cyrilzakka/clinical-trials huggingface dataset:
Rehabilitation After Radiotherapy for Prostate Cancer

This project will test and evaluate a rehabilitation programme, which will empower the mens health and give them resources to face at new everyday life.

The project examines if a focused interdisciplinary intervention has influence of the patients generic and specified quality of life after curative radiotherapy due to prostate cancer.

The intervention contains nursing consultation with information about late side effects, an individual plan and counselling in toilet habits, smoking cessation, weight control and psychological problems after treatment. Furthermore the patients are having physiotherapy with pelvic floor examinations. The nurse can refer to other collaborators.

More cancer patients are now being cured or living a long time with the disease. Prostate cancer (PCa) is one of the cancer diseases, where the treatment can give some late side effects and cause reduced life quality.

This project will as a part of a ph.d. study, test and evaluate a rehabilitation programme, which will empower the mens health and give them resources to face at new everyday life.

The project is consisted of a randomised controlled test of the intervention and qualitative evaluation.

More and more Danish men are diagnosed with PC, the incidence increased with 34 percent from 2005-2007. This is caused partly due to a change in the age in the society and due to earlier diagnostics. PCa is now the most known cancer occurring in men in Denmark.

If the disease has not yet been metastasized, it is possible to use radiotherapy often in combination with anti hormones. It is possible to cure the patient, íf his disease is discovered in time, but there are some late side effects bond to the treatment, and they have influence of the patients quality of life. These are: impotence, incontinence, problem with the bowels, anxiety and depression.

The project is as followed:

Rehabilitation: Examine if a focused interdisciplinary intervention has influence of the patients generic and specified quality of life after curative radiotherapy due to prostate cancer. The intervention contains nursing consultation with information about late side effects, an individual plan and counselling in toilet habits, smoking cessation, weight control and psychological problems after treatment. Furthermore the patients are having physiotherapy with pelvic floor examinations. The nurse can refer to other collaborators.

Methods: Prospective randomised controlled study. Material: 160 patients are included. 80 patients in the intervention group and 80 patients in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with localized og locally advanced prostate cancer treated with curative intended radiotherapy at Department of Oncology Odense University Hospital in the period of inclusion

Exclusion Criteria:

* Patients younger than 18
* Patients who cannot understand/read or speak danish
Implication of CD35, CD21 and CD55 in Exudative Age-related Macular Degeneration

The purpose of this study is to determine a possible implication of CD21, CD35 and CD55 in the pathogenesis of age-related macular degeneration. The aim is to asses a difference in expression rates of these factors on AMD-patients and a healthy control group.


Eligibility Criteria:
Inclusion Criteria:

* Man and women over 18 years old
* Filled out informed consent
* Diagnosis of non-exudative/ exudative age related macular degeneneration

Exclusion Criteria:

* Inherited retinal diseases
* Other acquired retinal/ macular
* Missing informed consent
Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers

To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran etexilate as capsule following oral administration. To evaluate acceptability and palatability of Pellets sprinkled on food and Oral Liquid Formulation


Eligibility Criteria:
Inclusion criteria:

1. Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory tests
2. Age 18 to 55 years (incl.)
3. Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

1. Any finding in the medical examination (including Blood Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator.
2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
8. Subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of:

   * Hemorrhagic disorders or bleeding diathesis
   * Occult blood in faeces or haematuria
   * Trauma or surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned surgery during trial participation
   * History of arteriovenous malformation or aneurysm
   * History of gastroduodenal ulcer disease or gastrointestinal haemorrhage
   * History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding
   * Anemia at screening
   * Thrombocytopenia (platelet count less than 100/nL)
PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK

The aim of this study is to investigate how the efficacy and tolerability of PD P 506 A-PDT relate to the commonly used cryosurgery in the treatment of mild to moderate AK lesions located on the head. To be able to quantify the effect the patient will be allocated to one of three treatments: PD P 506 A-PDT, cryosurgery or placebo-PDT.

Actinic keratosis (AK) is a pre-cancerous skin abnormality usually caused by sun exposure. Actinic keratoses occur most commonly in fair skin, especially in the elderly. They mainly occur in sun-exposed skin areas like head and hands. It is standard of care to remove AK when diagnosed, which can be achieved by either physical ablation, chemotherapeutic agents or photodynamic therapy (PDT). In Europe, cryosurgery is the method primarily used and will therefore serve as comparator therapy for PD P 506 A-PDT. A placebo control will be necessary to validate the test system. While the comparison of PD P 506 A-PDT and cryosurgery is an open comparison, placebo-PDT and PD P 506 A-PDT will be allocated in a double-blind manner.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Caucasians
* Age \> 18 years
* Diagnosis of actinic keratosis (AK) with at least four locally separated lesions located on head and/or face (hairless areas)
* Selected AK study lesions have clearly defined margins and are mild to moderate (grades I or II)
* The distance between the study lesion borders is \> 1.0 cm
* Maximum diameter of each study lesion is 1.8 cm
* Skin sun sensitivity type I to IV according to Fitzpatrick

Exclusion Criteria:

* PDT Non-responder
* Pre-treatment of the AK lesions eligible for study procedures with pharmaceuticals approved for the treatment of AK during the 4 weeks preceding study treatment
* Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding study treatment with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
* Pre-treatment with hypericin during the 2 weeks preceding study therapy
* Treatment with systemic retinoids during the 3 months preceding study therapy
* Treatment with cytostatics or radiation during the 3 months preceding study therapy
* Female patients of childbearing potential
* Patients with clinically relevant suppression of the immune system
* Diagnosis of Porphyria
* Skin diseases that might interfere with response evaluation of study treatment
* Skin sun sensitivity type V or VI according to Fitzpatrick
* Known intolerance to one or more of the ingredients of the study medication
* Known adverse reactions to cryosurgery (including cold urticaria and cold intolerance)
* Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
* Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion
* Suspected lack of compliance
A Study of the RevLite Laser System for the Treatment of Refractory Mixed Type Melasma

The purpose of this study is to compare a hydroquinone skin care regimen alone to a combination of Revlite Laser treatment with a hydroquinone skin care regimen for the treatment of melasma.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Fitzpatrick Skin Type III-VI
* Subjects with mixed (epidermal and dermal) type melasma diagnosed by Wood's Lamp.
* Subjects who are over the age of 18 years of age
* The subject is willing and able to comply with study instructions and return to the clinic for required visits.
* The subject's melasma has persisted for greater than 6 months

Exclusion Criteria:

* The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
* The subject has a history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis.
* The subject has any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy.
* The subject has an uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy).
* The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
* The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days prior to entering this study.
* The subject has used photosensitizing drugs (e.g., Declomycin, sulfa antibiotics, phenothiazines, etc.) within a timeframe where photosensitization from these drugs may still be present.
* The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
* The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
* The subject has Diabetes Type 1 or 2.
* The subject has a sensitivity to hydroquinone or Retin-A.
* The subject has evidence of a compromised immune system or hepatitis.
* Has had microdermabrasion in past 3 months, other laser or Intense Pulsed Light treatment or chemical peels to the face in past 6 months, injectable fillers, topical retinoids, over-the-counter anti-aging products past 2 weeks.
* Has a history of keloids or hypertrophic scarring
* Has permanent make-up and/or is unwilling to refrain from using semi-permanent cosmetics during study
Spinal Mobilization Versus Myofacial Release Techniques On Pain And Disability In Patients With Tension Type Headache

The most frequent kind of primary headache is tension headache, often known as stress headache or tension-type headache (TTH). The pain usually affects both sides of the head and might extend from the lower back of the head, the neck, the eyes, or other muscle groups in the body. Nearly 90 percent of all headaches are tension-type headaches causing a debilitating effect on job productibility and overall quality of life. The aim of the study will be to compare the effects of spinal mobilizations comprising Mulligan's headache SNAGs and Maitland's PA glide with the myofascial release technique on pain and disability in patients with tension-type headache.

A Randomized Clinical Trial will be conducted at FMH Physiotherapy Clinic, NUR International Physical Therapy clinic and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on 34 patients which will be allocated using simple random sampling through sealed opaque envelopes into Group A and Group B. Group A will be treated with Spinal Mobilizations comprising Mulligan's headache SNAGs and Maitland's PA glide and Group B will be treated with Myofascial release technique. Outcome measures tools will be conducted through NPRS, Headache disability Index, Headache impact test (HIT-6). Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups

Eligibility Criteria:
Inclusion Criteria:

* • Male and female between ages of 30-60 years

  * Presence of 2 or more of the following: bilateral headache, pressure or squeezing pain, mild or intermediate pain intensity, and headache not elicited by daily physical activities
  * Headache lasting between 30 minutes and 7 days
  * Patients with no increase in pain during physical activity
  * Patients not having any photophobia, phonophobia during headache
  * Headache unaccompanied by vomiting or nausea

Exclusion Criteria:

* Any other primary or secondary headache according to the ICHD-III criteria.

  * A history of neck or head trauma (e.g., whiplash).
  * Any red flags (vertebral tumor, fracture, dislocation and infection, metabolic diseases, rheumatic and connective tissue diseases, systemic neuromuscular diseases, prolonged history of steroid use).
  * Diagnosis of any structural spinal disorders (osteoporosis, disc herniation, myelopathy, spinal stenosis, spondylolisthesis).
  * Prior surgery to the cervical spine.
Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients

With the perception that lung protective ventilation with regard to low tidal volume ventilation and limiting airway pressures improves outcome in ARDS (acute respiratory distress syndrome) and that the development of new technical devices of extracorporeal lung assist systems with lower complication rates support establishment of lung protective ventilation strategies these systems are more and more frequently used. All critically ill patients with and without ECLA (extracorporeal lung assist)/ECMO (extracorporeal membrane oxygenation) treatment are on high risk for muscle wasting, leading to more comorbidity and higher mortality risk. Besides inflammation malnutrition is known as one of the main risk factors. Over and underfeeding should be prevented. However nutritional aspects of patients on extracorporeal lung assist are hardly investigated. Up to now changes in metabolic rates induced by ECLA/ECMO are poorly described. Factors like work of breathing, changes in cardiac output and septic state are influencing energy metabolism but until now there is no tool for measuring energy expenditure in clinical routine for patients on ECLA/ECMO. Indirect calorimetry is a simple device only for patients without ECLA/ECMO system. Oxygenation and CO2 (carbon dioxide) elimination by the lung assist system can be calculated but is not implemented to clinical routine. The combination of indirect calorimetry and calculation of lung assist function at the same time would give us the chance to adapt nutrition rates to energy expenditure. This may prevent muscle wasting and weakness. This pilot study will include 40 participating patients during 8 month investigating nutritional therapy adapted to energy expenditure calculated by O2 and CO2 turnover rates in patients on ECLA or ECMO systems. The investigators aim is to describe a calculation to set nutrition targets in ECMO patients. Second the investigators will describe level of nutritional needs under consideration of different mechanical ventilation states. Third O2 consumption and CO2 elimination will be used to estimate cardiac output.


Eligibility Criteria:
Inclusion Criteria:

* critically ill patients with ALI
* informed consent by the patients or legal proxy

Exclusion Criteria:

* age \< 18
* no informed consent by the patients or legal proxy
* pregnancy
* infaust prognosis
Correction of Farsightedness in Children Study

The Correction of Hyperopia In Children Study (CHICS) is a placebo-controlled, randomized, masked investigation of the effect of spectacle correction for moderate amounts of hyperopia on visual function, attention, and reading skills in children.

Hyperopia (farsightedness) has been reported to be associated with reduced visual perceptual and reading abilities. However, there is controversy regarding whether or not to prescribe for low to moderate amounts of hyperopia. The Correction of Hyperopia In Children Study (CHICS) is a placebo-controlled, randomized, masked investigation of the effect of spectacle correction for moderate amounts of hyperopia on visual function, attention, and reading skills in children.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-11 years;
* At least +1.00D Hyperopia (farsightedness);
* \< +4.00D Hyperopia;
* \< 1.00D Astigmatism;
* \< 1.00D Anisometropia (difference between the two eyes);
* Willing to be randomized;
* Best corrected visual acuity of 20/25 or better in each eye;
* Willing to wear eyeglasses full-time;
* Willing to return for follow-up visits

Exclusion Criteria:

* Previous wear of glasses or contacts for farsightedness/hyperopia;
* Eye disease that affects visual function;
* Amblyopia (lazy eye);
* Strabismus (eye turn);
* History of strabismus surgery;
* Chronic use of any of the following medications:

  * Antianxiety agents (Librium, Valium)
  * Antiarrythmic agents (Cifenline, Cibenzoline)
  * Anticholinergics (Motion sickness patch - scopolamine)
  * Bladder spasmolytic (Propiverine)
  * Chloroquine
  * Phenothiazines (Compazine, Mellaril, Thorazine)
  * Tricyclic antidepressants (Elavil, Nortriptyline, Tofranil)
An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection

Subjects will be stratified by weight to receive one of two doses of study drug

Eligibility Criteria:
Inclusion Criteria:

* Informed consent and HIPAA authorization of the infant's parent or legally authorized representative must be obtained prior to study entry
* Infant has sufficient venous access to permit study drug dosing
* Infant is suspected to have a systemic Candida infection and appropriate cultures (blood with or without urine/CSF) are obtained at the time of study entry

Exclusion Criteria:

* Infant has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
* Infant has received an echinocandin within one month prior to study entry
* Infant has a concomitant medical condition which, in the opinion of the investigator and/or medical advisor, may create an unacceptable additional risk
* Infant has a life expectancy of less than 96 hours
Magnesium in Liver Cirrhosis

Several studies have shown in patients magnesium deficiency with liver cirrhosis.

Patients with liver cirrhosis showed considerably reduced muscle strength and muscle magnesium.

We suggest addition of magnesium to patients with established cirrhosis in order to reduce the neuromuscular and neuropsychiatric manifestations of chronic liver disease.

Magnesium is the fourth most abundant cation in the body and plays an important physiological role in many of its functions.

There are no readily available and easy methods to assess magnesium status but it is estimated that magnesium deficiency is a common problem.

Magnesium deficiency can cause a wide variety of features including hypocalcaemia, hypokalaemia and cardiac and neurological manifestations. Chronic low magnesium state has been associated with a number of chronic diseases including diabetes, hypertension, coronary heart disease, and osteoporosis.

There are not enough studies on magnesium status in chronic cirrhotics who may be in depletion. However , several studies have shown in patients magnesium deficiency with liver cirrhosis. Patients with liver cirrhosis showed considerably reduced muscle strength and muscle Mg . Magnesium may have a role in the neuromuscular and neuropsychiatric manifestations of chronic liver disease (hepatic encephalopathy and muscle cramps).

The use of magnesium as a therapeutic agent in asthma, myocardial infarction, and pre-eclampsia is also discussed. We suggest addition of magnesium to patients with established cirrhosis in order to reduce the neuromuscular and neuropsychiatric manifestations of chronic liver disease.

Eligibility Criteria:
Inclusion Criteria:

* patients with liver cirrhosis

Exclusion Criteria:

* pregnant women
* Patients with acute or chronic renal failure (cr\>1.5)
* Congestive heart failure NYHA 3-4
* Patient with active cancer
* Patients with dementia or mental retardation
Safety Study of Thumb Orthoses in Osteoarthritis in the Base of the Thumb (BTOA)

The prevalence of digital osteoarthritis varies according to whether a radiological or clinical definition is adopted.

Interventions: Thumb orthoses to be worn at night and usual care vs usual care. Outcome measures: Pain at 1 month assessed on visual analog scale is the main outcome measure. Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main secondary outcome measures.

The prevalence of digital osteoarthritis varies according to whether a radiological or clinical definition is adopted. Radiologically defined osteoarthritis of the hand has been estimated to represent 38% of women and 24.5% of men over 66 years of age but higher prevalence of 60-70% has also been reported. Of patients with radiological signs, 20 to 40% become symptomatic. For patients over 55 years of age, the distal interphalangeal joints are the most prevalent site of osteoarthritis (20%) determined radiologically and clinically, followed by the base of the thumb (8%) and proximal interphalangeal joints (5%). This prevalence increases with age, and the incidence peaks in perimenopausal women. Osteoarthritis in the base of the thumb (BTOA) concerns the trapeziometacarpal joint, with a possible secondary location at the trapezotrapezoidial and scaphotrapezial joints. BTOA induces a closure of the first web, which in turn causes an alteration of the thumb-index pinch and therefore a limitation in hand function. Pain induced by the compression of the thumb column during pinching could also lead to functional disability. Effect of a simple intervention such as wearing rest thumb orthoses on pain and disability is unknown.

Eligibility Criteria:
Inclusion Criteria:

* Pain at the base of the thumb 30 mm on VAS
* Patient aged 45 and \< 75 years old
* At least 2 of the 5 items on the trapeziometacarpal joint radiograph osteophytes
* joint space narrowing
* subchondral bone sclerosis
* subchondral cysts
* At least 1 of the 2 clinical items trapeziometacarpal joint enlargement closure of the first web

Exclusion Criteria:

* Post traumatic osteoarthritis
* Cristal arthropathy
* Inflammatory arthritis
* Neurologic disorder involving upper limb
* Psychiatric disorder needing treatment adaptation in the last 3 months
* Hand or wrist trauma within the last 2 months
* Previous hand surgery
* Unable to speak or write French
* Pregnancy
* Collagen diseases (Dupuytren, Marfan, Ehlers Danlos syndromes)
* Hand or wrist infiltration within 2 months
* Skin disease interfering with the wearing of the orthoses
* Having already worn a BTOA orthoses
* Having bilateral BTOA without predominant symptomatic side