cyrilzakka/clinical-trials huggingface dataset:
Health Related Quality of Life of Youth and Young Adults With Haemophilia A

Research question:

Whether there are the changes in quality of life in patients with haemophilia A after switching from SHL FVIII prophylaxis to efmoroctocog alfa prophylaxis?

A 12-month prospective open-label, single-arm multicentre study. Evaluation of parameters will be carried out on the backdrop of patient treatment in the settings of routine medical practice. No medical examinations/ procedures/ treatment(s) on the top of regular medical practice are planned, except fixed time of examinations.

Quality of life is among the key factors when medical decision about management of haemophilia is taken. There are no scientific data on the HRQoL in patients after switching from Standard Half Life (SHL) FVIII prophylaxis to efmoroctocog alfa (Extended Half Life, EHL) prophylaxis in Russia.

It will be a 12-month prospective open-label, single-arm multicentre study. Evaluation of parameters will be carried out on the backdrop of patient treatment in the settings of routine medical practice. No medical examinations/ procedures/ treatment(s) on the top of regular medical practice are planned, except fixed time of examinations. Providing the centers/ patients with the study drug (efmoroctocog alfa) may be considered as interventional component, whereas all administrations should be in accordance with Instruction on Medical Use approved by Russian Ministry of Health.

Research question:

Whether there are the changes in quality of life in patients with haemophilia A after switching from SHL FVIII prophylaxis to efmoroctocog alfa prophylaxis?

No hypothesis is formulated for this exploratory study. The obtained data will be used to assess real world data on quality of life and clinical outcomes in patients with haemophilia A after switching from SHL FVIII prophylaxis to efmoroctocog alfa prophylaxis in routine medical practice in Russia

Eligibility Criteria:
Inclusion Criteria:

1. Signed consent form.
2. Adults, adolescents and children (12-25 years old) with haemophilia A with ABR ≥ 2 on at least one-year SHL FVIII prophylaxis.

Exclusion Criteria:

1. Patients who have had hypersensitivity reactions to efmoroctocog alfa or other constituents of the product.
2. History of Factor VIII inhibitors.
3. Patients who have other haemostatic disorders.
4. Patients participating in interventional studies.
Colloid Osmotic Pressure and Osmolality in Hyponatremia

Hyponatremia (serum sodium of less than 135 mmol/L)is a very common electrolyte disorder. The reasons for the disorder varies as well as if it is acute or chronic.

In this study we wish to follow changes in colloid osmotic pressure and osmolality during the initial treatment hours. We also wish to use mass balance for the calculation of body compartments and to detect fluid translocation between these.

Patients with hyponatremia arriving att the intensive care unit are asked to participate in the study. The first blood samples are collected before initializing the treatment as well as measurements of body compartments with a bioimpedance analyzer. Collected blood samples are electrolytes (Sodium, Potassium and Chloride), colloid osmotic pressure, osmolality and hemoglobin. These samples are repeated at 4 and 8 hours after start of the study. Amount of infused fluid as well as electrolytes are recorded. Urine volume is measured and urine samples are analyzed for the loss of electrolytes.

Additional samples for guidance of treatment are collected every hour.

Hopefully the addition of colloid osmotic pressure, osmolality and mass balance can be beneficial in the diagnosis of the reason for the disorder as well as for the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated for Hyponatremia at the intensive care unit.

Exclusion Criteria:

* Circulatory instable patients in need of treatment for more than the hyponatremia.
Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells

This research is being done to understand how changes in DNA may put people at risk for developing coronary artery disease. Stem cells will be made using cells from blood and/or skin biopsy samples. We are trying to understand which specific changes in DNA negatively impact a person's health.


Eligibility Criteria:
Inclusion Criteria:

Cases:

1. Previously enrolled in the CAD module of the Genebank at Scripps Clinic Registry
2. Eligible to have their blood drawn
3. Be reliable, cooperative and willing to comply with all protocol-specified procedures
4. Able to understand and grant informed consent

Controls:

1. Previously enrolled in the Healthy Elderly Active Longevity (HEAL) Cohort
2. Eligible to have their blood drawn
3. Be reliable, cooperative and willing to comply with all protocol-specified procedures
4. Able to understand and grant informed consent

Exclusion Criteria:

1. Unwilling or unable to grant informed consent.
2. Have a significant medical condition that in the Investigator's opinion may interfere with subject's study participation.
Trial of Hypofractionated IMRT Boost Versus Conventional IMRT Boost for Localized High Risk Prostate Cancer

Hypofractionation: 48 Gy in 25 fractions to pelvic lymph nodes while the prostate receives 68 Gy in 25 fractions concomitantly.

Standard Fractionation: pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy over 39 fractions.

Half the participants will receive using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).

The other half of the participants will receive Standard fractionation using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained.
* Histologically confirmed diagnosis of adenocarcinoma of the prostate.
* Clinical stage T1-2 N0 M0, Gleason Score ≤ 7, PSA 20 - 100
* T1-2 N0 M0, Gleason Score 8 - 10, PSA ≤ 100
* T3 N0 M0, any Gleason Score, PSA ≤ 100

Exclusion Criteria:

* Patients with unilateral or bilateral hip replacement.
* Patients with active collagen vascular disease.
* Patients with active inflammatory bowel disease.
* Patients with previous radiotherapy to the pelvis.
* Patients with ataxia telangiectasia.
* Patients with nodal or distant metastases
The Use of Adaptive Proximal Scaphoid Implant (APSI): Long Term Follow-up

Scaphoid proximal pole fracture with avascular necrosis is a complex surgical problem. In some cases, it's possible to perform a scaphoid hemiarthroplasty with an adaptative proximal scaphoid implant (APSI), made of pyrocarbon, replacing the necrotic proximal pole. APSI allows an early mobilization of the wrist, an optimal recovery of strength and a rapid return to normal daily and work activities without limitations. This implant delays palliative and more invasive surgical treatments in patients that are generally young with high functional demands. The investigators have performed a long-term follow up (with a mean follow-up of 17 years) of the early cases of APSI implant performed, starting from 1999. Radiographic and clinical strength recovery, along with subjective outcomes, have been shown to be good, with a rapid return to daily and work activities, indicating that APSI implants are a good alternative to traditional and invasive techniques.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent APSI implant surgery in the period from December 1999 to December 2016, with surgery performed via dorsal or volar approach in the case of previous surgical access;
* collection of informed consent to the processing of personal data by the Patients contacted in order to be included in the study.

Exclusion Criteria:

* patients for whom it was not possible to obtain informed consent to the processing of personal data.
Effects of Neuromuscular Electrical Stimulation on Flexor Spasticity and Function in Stroke Patients

In this study, the investigators aimed to determine the effects of botulinum neurotoxin type A injections for wrist and finger flexor spasticity and neuromuscular electrical stimulation therapy applied to wrist and finger flexors or extensors on upper extremity flexor spasticity and function in stroke patients.

Neuromuscular electrical stimulation therapy applied to wrist and finger flexors (agonist application) or wrist and finger extensors (antagonist application) after botulinum neurotoxin type A injections in stroke patients with wrist and finger flexor spasticity in upper extremity flexor spasticity, To determine the effects on motor recovery, upper extremity and hand functions, hand grip strength, range of motion, functional independence, quality of life, hand skills and sonographically evaluated muscle thickness and to compare these different applications.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with ischemic or hemorhagic stroke after imaging with CT/MRI
2. First time stroke survivor
3. between 45-75 years old
4. Stroke duration \> 3 months
5. Neurologically stable
6. Affected wrist and finger flexor muscle spasticity with MAS≥2
7. Patients whose cognitive status is at a level to understand the study instructions MMT\> 23)

Exclusion Criteria:

1. Presence of another neurological disorder other than stroke causing motor impairment/spasticity
2. Fixed contracture in the hand-wrist
3. Use of medical treatment for spasticity
4. Having received neurolytic therapy, BoNT-A injection or NMES treatment in the last 3 months
5. Skin problem (disease, allergy, infection, etc.) on the contact surface of the NMES
6. Complex regional pain syndrome (CRPS), sequelae of previous trauma or surgery (muscle tendon adhesion, peripheral nerve damage) in the affected extremity
7. Having a pacemaker
8. Epilepsy
9. Malignancy
Photobiomodulation Therapy for Idiopathic Facial Paralysis

Objective:

Bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. Without treatment, 30% of patients with complete paralysis will not completely recover. Therefore, shortening the recovery time will accelerate the recovery process leading to better results.

The objective of this study was to determine whether photobiomodulation therapy with laser acupuncture therapy could relieve symptoms in patients with Bell's palsy.

Methods:

This study was an open-label, randomized controlled trial including 96 patients that undergoing Bell's palsy. All the patients received oral vitamin B1.

Patients were assigned to the laser acupuncture (LA) group and control group, with 102 patients in each group. LA group were received 4 weeks of Laser treatment (3 times per week), while control group were received sham laser treatment.

Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), and electrophysiological testing, including Electroneuronography (ENoG), Electromyography (EMG) and Blink Reflex. All the measurements were collected at the first day and at the end of study. All reported P values were two-sided and were declared statistically significant when less than 0.05.


Eligibility Criteria:
Inclusion Criteria:

* (1) Clinical diagnosis of Bell's Palsy. (2) Adults over 18 years of age and under 60 years of age.

Exclusion Criteria:

- (1) Systemic disease, such as severe diabetes, malignant tumors and other serious consumptive diseases.

(2) Serious mental illness or social problems, and neurological disorders. (3) Planning for pregnancy, in pregnancy or lactation.
A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence

The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Females 18 to 75 years of age
* Has reported symptoms of urge urinary incontinence/overactive bladder

Exclusion Criteria:

* Is pregnant or lactating
* Has had lower urinary tract surgery within 6 months prior to Screening
* Has a history of urinary retention
Serum Lactate in Convulsive Syncopes Compared to Non-convulsive Syncopes

The investigators compared the serum lactate, serum prolactin and serum creatine kinase concentrations following convulsive and non-convulsive syncopes. The aim of the study was to investigate their importance as diagnostic markers in transient loss of consciousness.

Unclear transient loss of consciousness is a frequent interdisciplinary diagnostic problem. Of particular importance is the distinction between epileptic and non-epileptic events. Our group showed in two previous studies that serum lactate is elevated in epileptic seizures, but mostly not in syncopes, psychogenic non-epileptic seizures and complex partial seizures. These results showed that lactate can be used as a diagnostic marker for the presence of a generalized epileptic seizure.It remains unclear whether a normal serum lactate value is also present in a convulsive syncope as the most important differential diagnosis to generalized epileptic seizures.

So in the present prospective study, the serum lactate concentrations are compared following convulsive and non-convulsive syncopes.

The examinations are carried out in cardiological patients who receive a tipping table examination with the aim of initiating a syncope. The question is whether there is hyperlactatemia following convulsive syncopes. If no elevated serum lactate values were measured after convulsive syncopes, this would additionally indicate the great benefit of the serum lactate value as a diagnostic marker in the generalized epileptic seizure.

In addition, a comparison is made with the parameters creatine kinase, prolactin, pH-value, bicarbonate, sodium and potassium.

If increased serum lactate values are measured following a syncope further venous blood controls are carried out at intervals of 20 minutes within the first hour and then after 90 minutes and 120 minutes until normalization.

Eligibility Criteria:
Inclusion Criteria:

* Patients with convulsive or non-convulsive syncopes
* 18 years or older

Exclusion Criteria:

* Prisoner
* Age \< 18 years old
* Lack of capacity for consent
Injectable Platelet Rich Fibrin With Demineralized Freeze-dried Bone Allograft in Treatment of Intraosseous Defects

Clinical and radiographic evaluation of injectable platelet rich fibrin (i-PRF) and demineralized freeze-dried bone allograft (DFDBA) compared to demineralized freeze-dried bone allograft (DFDBA) alone in management of intraosseous defects in stage III periodontitis patients.

Intraosseous defects are defined by the apical location of the periodontal pocket to the alveolar crest. In a recent radiographic study employing cone-beam computed tomography, a high prevalence of intraosseous defects 83% has been reported. Treatment of intraosseous defects is clinically challenging, as they often require complex regenerative periodontal therapy. Current regenerative techniques often employed in treatment of intraosseous defects demonstrate variation in improvement of clinical outcomes and degree of periodontal regeneration achieved.

Eligibility Criteria:
Inclusion Criteria:

1. Type III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intraosseous defect ≥ 3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level ≥ 5 mm and pocket depth ≥ 6 mm.
2. Defect not extending to a root furcation area
3. Vital teeth
4. Non-smokers.
5. No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
6. No periodontal therapy carried out in the past 6 months.
7. Able to sign an informed consent form.
8. Patients age between 25 and 50 years old.
9. Patients who are cooperative, motivated, and hygiene conscious.
10. Systemically free according to Cornell Medical Index

Exclusion Criteria:

1. Pregnancy or breast feeding
2. The presence of an orthodontic appliance
3. Teeth mobility greater than grade I
A Study for the Assessment of the Words Used by Patients and Physicians to Express Asthma Symptoms

The purpose of the study is to evaluate the concordance of the most frequently used words by the patients and the physicians to express asthma symptoms and the limitations of daily activities caused by asthma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of persistent asthma treated with inhaled corticosteroid-based maintenance treatment for at least 6 months and followed up by the investigator for at least the same period of time

Exclusion Criteria:

* Patient with a cardiac disease (congestive heart failure, coronary heart disease)
* Patient with a respiratory disease other than asthma (COPD, sleep apnoea syndrome)
Study of PEG-rIL-29 (or PEG-IFN Lambda) in Subjects With Chronic Hepatitis C Virus Infection

Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral infections. The purpose of this study is to test the safety and antiviral effects of PEG-rIL-29 (a man-made form of IL-29) when it is given either by itself at different doses or in combination with the approved dose of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease or who have relapsed following previous treatment with PEGylated interferon alpha (PEG-IFN-α), or other form of IFN-α, and ribavirin.

This is a 3-part study of PEG-rIL-29 in subjects with chronic genotype 1 hepatitis C virus infection who have either received no prior treatment with a PEGylated IFN-α (or other form of IFN-α) or who have relapsed following prior treatment with a PEGylated IFN-α (or other form of IFN-α) and ribavirin. Part 1 of the study will evaluate the safety and tolerability of escalating doses of PEG-rIL-29 when given as a single agent either every other week or weekly over a 4-week period to treatment-relapsed subjects. Part 2 of the study will evaluate dose levels and/or schedules of PEG-rIL-29 in combination with daily oral ribavirin administered over a 4-week period to treatment-relapsed subjects. Part 3 of the study will evaluate dose levels and/or schedules of PEG-rIL-29 in combination with daily oral ribavirin administered over a 4-week period to subjects who have received no prior treatment.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed subjects (Parts 1 and 2) -- Prior treatment for HCV with PEG-IFN-alpha (or other IFN-alpha) and ribavirin for at least 12 weeks. Naive subjects (Part 3) -- No prior treatment with PEG-IFN-alpha (or other IFN-alpha)
* Genotype 1 HCV RNA greater than or equal to 100,000 IU/mL. Mixed genotype HCV infection is not allowed
* Documented liver biopsy ≤2 years of study enrollment with Ishak score ≤4
* No evidence of hepatocellular carcinoma documented by abdominal imaging within 12 months of study entry
* no evidence of clinically significant diastolic or systolic dysfunction or other clinically significant abnormalities on echocardiogram or ECG
* Negative drug and alcohol tests except for physician prescribed or approved medication
* If male, or female of child-bearing potential, agrees to use 2 forms of medically accepted contraception while on study

Exclusion Criteria:

* Evidence of decompensated liver disease
* History of hypersensitivity to IFN-alpha or ribavirin
* Active substance abuse, such as alcohol, inhaled or injection drugs within the previous 6 months
* Undergone surgery or received blood products within 30 days prior to study enrollment
* Prior history of cardiomyopathy, coronary artery disease including angina, interventive procedure for coronary artery disease including angioplasty, stent procedure or cardiac bypass surgery, prior myocardial infarction, or ventricular tachycardia
* Prior or current history of hemoglobinopathy or hemolytic anemia
Synovial Fluid Sleep Study

This is an observational study of the relationship between perioperative sleep time/quality, synovial fluid cytokine profiles, and clinical outcomes of primary ACL reconstruction with BPTB autograft in 50 subjects. Sleep during the week before and month after surgery will be assessed using Fitbit smartwatch and sleep diary. Synovial fluid sampled preoperatively, intraoperatively, and postoperatively will be analyzed for levels of pro- and anti-inflammatory cytokines. Postoperative knee pain and function will be assessed until 2 years post-op using validated questionnaires.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Undergoing primary ACL reconstruction with BPTB autograft for acute ACL tear, with or without concomitant meniscectomy
3. Presenting within 2 weeks of injury and undergoing reconstruction within 8 weeks of injury

Exclusion Criteria:

1. History of blood-borne diseases including HIV, HBV, HCV, HTLV, or syphilis
2. Pregnant
3. Multiligamentous knee injury
4. Concomitant meniscal repair, meniscal allograft transplantation, osteotomy, or repair of focal chondral defect (e.g., osteochondral autograft transfer system, osteochondral allograft, matrix-induced autologous chondrocyte implantation)
5. Prior ipsilateral knee surgeries or injuries
6. Primary sleep disorders including insomnia, sleep apnea, or restless legs syndrome
7. Uncontrolled psychiatric disorders with sleep disturbance
8. Night shift work
9. Travel with time zone change within three weeks of surgery
10. Systemic inflammatory disease
11. Autoimmune disease
12. Immunomodulatory drug use
13. Chemotherapy within a year before surgery
14. Intra-articular injection within 3 months before surgery
Clinical and Economic Burden of Patients With Chronic Obstructive Pulmonary Disease in a Medicaid Population

Reports suggest that the Medicaid population includes a higher percentage of smokers than the general population. A high prevalence of smokers in a population is likely to lead to a higher burden of chronic obstructive pulmonary disease (COPD). Few studies have evaluated the economic burden of COPD in a Medicaid population. The objective of this observational, retrospective cohort study is to estimate the economic burden of COPD in subjects with a COPD diagnosis who are enrolled in Medicaid and are receiving maintenance treatment covered by Medicaid.

Specifically, the null hypothesis for the primary outcome measure is that no difference is observed in all-cause costs between subjects with and without COPD. The test hypothesis is that there is a difference in all-cause costs between subjects with and without COPD.

Secondary outcomes to be evaluated include all-cause resource use and COPD-related costs for the COPD cohort.

The study uses a medical and pharmacy administrative claims database called MarketScan Medicaid Database that contains the medical, surgical, and prescription drug experience of nearly 7 million Medicaid recipients. This analysis will use data from 8 states.


Eligibility Criteria:
Inclusion Criteria:

* at least 40 years of age at index date
* continuously eligible to receive healthcare services through Medicaid in the pre-index and follow-up period
* enrolled in fee-for-service plans
* without a diagnosis code of exclusionary comorbid conditions - cystic fibrosis, bronchiectasis, respiratory cancer, pulmonary fibrosis, pneumoconiosis, sarcoidosis, pulmonary tuberculosis (including fibrosis due to tuberculosis)

Exclusion Criteria:

* age less than 40 at index dates
Effects of Caffeine on Methacholine Challenge and Exhaled Nitric Oxide Levels.

To investigate whether or not the ingestion of caffeine with alter airway responsiveness to methacholine and/or change the level of exhaled nitric oxide.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of asthma
* FEV1 greater than 65%

Exclusion Criteria:

* asthma is poorly controlled
* presence of other airway disease (e.g. COPD)