol. We plan to recruit 100 PD patients with fluid overload, which is defined as overhydration (OH) ≥ 2 litres as measured by bioimpedance spectroscopy. These patients will be assessed and managed by a renal nurse specialist in the ambulatory renal center according to a standardized protocol previously approved by the Hospital Authority. The improvement in the degree of overhydration will be determined by bioimpedance spectroscopy 4 and 12 weeks after treatment. Change in body weight, blood pressure, degree of oedema, as well as the knowledge on salt and fluid restriction will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* PD patients with overhydration (OH) ≥ 2 litres as measured by bioimpedance spectroscopy

Exclusion Criteria:

* overt pulmonary edema and required urgent medical care
* cognitive impairment or problem of communication
* unlikely to survive for more than three months
* mechanical problems of the dialysis catheter
* active peritonitis or peritoneal failure
Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors

Researchers are gathering information to see if using an FDA approved implantable device can help with monitoring of your heart arrhythmias.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac biopsy or technetium pyrophosphate scintigraphy confirmed patients
* Stage I, II, and early and late stage III in numbers as described , irrespective of EF or NYHA functional class
* Patients aged 18 -85, both genders and of all races and ethnicities.
* Patients must be competent to give informed consent.
* Patients must be able to have the Biomonitor 3 implanted.
* Amyloid stage I-III patients with existing implantable cardiac devices such as pacemakers or defibrillators

Exclusion Criteria:

* Significant coronary artery disease \> 75% luminal stenosis in at least 1 epicardial vessel (by cardiac catheterization or coronary computed tomography), or history of myocardial infarction or coronary revascularization.
* Congenital heart disease.
* Pregnant patients
* Patients whose heart failure is felt to be secondary to primary valvular disease (\>moderate/severe mitral regurgitation), uncorrected thyroid disease, obstructive or hypertrophic cardiomyopathy, pericardial disease or a systemic illness.
* Absolute contraindications to cardiac MRI (such as renal failure with GFR\<30%).
* Unwilling or unable to provide informed consent.
* Patients with other life threatening diseases that would likely decrease their life expectancy over the next four years.
* Patients who are post cardiac transplant.
* Difficulty to attend the follow-up schedule due to a history of medical noncompliance, difficulty, or unwillingness to return to the study center for follow up.
* Evidence of ongoing bacteremia or sepsis preventing implantation of a device
* Unwilling or able to have the Biomonitor 3 interrogated
Belgian Drug-utilization Study to Evaluate the Use of VIMPAT® as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older

Observational study at the request of the Belgian Institut National d'Assurance Maladie-Invalidité / Rijksinstituut voor Ziekte-en Invaliditeits Verzekering INAMI/RIZIV:

* type of patient treated with VIMPAT®
* VIMPAT® dose
* Effect of VIMPAT® on evolution of seizure control
* Persistence rate at 6 months in terms of treatment duration
* Discontinuation rate
* Description of any changes in other epilepsy therapies
* Safety and tolerability


Eligibility Criteria:
Inclusion Criteria:

* An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form
* Subject/legal representative is considered reliable and capable of adhering to the medication intake according to the judgement of the investigator
* Based on the investigators clinical judgement, the subjects' seizure activity is uncontrolled on current therapy and it is in the subjects' best interest to be prescribed an antiepileptic drug (AED) as adjunctive therapy. The choice to prescribe VIMPAT® as adjunctive therapy is made by the treating investigator
* The subject is aged 16 or older
* The subject has a diagnosis of epilepsy with partial-onset seizures according to the label
* The subject has a medication history with at least 3 AED therapies (lifetime and/or concomitant) with treatment failure: due to insufficient efficacy, due to significant adverse events
* Sufficient data on the clinical situation before start of VIMPAT® and information on VIMPAT® dosing are present in the subject's medical record for patients on treatment with VIMPAT® at the time of enrollment into the study

Exclusion Criteria:

* The subject has previously participated in this study or has participated in a clinical trial within the last 2 months
* The subject has a history of chronic alcohol or drug abuse within the last 6 months
* The subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
* The subject has a known hypersensitivity and/or allergy to soya, peanuts, or any component of VIMPAT®
* The subject is pregnant or lactating
* The subject has a known AV-block degree 2 or 3
* The subject is expected to be insufficiently compliant with contraception.
* The subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation
Role of Some Biochemical Indices for Prediction of Acute Kidney Injury in Intensive Care Unit Patients in Upper Egypt

1. We will investigate the relation between the triglyceride-glucose index and the development of AKI in ICU.
2. To detect whether the TGI is a predictor of poor outcome (requirement of renal replacement therapy, or 14-day in-hospital mortality, and length of hospital stay) in ICU.
3. Compare TGL, Neutrophil-to-lymphocyte ratio, and clinical score (sequential organ failure assessment SOFA score) as predictors of poor outcome in ICU.

Acute kidney injury (AKI) is a common clinical syndrome with a broad aetiological profile. It complicates about 5% of hospital admissions and 30% of admissions to intensive care units (ICU). During last 20 years has been a significant change in the spectrum of severe AKI such that it is no longer mostly a single organ phenomenon but rather a complex multisystem clinical problem. mortality from AKI, when part of MOF, remains over 50%.

In the past few decades, the understanding of AKI has greatly improved, but early diagnosis remains a great challenge. The performance of traditional kidney function index and serum creatinine is very limited for the early diagnosis of acute kidney injury The triglyceride glucose index (TGI) has been suggested as a useful marker of insulin resistance. Previous studies have shown that TGI is associated with many diseases, but no study has examined the relationship between TGI and Aki .

the primary objective of the present study was to investigate the relationship between TGI and Aki.

Eligibility Criteria:
Inclusion Criteria:

* The selected patients will be with the following inclusion criteria:

Patients admitted to ICU within 24 hours

Exclusion Criteria:

* We will exclude those with any of the following:

  1. Patients diagnosed more than 24 hours.
  2. Patients with missing data of triglyceride or glucose.
  3. Patients \&amp;amp;lt;18years old.
  4. patient with advanced liver disease and chronic kidney disease with or without dialysis
Alternatives to Manage Dental Fear

This study compares the psychological effects on patients attend the dental clinic by listening to specific audios

Participants of the experimental group listened to Quran recitation using auto-controlled headphones, whereas headphones of the control group participants were silent then the two groups answer questionnaire prepared for this purpose.

Eligibility Criteria:
Inclusion Criteria:

* any patient eligible for dental treatment
* willing to participate

Exclusion Criteria: participants

* less than 18 years of age,
* mentally retarded,
* had hearing impairment or deafness
Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms

This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients with SAH undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.


Eligibility Criteria:
Inclusion Criteria:

* 1. A diagnosis of a ruptured brain aneurysm deemed suitable for repair by neuroendovascular techniques involving intraluminal occlusion by detachable platinum coils, or any neuroendovascular technique such as balloon-assisted coiling, stenting, or flowed diversion.
* 2. Patient should be Grade II-IV on the WFNS grading scale for SAH.
* 3. Male or female with a minimum age of 18 years on the day of enrolment.
* 4. Female subjects of childbearing potential: Negative pregnancy test.
* 5. Non-surgically sterile males or males with partners of childbearing potential must be willing to use condoms with spermicide for 3 months after completion of dosing.
* 6. Body weight less than or equal to 180 kg.
* 7. Vital signs on admission:

  * Blood pressure between 80-180 mm Hg systolic/50-100 mm Hg diastolic;
  * Body temperature ≤ 38.5C.
* 8. Informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements.

Exclusion Criteria:

* 1. Prior SAH within 6 months of presentation.
* 2. Dissecting or mycotic brain aneurysm.
* 3. Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment.
* 4. Known history of life-threatening allergic reaction to any medication.
* 5. Chronic renal disease defined as a baseline serum creatinine \> 150 µmol/L.
* 6. Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test.
* 7. Women who are breastfeeding.
* 8. Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol.
* 9. Pre-morbid (estimated) modified Rankin scale score of \>1.
* 10. Previous major stroke.
* 11. Patients with known HIV infection.
* 12. Participation in a clinical trial with an investigational drug within 30 days preceding this study.
* 13. Previous participation in the ENACT trial (e.g, to treat a prior aneurysm), participation in another trial involving NA-1 or prior receipt of NA-1.
* 14. Any other medical condition that the site investigator deems would put the patient at excessive risk of participation in the study or an expected life expectancy less than 1 year or that would result in inability to collect clinical outcomes at 90 days.
Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

The purpose of this study is to evaluate the efficacy of suvorexant, added to existing medications, for treatment-resistant insomnia in individuals with bipolar disorder. The investigators hypothesize that participants receiving suvorexant for one week will experience significantly greater improvement in sleep duration compared to participants receiving placebo.

Participants will be randomized to receive double-blind suvorexant or placebo for one week, after which all participants will receive open treatment with suvorexant for three months.

Eligibility Criteria:
Inclusion Criteria:

1. Adult outpatients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder (296.70), bipolar II disorder (296.89), or bipolar disorder not otherwise specified (296.80), with concurrent insomnia related to bipolar disorder (307.42).
2. Currently taking ≥ 1 prescription psychotropic medication (hypnotic agents, anxiolytics, atypical antipsychotics, mood stabilizers, and/or antidepressants) for management of bipolar disorder.
3. Subjective total sleep time (sTST) \< 6 hours on ≥ 1 night during the prior week.

Exclusion Criteria:

1. Current hypo/manic symptoms, as evidenced by the Young Mania Rating Scale (YMRS) total score ≥ 12.
2. Current (past 6 months) alcohol or substance use disorder.
3. Current psychosis.
4. Patients who are actively suicidal or evaluated as being a high suicide risk.
5. Women who are currently pregnant or breastfeeding.
6. Clinically significant abnormalities on baseline laboratory tests (comprehensive metabolic panel, fasting lipid panel, Complete Blood Count (CBC) with differential, thyroid stimulating hormone).
7. Presence of any unstable and/or potentially confounding neurological and/or medical disorder.
Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads

The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.

The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. Subsequent to the implantation of the SIELLO leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Meet the indications for pacemaker therapy
* Understand the nature of the procedure
* Give informed consent
* Able to complete all testing required by the clinical protocol
* Available for follow-up visits on a regular basis at the investigational site

Exclusion Criteria:

* Meet none of the pacemaker indications
* Meet one or more of the contraindications
* Have a life expectancy of less than six months
* Cardiac surgery in the next six months -Enrolled in another cardiac clinical investigation- Have other medical devices that may interact with the implanted pacemaker