cyrilzakka/clinical-trials huggingface dataset:
Tolerability of Quinagolide in a Dose-titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome

Assess the tolerability of quinagolide 200 μg/day in a dose-titration regimen in oocyte donors undergoing controlled ovarian hyperstimulation and at risk of developing OHSS Secondary Objectives

Estimate the effects of a quinagolide dose-titration regimen compared to placebo in peritoneal fluid accumulation, incidence of ascites, OHSS symptoms and clinical laboratory parameters of haemoconcentration


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form, prior to screening evaluations
2. In good physical and mental health
3. Pre-menopausal females between the ages of 21-34 years (both inclusive) at the time of randomisation
4. Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive)
5. Oocyte donor currently undergoing a controlled ovarian hyperstimulation cycle for assisted reproductive technologies (ART)
6. Antral follicle count ≥ 20

Exclusion Criteria:

1. Any exclusion criteria for oocyte donation
2. Known clinically significant systemic disease (e.g., insulin dependent diabetes)
3. Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study
4. Undiagnosed vaginal bleeding
5. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
6. Malformations of the sexual organs incompatible with pregnancy
7. Positive pregnancy test prior to start of stimulation
8. Treatment with other dopamine agonists (ATC code N04BC) or dopamine antagonists (ATC code N05A) within 2 months prior to randomisation
9. Treatment with any hormonal therapy (except for thyroid medication and oral contraceptives and except that routinely used as part of the controlled ovarian hyperstimulation cycle), anti-psychotics (ATC code N05A), anti-depressants (ATC code N06), anxiolytics (ATC code N05B), hypnotics and sedatives (ATC code N05C) or continuous use of prostaglandin inhibitors (non-steroid anti-inflammatory drugs (NSAIDs), including aspirin) within 2 weeks prior to randomisation
10. Known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
11. Known history of psychotic disorders
12. Hypotension, orthostatic hypotension or recurrent syncope within 6 months prior to randomisation
13. Ongoing treatment of hypertension
14. Known previous poor tolerability to dopamine agonists
15. Known impaired hepatic or renal function
16. Current or past (12 months prior to randomisation) abuse of alcohol or drugs, and/or current (last month prior to randomisation) use of alcohol (more than 14 units per week)
17. Current or past (3 months prior to randomisation) smoking habit of more than 20 cigarettes per day
18. History of chemotherapy (except for gestational conditions) or radiotherapy
19. Use of any investigational drug during 3 months prior to randomisation
20. Previous participation in the study
21. Hypersensitivity to the active substance or to any of the excipients
Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis

This study is a randomized controlled study in which we aim to include 60 persons with Multiple Sclerosis and 30 healthy controls. Two different learning strategies, an explicit and an implicit one, will be compared on effects on dual task performance. Further, clinical profile associated with these effects, and brain activity measured by functional near-infrared spectroscopy during dual tasking will be investigated.

To this end, the study will cover 4 days:

Day 1: examine clinical profile; Day 2: baseline dual task measures; Day 3: experimental learning paradigm with subjects randomly assigned to either the implicit or the explicit learning condition.

Day 4: delayed retention dual task and fNIRS measures.


Eligibility Criteria:
Inclusion Criteria:

* all participants: minimal cognitive function (MoCA ≥ 26)
* Persons with MS:

  * Diagnosis of MS
  * EDSS 2.0 - 5.5
  * No relapse within the past 30 days.
  * Able to walk minimally 6 minutes consecutively and to step over the stepping platform without aid.

Exclusion Criteria:

* Other medical conditions interfering with mobility.
* Other neurological conditions.
* Not able to understand instructions.
* Major (unresolvable) problems with hearing or vision.
High-Intensity Exercise and Endothelial Function in Type 1 Diabetes(HIIT-T1D)

To study the effect of 8 week high-intensity interval training (HIIT) compared with moderate intensity (MCT) interval training and sedentary patients(CON) with type 1 diabetes. Adult T1DM patients without known complications are randomised in blocks into these 3 groups according to their baseline flow mediated dilation (FMD). After 8 week exercise training, the main outcome, FMD, is re-evaluated. Additional variables such as VO2 peak for cardiovascular fitness, oxidative stress and endothelial independent vasodilation to study vascular rigidity are also evaluated.

In a randomized controlled open trial, 36 adult type 1 diabetes mellitus (T1DM) patients without known complications were randomized into 3 groups: HIIT n=12; MCT n=12 and a sedentary control group (CON) n=12. Total sample size was calculated to a power of 80% alha 0.05 and a difference in mean FMD of 2%. Before randomisation, flow mediated dilation (FMD) and maximal exercise capacity (VO2 peak)is determined. Block Randomisation based on FMD rank values are done to equalize baseline FMD. Exercise sessions are performed in cycle ergometers during 40 minutes, 3 times a week, along 8 weeks. HIIT protocol, intensity vary from 50 to 85% of the maximum heart rate (HRmax), while in MCT, HR remained stable at 50% HRmax. Endothelial function was measured by flow mediated dilation (FMD) for endothelium-dependent vasodilation (EDVD) and smooth-muscle function was measured by nitroglycerine mediated dilation (endothelium independent vascular dilation) - (EIVD). Peak oxygen consumption (VO2peak) and oxidative stress markers were determined before and after the training period. ED was defined as an increase of less than 8% in vascular diameter after cuff release.

Eligibility Criteria:
Inclusion Criteria:

T1DM

* Physically inactive or not involved in exercise training programs in the previous 6 months
* Interested in starting an exercise training program.

Exclusion Criteria:

* Smokers,
* Pregnancy
* Co-morbidities not related to diabetes
* Drugs other than insulin
* Loss of renal function (serum creatinine above 1.5 mg/dl),
* Moderate to severe retinopathy or blindness,
* Suspected or confirmed coronary artery disease,
* Severe peripheral neuropathy
* Foot ulcers or history of previous foot ulcer
* Suspected or confirmed clinical autonomic neuropathy.
Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study

This study evaluates the effectiveness of re-treatment using accelerated schedule of intermittent theta-burst stimulation for treatment-resistant depression. This is an open label study.

Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study will investigate the efficacy of a further modified protocol, creating a more rapid form of the treatment and look at the change in neuroimaging biomarkers. In particular, this study will determine the efficacy of re-treatment in individuals who have already experienced benefit of the accelerated protocol to ensure results can be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 75 years of age.
* Able to provide informed consent.
* Diagnosed with Major Depressive Disorder (MDD) or bipolar affective disorder 2 and currently experiencing a Major Depressive Episode (MDE).
* prior exposure to rTMS
* Participants must qualify as "moderate or severe treatment refractory" using the Maudsley staging method.
* Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. They must maintain that same antidepressant regimen throughout the study duration.
* Participants are required to have a stable psychiatrist for the duration of study enrollment.

Exclusion Criteria:

* History of MI, CABG, CHF, or other cardiac history
* Any neurological conditions
* History of epilepsy
* OCD
* Independent sleep disorder
* Autism Spectrum Disorder
The Radiation ProtEction for Dose RedUction in the Cardiac CathEter Lab Study: the REDUCE Trial

Doctors and nurses who perform heart procedures using X-ray guidance are exposed to radiation, which can be harmful over time. This exposure increases the risk of certain health problems, including cancers, eye damage (cataracts), and DNA damage. Although protective lead clothing is used to reduce exposure, it is heavy, uncomfortable, and can cause muscle and joint problems for those who wear it daily.

A new radiation protection device, called RAMPART, may help reduce radiation exposure for heart specialists and their teams. It could also allow them to wear lighter protective gear-or none at all-making their work safer and more comfortable.

This study will compare the radiation levels received by doctors and nurses during heart procedures when using RAMPART versus standard protection. By doing so, we hope to find out if this new device can better protect medical teams from radiation, improving both their safety and well-being.

Recent decades have seen major increases in x-ray guided procedures in interventional cardiology, radiology and vascular surgery. Exposure to ionising radiation is known to be an inherent risk and remains a serious and unresolved threat to the health of operators and their team. It is associated with an increased incidence of brain and blood cancers, cataracts, and recent mechanistic data indicates significantly increased DNA damage in those without leaded leg protection.

Although existing standard radiation protection measures somewhat reduces exposure, all cardiac catheter lab personnel still receive a certain dose of radiation and continue to accumulate lifetime exposure. Furthermore, leaded personal protective equipment is heavy, leads to orthopaedic complications, and detracts from operator comfort.

Novel radiation protection devices such as RAMPART may significantly reduce radiation doses to cardiac catheter lab personnel, and potentially allow the use of lighter lead, or no lead at all. In this study we aim to investigate if use of RAMPART significantly reduces radiation exposure, when compared with standard radiation protection. Standard coronary intervention procedures will be randomised to RAMPART or standard (radiation protection), and operators and Cath lab team doses will be compared.

Eligibility Criteria:
Inclusion Criteria:

* All procedures involving adult patients (\>18 year of age)
* Male or female patients
* Planned to undergo either an elective or urgent coronary intervention procedure involving ionising radiation in the cardiac catheter lab, via the right and or left radial arteries.

Exclusion Criteria:

* Procedures involving patients less than 18 years of age
* Patients unable to give valid consent
* Pregnancy
* Femoral approach procedure
Manipulation or Microdiscectomy For Sciatica? A Prospective Randomized Controlled Trial.

The purpose of this study was to compare standardized chiropractic treatment (spinal manipulation) to back surgery (microdiscectomy) for patients with sciatica secondary to lumbar herniated disc refractory to medical management.

Context: Operative management of lumbar radiculopathy caused by lumbar disc herniation (LDH) in patients refractory to medical management provides rapid and effective symptom relief. However, both short and long term benefits of surgery continue to be scrutinized.

Objective: To compare clinical efficacy of Chiropractic Treatment against Microdiscectomy in patients suffering from sciatica secondary to LDH.

Study Design: Prospective Randomized Controlled Clinical Trial allowing crossover, recruitment 2000-2004, 1 year follow-up.

Setting: Elective primary care physician referrals made directly to neurosurgical spine surgeons at the Foothills Hospital and Medical Centre, University of Calgary.

Patients: Forty consecutive consenting patients with sciatica from LDH refractory to at least three months of non-operative care and found appropriate for surgery.

Interventions: Surgical microdiscectomy or standardized chiropractic treatment. Crossover to the alternate treatment allowed after 3 months.

Main Outcome Measures: McGill Pain Score, Roland Morris Disability Index, Aberdeen Pain Scale, and SF-36 General Health Survey before treatment initiation and after 3, 6, 12, 24 and 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients presenting through elective referral by primary care physicians to one of the three participating spinal neurosurgeons (SC, SJD, RJH) between December 2000 and May 2004 were screened for symptoms of unilateral lumbar radiculopathy secondary to LDH at L3/4, L4/5 or L5/S1. Detailed surgical histories and physical examinations were performed on each referred patient by the consulting neurosurgeon and correlated with evidence of appropriate root compression on MR imaging. Patients who had failed at least 3 months of non-operative management including treatment with analgesics, lifestyle modification, physiotherapy, massage therapy and / or acupuncture, and who were felt appropriate for microdiscectomy by the neurosurgeon were asked to consider study participation.

Exclusion Criteria:

* Radicular symptoms \< 3 months duration
* Major neurological deficits such as:

  * Cauda equina syndrome
  * Rapidly progressing neurological symptoms (e.g. foot drop)
* Substance abuse
* Hospitalization for intravenous or intramuscular narcotics
* Systemic or visceral disease (e.g. auto-immune diseases, major system failure)
* Hemorrhagic disorders, anticoagulation therapy
* Previous surgery at symptomatic level
* Concurrent chiropractic care at time of enrollment
* Prolonged use of systemic corticosteroids
* Osteopenia/Osteoporosis
* Spondylolisthesis grade III or IV
* Unable to read or speak English
* Age \< 18
* Pregnancy
* Dementia or other cognitive impairment
* Unavailable for follow-up (geographic barriers)
Therapy Study of Automated Protocolized vs. Physician-Directed Non-Protocolized Weaning

The purpose of this study was to determine whether computer-driven protocolized weaning is superior to physician-directed non-protocolized weaning in over-24-hours-ventilated surgical intensive care unit (ICU) patients. The main hypothesis was that weaning duration differs between both methods. Secondary hypotheses were that reintubation rate, duration of mechanical ventilation, intensive care unit (ICU) length of stay and workload for physicians and nurses differ between both methods.

Since long-term mechanical ventilation is affiliated with a bunch of complications, weaning affected patients from ventilation as soon as possible is a crucial point. In this context automated computerized systems have become a torchbearer. These systems are expected to expedite the weaning process, reduce the duration of mechanical ventilation and ICU length of stay of a given patient in comparison to conventional physician-directed weaning. A multicenter randomized trial by Lellouche et al supported these theories, using a computer-driven system to regulate Pressure Support Ventilation (PSV). This system is now commercially available as SmartCare/PS (Draeger Medical AG \& Co. KG, Luebeck, Germany).

The purpose of the study on hand was to find out whether the results reported before could be repeated in a broad, surgical ICU patient group. Study design was chosen similar. In addition we investigated the workload for physicians and nurses in both study arms which has not been conducted before.

Eligibility Criteria:
Inclusion Criteria:

* mechanical ventilation \> 24 hours
* intubation OR tracheostomy
* informed consent
* 35 - 200 kg bodyweight (77,2 - 440,9 lb)
* Ramsay-Score \< 3
* spontaneous breathing at a PEEP of \< 10 cm H2O
* sufficient arterial oxygenation (paO2 \> 55 mmHg or SaO2 \> 90%)
* haemodynamic stability (\< 5 µg/kg/min Dopamine)
* body temperature (rectal) max. 39 °C / 102.2 °F
* hemoglobin \> 7 g/dl
* pH \> 7,2
Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.

The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.

Eligibility Criteria:
Inclusion criteria:

* Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.

Exclusion criteria:

* Allergic reaction to vaccine components;
* clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
* immunocompromised.
Wheezometer™ Exploratory (WM) Field Study

Karmel Sonix Ltd has developed the Personal WheezoMeter a hand-held pulmonary sounds analyzer that utilizes contact sensors to acquire, amplify, filter, record and quantify the presence of wheezing. When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed healthcare professional. The device is intended for use with pediatric and adult patients in both home and clinical settings.

The purpose of the study is to determine whether Wz% and change in Wz% correlate with symptoms and change in symptoms at least as well as FEV1 and change in FEV1.0. Additional information to be obtained from the study will be to determine whether there is a symptom threshold at which a patient seeks rescue medications and if so, to determine the value of Wz% and FEV1.0 at this point (Wz%, FEV1.0 thresholds). The study will also provide information on the within patient and whole group correlations between Wz% and FEV.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosed asthma.
* Poorly controlled asthma as per GINA Guidelines with frequent (i.e. \>5/week) use of reliever medications.
* Adequate comprehension level and demonstrated ability to perform unsupervised spirometry, wheezometry and use the symptom diary.
* Age range 8-80. Patients over 40 will only be included if they are lifetime non-smokers, who have demonstrated reversibility of airway obstruction (at least 12% improvement in FEV1.0 after bronchodilator).
* All patients included in the study will be routinely receiving either a short acting bronchodilator or a long acting bronchodilator twice daily as part of their regular medication. Additional doses of bronchodilator will be taken on an as needed basis. No change in regular medication will be made for the purposes of the study.
* Subject or subject's parents/guardians is/are able to comprehend and give informed consent for participation in the study.

Consent of treating physician.

Exclusion Criteria:

* Inability to perform spirometry and/or Wheezometry. Skin Disorder (burn, infection, or allergy) over upper chest (Child) or neck (Adult).
* Patients with other diseases, which in the opinion of the treating physician would interfere with the management of asthma and performance of the study according to the protocol.
* Hospitalization at recruitment, \[patients who get admitted while participating will continue to participate\].

P- hysician objection.
Blood Donation--Immune Sequelae and Recruitment

To determine if there were immune sequelae related to the long-term donation of blood or blood products.

DESIGN NARRATIVE:

The study had two objectives. The first objective was to investigate changes in immune function which may have occurred as a result of blood, plasma, or platelet donations. Preliminary studies had shown evidence of alterations in immune parameters in normal apheresis donors with the most marked changes occurring in long-term plasmapheresis donors. To ascertain whether donation of blood or blood products altered specific immune parameters, studies were conducted on white blood cell (WBC) receptors known to be involved in normal host defense mechanisms, lymphocyte subpopulations, plasma proteins, and complement activation products from 30 individuals in each of four separate donor groups: whole blood donors, bulk plasma donors, plasma donors stimulated with incompatible RBC, and platelet donors. Donor immune data were compared with results in nondonor controls and were also correlated with demographic data, donation history, laboratory data, and clinical findings. The second objective of the study was to determine if changes in an individual donor's immune status occurred over time. A longitudinal study of 15 new donors in each donation group was performed to evaluate alterations in immune function that may have occurred in committed donors of blood products and whether there was any clinical significance to the findings. New donors were enrolled in donation groups and followed longitudinally for a period of up to two years.

The study was extended through January, 1997 on FY 1995 funds.

Eligibility Criteria:
No eligibility criteria
Bioequivalence Study in Healthy Subjects

This study is designed as a Phase-I, 2-period, cross-over, randomised, open-label, single centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial oral suspension of candesartan cilexetil (1 mg/mL) and a single 32 mg dose of the candesartan cilexetil oral suspension (1.6 mg/mL) used in the paediatric program.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Body mass index (BMI) 19-27 kg/m2 calculated from height and weight at the Screening visit
* Clinically normal physical findings including ECG and safety laboratory values at the Screening visit and on Day -1 of each treatment period, including negative results for drugs-of-abuse, alcohol, Hepatitis B, Hepatitis C and HIV.

Exclusion Criteria:

* History of significant mental, cardiac, renal, hepatic or significant gastrointestinal disease (that may affect the rate and extent of absorption of the IP), as judged by the Investigator
* Any condition which could modify the absorption of the IPs
* Previous randomisation of treatment in the present study
* History or symptoms and signs of ongoing severe allergic disease/hypersensitivity