cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease

The objective of the study was to evaluate the efficacy and safety of SND 919 (pramipexole) tablets administered in combination with L-dopa in patients with Parkinson's disease using placebo and bromocriptine tablets as comparators in a double-blind design (phase III comparative study).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)
* Patients who meet all of the following inclusion criteria

  * Patients who were at least 20 years of age
  * In- or outpatients of either sex
  * Patients in any stage on the modified Hoehn and Yahr scale
* Patients being treated with L-dopa who have any of the following clinical conditions and problems

  * Patients with the wearing-off phenomenon
  * Patients with the on-off phenomenon
  * Patients to whom a sufficient amount of L-dopa cannot be administered owing to the occurrence of an adverse event
  * Patients in whom the effect of L-dopa is attenuated
  * Patients in whom a dose increase of L-dopa has been refrained
  * Patients with freezing phenomenon

Exclusion Criteria:

* Patients being treated with other dopamine agonists (bromocriptine, pergolide mesylate, talipexole hydrochloride). Patients who have been treated with other dopamine agonist for at least 4 weeks before the start of the study (the day of giving informed consent) are eligible for the study
* Patients with a history of hypersensitivity to ergot preparations
* Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour
* Patients with subjective symptoms derived from orthostatic hypotension
* Patients with hypotension (systolic blood pressure less than 100 mmHg)
* Patients wiht Raynaud disease
* Patients with peptic ulcer
* Patients with complications such as severe cardiac, renal, hepatic disease etc.
* Patients with a current or past history of epilepsy
* Women who are or may be pregnant and lactating women
* Patients who are receiving any other investigational products or who have received any other investigational product within 6 months of the study
* Patients who are incompetent to give consent
* Others judged by the investigator or co-investigator to be ineligible as subjects
Amylin and CGRP Head to Head Provocation in Migraine Without Aura Patients

Amylin and calcitonin gene related peptide (CGRP) are related to the same peptide family. Both share 16 out of 37 amino acids and can activate each others receptor. CGRP is implicated in migraine pathophysiology but the role of Amylin and its receptor in migraine is not fully clarified.

Amylin is a peptide hormone that binds to a G-protein coupled receptor (GPCR). amylin was originally found in the pancreas (Beta Cell of Islets of Langerhans) but also shown to be present in the trigeminal ganglion, hind horn ganglia and perivascular nerve fibers.

Amylin has many similarities with CGRP. Amylin and CGRP share 16 out 37 amino acids. Both peptides can activate the amylin 1 subtype (AMY1)receptor with high affinity and reported to have more similar physiological and pharmacological effects.

In addition, both peptides increase the intracellular concentration of cyclic AMP (cAMP) which has a central role in migraine pathophysiology.

The aim of the study is pin point the role of amylin and amylin receptor compare to CGRP in migraine pathophysiology.

Eligibility Criteria:
Inclusion Criteria:

* Migraine patients meeting International Headache Society (IHS) criteria for migraine without aura of both sexes, 18-60 year, 50-100 kg.
* Fertile women should use safe contraception. Fertile women do not include hysterectomized women or women who are postmenopausal for at least 2 years. Safe contraception includes either Intra Uterine Device (IUD), birth control pills, surgical sterilization of the woman or depot progestogen.

Exclusion Criteria:

* Tension Type headache for more than 5 days the month on average in the last year.
* All other primary headaches .
* Headache later than 48 hours before trial start.
* Daily intake of any medicine other than oral contraception.
* Ingestion of any form of medicinal product later than 4 times the plasma half-life substance (on trial day), except for oral contraception.
* Pregnant or breastfeeding women.
* Headache on the test day or later than 48 hours prior to administration of trial medicine / placebo
* Migraine within 5 days before the trial date.
* Ancestral information or clinical signs of (on the day of inclusion):
* Hypertension (systolic blood pressure\> 150 mmHg and / or diastolic blood pressure\> 100 mmHg)
* Hypotension (systolic blood pressure \<90 mm Hg and / or diastolic blood pressure \<50 mmHg)
* Cardiovascular disease of all kinds, including cerebrovascular disease.
* Anamnestic or clinical signs of mental illness or abuse.
* Patients with glaucoma or prostatic hyperplasia
* Anamnestic or clinical signs of diseases of any kind such as the investigating physician is considered relevant for participation in the trial.
Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome

The primary aim of this trial is to investigate adipose tissue function in women with and without polycystic ovary syndrome (PCOS). PCOS is a common endocrine disorder in young women. The pathogenesis behind PCOS is complex and only partly understood, and deeper mechanistic insight is needed. Insulin resistance is a central feature of PCOS, and recent studies have suggested that this is linked to aberrant adipose tissue function. Exercise training has been found to improve the symptoms in PCOS, but we need more knowledge about why. While processes involved in skeletal muscle oxidative remodeling are well described, it is to a large extent unknown whether the oxidative capacity of human adipose tissue is modified by endurance training. The women included in this study will be matched (for body mass index, body weight, and age) to participants in another study. This will enable the investigators to do a comparison between cases (women with PCOS) and controls (women without PCOS) at baseline, and to assess the responses to exercise training in adipose tissue.


Eligibility Criteria:
Inclusion Criteria:

* eumenorrheic
* matching PCOC group in IMPROV-IT study (NCT02419482)
* Living nearby St Olavs Hospital, Trondheim, Norway

Exclusion Criteria:

* Signs of hyperandrogenism
* Regular high intensity endurance (two or more times per week of vigorous exercise).
* Concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion).
* On-going pregnancy
* Hormonal contraception
* Breastfeeding within 24 weeks
Pediatric PET/MR Image Registry

The purpose of this study is to compare whole body magnetic resonance (MR) imaging, whole body positron emission tomography (PET)/MR imaging, and (if available) PET/Computed Tomography (CT) imaging for the diagnosis of tumors in children and young adults. Sensitivities, specificities and diagnostic accuracies of the different imaging modalities will be compared for significant differences.


Eligibility Criteria:
Inclusion Criteria:

* Patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor.
* We might also include some patients with leukemia if there is concern for a focal lesion in any of their organs.
* Participant's parents (if participant is under 18) or the participant (if participant is 18 years or older) must willingly give written informed consent prior to any image transfer to the image registry.

Exclusion Criteria:

* Patient has contraindications for MRI or PET/MR. This includes patients with cardiac pacemakers or intracranial vascular clips as well as patients with a blood glucose level \> 200 mg/dl.
* Lack of parental permission (if participant is younger than 18) or lack of informed consent (if participant is at least 18 years of age).
* Patient has a CNS primary tumor.
* Pregnant women and fetuses
IPG Replacement Study (PREFERENCE-H)

This post-marketing evaluation has been designed to consistently investigate the subject's preference when switching from a Medtronic® constant voltage or constant current device to a St Jude Medical Infinity™ or St Jude Medical Brio™ constant current system. As electrodes will not be re-positioned, differences in subject's preference are to be explained by the difference in shape of the delivered pulse or waveform between the two systems.


Eligibility Criteria:
Inclusion Criteria:

* Subject (and caregiver, if applicable) signed the approved Informed Consent;
* Subject is ≥ 18 and ≤ 74 years of age;
* Subject is bilaterally treated with deep brain stimulation (DBS) in the subthalamic nucleus (STN) using a constant voltage device (i.e. Soletra™, Itrel™, Kinetra™, ActivaPC™ or ActivaRC™ IPG) and is responding satisfactory to CV stimulation in the Investigator's opinion;
* In the physician's opinion, the subject is a suitable candidate for an IPG replacement with different stimulation paradigm;
* Subject needs and/or requests an IPG replacement within 12 months after consent and the current IPG has at least 2.6 V output left (i.e. approx. 30% of full battery capacity) at the time of subject enrollment;
* PD symptom onset is no longer than 20 years;
* Subject has a Hoehn \& Yahr score \<IV (on stim);
* Subject with a normal cognitive function (MMSE ≥25);
* Subject is fluent speaker (as judged by the investigator) of the language spoken in the country where the investigational site is located.

Exclusion Criteria:

* IPG battery has less than 30% battery life at the time of consent;
* Need to replace or reposition the leads or extensions during the IPG replacement procedure;
* Subject had \>10 recurrent falls experienced in the 3 months prior to consent;
* Subject is unwilling to change to either a St Jude Medical Infinity™ or Brio™ DBS system for the IPG replacement;
* Subject is unable to attend the study visits.
Autoimmune Gastrointestinal Dysmotility: Symptoms, Pathogenesis and Treatment

Autoimmune gastrointestinal dysmotility syndromes are poorly understood, and often difficult to treat because the underlying pathogenesis is unclear. Refractory symptoms result in an impaired quality of life. The presence of positive serum autoantibodies to peripheral nervous system gangliosides and glycoproteins is suggestive of a possible mechanism. Immunomodulator treatments have shown benefit in case reports and case series but standardized data for treatment response is lacking. Therefore, our primary aims are to further characterize this syndrome in terms of symptoms, laboratory testing, pathology, and assess treatment response of immunomodulator therapy. Our research plan involves identifying this subset of patients with autoimmune gastrointestinal dysmotility and dysautonomia, and studying them as they are managed by their gastroenterologists.The study team will administer symptom-based questionnaires in a systematic manner to assess the clinical trajectory of this population and treatment response. The investigators will also analyze laboratory values (antibody titers, tilt testing, inflammatory markers) and study pathology specimens (enteric and skin biopsies) obtained from this cohort to gain a deeper understanding of the pathogenesis of their disease.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, Aged\>15
* Evidence of enteric dysmotility with documented abnormality on objective testing which may include high resolution esophageal manometry, gastric emptying scintigraphy, SmartPill Wireless Motility Capsule, Sitz marker studies, antroduodenal manometry or anorectal manometry.
* English proficiency and literacy sufficient to sign consent form and fill out questionnaires.
* Previous Mayo paraneoplastic panel testing.
* Referring gastroenterologist has recommended intravenous immunoglobulin (IVIg) therapy.

Exclusion Criteria:

* Non-autoimmune causes of enteric dysmotility (diabetes, adrenal insufficiency, Parkinson's, thyroid, electrolytes, drugs, malignancy).
* Pregnancy as documented in EPIC with serum or urine Human chorionic gonadotropin (hCG) testing

  * If participants believe that they are pregnant, they will need to notify a study physician who will order a serum or urine hCG test for pregnancy within EPIC and remove them from the study if the test results come back positive.
* Previous treatment with IVIg.
Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

This study will conduct 3 intervention trials with 44 different participants in each trial, with 22 participants will undergo in-laboratory overnight polysomnograms (PSGs) at one night of medication intervention, and the other 22 at taking placebo (contained starch) 1 h before sleep. Three medication regimens will be tested: (1) atomoxetine 80mg combined with oxybutynin 5mg; (2) venlafaxine 37.5mg; and (3) atomoxetine 80mg combined with trazodone 100mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters.


Eligibility Criteria:
Inclusion Criteria:

* apnea-hypopnea index ≥ 15 hr-¹

Exclusion Criteria:

* the presence of pulmonary, cardiac, neurologic, or other active severe medical or psychiatric diseases
* current use of continuous positive airway pressure therapy
* use of drugs that might interact with the investigational medication or known to affect sleep during the trial or 1 month before the study
* known allergy to the investigational medication
* current smoking
* heavy alcohol drinking (male \> 14 drinks and women \>7 drinks per week)
* pregnant or lactating
* periodic limb movement index ≤ 15hr-1
* the presence of sleep-related hypoventilation
Evaluating the Efficacy of Dry Eye (DE) Disease Treatment Using Novel Tear Film Imager (TFI)

Dry Eye disease signs and symptoms are reduced in patients who receive topical steroids and topical hyaluronic acid.

AdOM's Tear Film Imager measurements are reproducible and it can diagnose the dry eye disease state in a single, non-invasive measurement. The Tear Film Imager can provide objective accurate measurements of the dry eye treatment effectiveness.

80 subjects will be enrolled , 40 of which with positive signs and symptoms of Dry eye and 40 healthy subjects without sign and no symptoms of Dry eye. Healthy and Dry eye groups will be age- matched.

Over a period of 4 weeks, the subjects diagnosed with dry eye will be treated and as follows:

1. Hylo-comod artificial tears (0.1 % sodium hyaluronate) 8 times a day for 4 weeks
2. Coll STERODEX (Dexamethasone sodium phosphate 0.1% eye drops) 3 times a day for 2 weeks Healthy subjects will not receive any treatment.

Both groups will be examined at baseline and 4 weeks after baseline measurement.

Treatment results will be measured by both traditional methods and by Tear Film Imager.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form.
2. Be at least 18 years of age at the time of enrollment of either sex or any race.
3. Best corrected visual acuity (BCVA) of 0.7 logMAR (ie, 20/100 vision) or better in each eye as measured using a Snellen chart
4. Intraocular pressure (IOP) in the range of 5 to 22 mmHg in both eyes.
5. DE subjects will be enrolled if they manifest symptoms (OSDI \>=13) and signs of clinically active dry eye disease in either eye, by at least one of:

   1. Corneal fluorescein staining - at least severe in one section or moderate at two
   2. TBUT =\< 10 sec
   3. Schirmer wetting of less than 10 mm in 5 min (with anesthesia).
6. Control will be enrolled if they manifest NO symptoms (OSDI \<13) and NO signs of clinically active dry eye disease in either eye, by meeting all the following criteria's:

   1. Corneal fluorescein staining - negative
   2. TBUT \> 10
   3. Schirmer wetting of more than 10 mm in 5 min (with anesthesia).
7. A negative urine pregnancy test if female of childbearing potential.

Exclusion Criteria:

1. Any ocular condition that could affect study parameters (glaucoma, nystagmus, keratoconus, follicular conjunctivitis, iritis or post LASIK, LASEK or PRK).
2. Have had any ocular infection within the last 30 days and/or have preauricular lymphadenopathy.
3. Any significant illness that could be expected to interfere with study parameters.
4. Use of any investigational product or device within one month prior to Visit 1 or during the study period.
5. Concomitant use of any prohibited medication (antihistamines, corticosteroids, all ocular medications or anti-allergic therapies) during the trial.
6. Any history of, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti HAV IgM), Any known history of iritis/uveitis, glaucoma, or other chronic ophthalmologic disorder other than allergic conjunctivitis.
7. History of any ocular surgical procedure within 3 months prior to Visit 1.
Vitamin D Supplementation in Children

Prevalence of vitamin D deficiency in children in the northern country during winter season is very high (up to 90%). Vitamin D supplementation at a dose 600 -1000 IU/d is recommended in Polish children from September till April. However, there is shortage of studies in Polish children. The aim of the study is to assess the effectiveness of vitamin D supplementation in the prevention of vitamin D deficiency in Polish children (4-10 years of age).

Prevalence of vitamin D deficiency in children in the northern country during winter season is very high (up to 90%). Vitamin D supplementation at a dose 600 -1000 IU/d is recommended in Polish children from September till April. However, there is shortage of studies in Polish children.

Aims:

1. Assessment of the impact of vitamin D intake at a dose of 1000 IU / day on vitamin D status in children aged 4-10 years.
2. Evaluation of the effectiveness of supply of vitamin D at a dose of 1000 IU / day in preventing vitamin D deficiency and maintaining optimal vitamin D status ( 25OHD level \>30ng/ml)
3. Evaluation of vitamin D status depending on age, BMI and body composition.
4. Assessing the safety and tolerability of mel ● tiki vitamin D in children. Material: Children aged 4-10 years Study desing: Prospective intervention trial Intervention: cholecalciferol at a dose 1000 IU/day for 3 months

Methods:

1. Analysis of clinical characteristics (attendance at kindergarten / school, consumption of products rich in vitamin D, exposure to sun, use of sunblock's, the overall child's health (chronic diseases, medications, vitamins, micronutrients)
2. Anthropometric measurements (body weight, height, BMI, assessment of body fat content - body composition by bioimpedance method- TANITA)
3. Assessment of vitamin D status (serum total 25OHD concentration in blood serum by immunochemiluminescence method)
4. Collecting data on the tolerability and safety of meliki ● tiki vitamin D including possible symptoms of vitamin D overdose

Eligibility Criteria:
Inclusion Criteria:

* Age 4-10 years; declaration of no use other preparations containing vitamin D; parental written informed consent

Exclusion Criteria:

* Osteoporosis, autoimmunological disorders, sarcoidosis, exacerbation of asthma, hypercalcemia, nephrolithiasis, renal insufficiency, nephrotic syndrome, cholestasis, hepatitis, diabetes typ 1, anticonvulsant treatment, prolonged treatment with steroids, cimetidine, ketoconazole, teophiline, diuretics, anti-tuberculosis drugs, participation in another clinical trial
Ultrasound After Total Shoulder Arthroplasty

The purpose of this study would be to evaluate a group of patients status post post-total shoulder arthroplasty to assess the integrity of the rotator cuff using ultrasound. We believe ultrasonography imaging to be a comparable and efficacious modality to evalute tenotomy healing rates and diagnose rotator cuff failure after total shoulder arthroplasty. In addition, we believe ultrasonography to be a cost-effective modality to asses the rotator cuff after total shoulder arthroplasty. Our population would consist of patients that received total shoulder arthroplasty within the last 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Primary or revision total shoulder arthroplasty with or without subscapularis tenotomy
* Primary or revision reverse shoulder arthroplasty with or without subscapularis tenotomy
* English speaking patients only
* Shoulder arthroplasty within the last 5 years

Exclusion Criteria:

* Revision shoulder arthroplasty for infection
* Pregnancy
Olive Polyphenols in Cardiovascular Prevention

The aim of this study is to evaluate whether the use of a commercially available standardized olive extract (Tensiofytol®) in individuals with elevated blood pressure

1. Leads to a clinically relevant reduction of blood pressure on the short term,
2. Leads to a clinically relevant reduction of cholesterol levels, especially LDL,
3. Leads to a change in oxidative stress biomarkers.

Participants will be stratified by sex before randomization to one of the three treatments for 8 weeks:

* Tensiofytol: 100 mg oleuropein and 20 mg hydroxytyrosol per day
* Placebo

All treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, nor to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured.


Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure ≥ 130 mmHg

Exclusion Criteria:

* \<18 jaar
* \>76 jaar
* Smoking
* Use of nutritional supplements or (chronic) medication\*
* Triglycerides \> 400 mg/dL
* \> 14 alcoholic consumptions/week
* Chronic illness (e.g. diabetes, atherosclerosis, reumatoid arthritis)
* Acute infection
* Current pregnancy or pregnancy wish during the study period
* Breast feeding

  * When nutritional supplements were used regularly, participation is allowed after a 10-day wash out period.

Use of medication will be individually assessed and is permitted if it does not interfere with the used treatments and the patient is stable on the medication.