cyrilzakka/clinical-trials huggingface dataset:
Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149) on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) stage II or stage III according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2009)
* Qualifying spirometry, Forced Expiratory Volume in one second (FEV1) and post-bronchodilator FEV1/FVC (Forced Vital capacity)
* Smoking history ≥ 10 pack years

Exclusion Criteria:

* Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception
* Cardiac abnormality
* History of asthma
* Contraindications to cardiopulmonary exercise testing
* Participation in active phase of pulmonary rehabilitation program
* History of cancer within the past 5 years

Other protocol-defined inclusion/exclusion criteria may apply
Marker Technique Comparison in Targeted Axillary Dissection

Comparison of two methods (Magnetic Marker and standard metal clip) used for localisation and extraction of lymph nodes in Targeted Axillary Dissection (TAD) in patients with breast cancer.This Project will investigate and compare the duration of intervention, detection rate and safety.

The participants will be randomized into two groups of equal size.

This Project will investigate and compare the duration of intervention, detection rate and safety of two methods (Magnetic Sirius Pintuition Marker and standard metal clip) used for the localisation and extraction of lymph nodes in Targeted Axillary Dissection (TAD).

The participants will be randomized into two groups of equal size. The groups differ in terms of the method used to mark the lymph nodes prior to TAD. One group will receive a metal clip (HydroMARK© Clip), which will be localized and extracted during the tailoring surgery. Intraoperative Ultrasound is used to localize the clip. This method is considered as standard practice today.

The second group will receive Metal Clip (Sirius Pintuition) to localize axillary lymph nodes during TAD. Intraoperative localization of the lymph node will be conducted using a hand-held probe.

Successful localization of the lymph node, duration of the intervention (beginning of the localization until successful extraction) and adverse effects will be documented.

Eligibility Criteria:
Inclusion Criteria:

* Indication: Patients undergoing lymph node marking before targeted axillary dissection due to suspicious lymph nodes or confirmed lymph node metastasis in breast cancer patients
* Female participants ≥ 18 years of age
* The subject was informed about the project and gave her written informed consent to use her data and samples for this project.
* BMI \< 30
* Indication for neoadjuvant chemotherapy

Exclusion Criteria:

* Not fulfilling inclusion criteria
Retrospective, Non-significant Risk, Deep Brain Stimulation (DBS) Care Management Software Feasibility Study

To evaluate DBS device settings and match with the features of the DBS care management software.

This is a study done on Parkinson disease subjects who have received the DBS system implanted in their subthalamic nucleus.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Medtronic Deep Brain Stimulation therapy for idiopathic levodopa responsive Parkinson's Disease
* Patient who has had lead placement in the Subthalamic nucleus
* Patient with pre-op MRI available
* Patient with post-op CT scan available showing placement of the lead
* Patient who has documented improvement of at least 35% on UPDRS III scores from baseline preoperative off medication state compared to post DBS implant stimulation on/medications off

Exclusion Criteria:

* Patient who has had clinically significant persistent stimulation related adverse effects
* Patient who has evidence of lead migration without lead revision
* Patient with other brain malformations that would make it difficult to process images (ablative surgery in the basal ganglia, resective surgery, brain tumor)
Study to Investigate the Effects of Krill Oil on Fasting Serum Triglycerides

The purpose of this study is to assess the effect of 12 weeks of daily supplementation with Superba(TM) Krill Oil on fasting serum triglyceride levels and omega-3 index in subjects whose habitual fatty fish and seafood intake is low and who have borderline high or high fasting serum triglyceride levels.


Eligibility Criteria:
Inclusion Criteria(not limited to):

* General good health with no existing co-morbidities
* Body mass index (BMI) less than 35 kg/m²
* Borderline high or high fasting serum triglycerides
* Clinically normal findings for hematology, clinical chemistry, and urinalysis
* Be willing to maintain dietary habits and physical activity levels throughout the trial period (next 4 months)
* Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less

Exclusion Criteria (not limited to):

* Familial hypercholesterolemia or severely high total cholesterol levels
* History or presence of significant cardiovascular disease or co-morbidities
* Known allergy to crustaceans (shellfish)
* Bleeding disorders
* Disturbed absorption due to changes in the gastrointestinal tract
* Participation in a clinical trial with an investigational product within 30 days before screening
* Present or recent use (within 3 months of screening or the first screening visit, if applicable) of any medication which is a known lipid modifying agent or any dietary supplements that affect the level of blood cholesterol and triglycerides
* Current or recent diet, which in the opinion of the Investigator, deviates from a normal diet (e.g., vegetarians may be acceptable, vegans are not acceptable)
* Female patients that are pregnant or nursing or females of childbearing potential who are not on a method of birth control acceptable to the Investigator during treatment
* Patients with known coagulopathy or receiving anticoagulant therapy or co-morbidity that would interfere with the study results
* Frequency of fatty fish and/or seafood consumption is greater than twice per month
* Present or recent use of any long-chain omega-3 fatty acid supplement
* Peri-menopausal women or post-menopausal women taking hormone replacement therapy
* Patients who test positive for human immunodeficiency virus (HIV) or hepatitis B or C
* Systolic blood pressure greater than 159 mmHg or diastolic blood pressure greater than 99 mmHg or use of anti-hypertensive medication
* Diabetic subjects
* Staff of Cetero Research
Effects of Intra-uterine Slow-Release Insemination on Pregnancy Rate in Women Designated for Artificial Insemination

A couple that does not achieve pregnancy though regular attempts for a year are defined infertile couple. This condition is caused by faulty functioning of the reproduction system of the husband or wife or both. If there are no organic defects and there is no definite injury to the reproductive system (ova or spermatozoa), the specialist doctor generally decides to put the couple into a fertility treatment program. Artificial insemination is one of the important ways of achieving pregnancy.

Three common methods of artificial insemination:

1. Placement of a diaphragm that contains raw spermatozoa or isolated improved spermatozoa in an appropriate liquid solution (Cup insemination, CI) upon the cervix.
2. Spermatozoa injection (after improvement) through the vagina to the cervix (Intra-Cervical Insemination, ICI).
3. Spermatozoa injection (after improvement) directly into the uterus (IUI-Intra-Uterine Insemination).

The EVIE - Slow Release Insemination method:

The slow release insemination is utilizing a Grasby type MS16 pump for 3 hours. The release rate for motile spermatozoa is 50X103 per minute.

Advantages:

* Very close approximation of the natural procedure in which the spermatozoa arrive to the fertilization site over a long period.
* An extended "window of opportunities" for meeting between the ovum and spermatozoa will be longer.
* There is no loss of spermatozoa due to leaking as sometimes happens with single-time injection practiced in the IUI method.

Primary Endpoint:

Accumulation of 50 cycles of SRI- slow release insemination (study group) in addition to 50 cycles of regular IUI (control group). Two weeks after insemination Beta hCG test

Secondary Endpoints:

Four weeks after insemination - US Viability scan

Procedure:

Subjects will be women with fertility difficulties who are designated for IUI treatment. 100 insemination cycles will be conducted. (50 regular IUI and 50 EVIE-SRI). Subjects that were treated with the IUI method and who does not become pregnant will then be treated with the EVIE-Slow Release method and vice versa.


Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary infertility designated for IUI treatment.
* Age of candidates: 20-40 years.
* Normal uterus x-ray.
* Women suffering from infertility on a background of non-ovulation.
* Infertility on a background of male problems (over 10 million of motile sperm cells per sample).
* Infertility on background of unexplained problem
* Same sex patients / single patient
* Written informed consent

Exclusion Criteria:

* Woman under the age of 20 or over the age of 40 years.
* Female infertility on mechanical background (different blockages, irregular uterus).
* Infertility on male background of medium to very low level of spermatozoa - less than 10 million motile sperm cells per sample.
* Men and women who are opposed to the random spermatozoa insemination method.
* Participants who are not willing to sign the Consent Form.
Peripherally Inserted Central Catheter Placement by Interventional Radiologists Using the Sonic Flashlight

The purpose of the study is to perform the first clinical trial on human subjects using the Sonic Flashlight (SF) to guide placement of Peripherally Inserted Central Catheters (PICCs).

The SF prototype is an ultrasound (US) display device under development at our institution that replaces the traditional US monitor by using a half -silvered mirror to reflect real-time US images into the body. When the operator looks through the half -silvered mirror, the US image appears to float beneath the surface of the skin, exactly where it is being scanned. The SF merges the US image, probe, needle, operator's hands, and patient into the same field of view, making procedures more intuitive to the novice user, in contrast to conventional US (CUS) guided procedures, where hand-eye coordination is displaced, forcing the operator to look away from the field to see the US screen. We have previously shown that VA in phantoms is easier to use, faster to use, and faster to learn than CUS in novice and experienced US users. The current SF prototype uses a 10MHz US system (Terason, Burlington, MA) modified by attaching a small flat-panel display (AM550L OLED, Kodak, Rochester, NY) and a 20x50x1mm half -silvered mirror to the probe. A standard, clear, sterile polyethylene US probe cover was placed over the entire SF to sterilize the device. 15 subjects needing PICC lines were enrolled in this study. Scanning the upper arm of each patient with the SF, the basilic vein, brachial vein, and brachial artery were identified on the in situ US image. A 21ga needle was guided into the basilic or brachial vein. The number of attempts, or sticks, per PICC line placement, specific vein accessed, and reason for a failed attempt were recorded.

The vasculature was clearly visualized in situ using the SF. The needle was aimed and easily inserted into the basilic or brachial vein, and the needle tip visualized at its expected location. Successful vascular access was obtained with all 15 subjects, 13 of 15 on the first attempt, and 2 of 15 on the second attempt. 3 of the 15 lines encountered mild blurriness looking through the SF due to inconsistent optical properties of the probe cover.

This study shows that venous access can be obtained using the SF. Once the optical problems with the probe covers are addressed, the SF will be ready for a larger clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Undergoing a PICC line insertion as part of their standard care

Exclusion Criteria:

* None
Role Of Non-Specific Effects in The Treatment of Depression With Esketamine

The investigators aim to examine the magnitude of non-specific effects in the treatment of depressive episodes with esketamine, by providing patients in the intervention group with a pretreatment presentation and post-treatment follow up session, to assess whether nonspecific effects can be used effectively to improve the effectiveness of treatment with esketamine.

Primary Objective:

To determine whether a positive presentation before first treatment improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment.

Secondary Objectives:

To determine whether a post-treatment follow up session to provide encouragement and reassurance improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment.

To determine whether a positive presentation results in an improved response from treatment in patients receiving esketamine for a depressive episode as measured by MADRS score within 24 hours after the first treatment.

To determine whether a positive presentation before first treatment, combined with a posttreatment follow up session after first treatment, result in an improved response from treatment in patients receiving esketamine for a depressive episode as measured by MADRS score by the end of the acute course of esketamine treatment.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be either male or female and at least 18 years old
* Deemed clinically appropriate to receive esketamine by a Yale Interventional Psychiatry physician.
* Written consent for the study procedures
* Ability and willingness, in the investigator's judgement, to comply with the study schedule, treatment plan, and other trial requirements for the duration of the study.

Exclusion Criteria:

* Hearing or visual impairment to the degree that would interfere with ability to view the presentation
* Difficulty in understanding spoken or written English
* Unable to provide informed consent
* Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the presentation (per investigator judgment)
* Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
* Previous Esketamine or ketamine treatment
* Unable to give informed consent
* Was previously enrolled/randomized into the trial
A Clinical Evaluation of the OrSense Non-invasive Blood Hb/Hct Measurement Instrument, the Hemo-Monitor NBM200/MP

The purpose of the study is to define the precision, accuracy and variability of the NBM-200 system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.

Each subject will be placed in a comfortable position in a temperature regulated room. Participants will have two consecutive non invasive (NBM) measurements taken which involves inserting the thumb into a ring shaped sensor. After each non invasive measurement the sensor will be removed. Each measurement takes approximately 85 seconds and involves the finger cuff inflating (to over systolic pressure) and deflating several times in quick successions in order to measure and calculate the Hb values. The two non invasive measurements will be performed using the same finger. After the NBM system testing is complete and recorded, the subject will have a venous (venipuncture) blood sample collected in order to provide two blood tests performed on two different models of routine automated complete blood count or Hb blood analyzers.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 years and over

Exclusion Criteria:

* Participants under the age of 18 years
* Patients with significant deformity, degenerative changes or oedema of the fingers or hand
* Patients with localized infection, ulceration or skin breaks involving the fingers
* Patients with vascular disease or Raynaud's phenomenon affecting the fingers (vasospasm)
* Participants who are unable to give informed written consent
The Investigation of the Impact of Early Mobilization on the Outcome in Patients With Aneurysmal Subarachnoid Hemorrhage.

The goal of the randomized clinical trial is to examine the effect of early mobilization on primary and secondary outcomes in patients with subarachnoid hemorrhage caused by aneurysm rupture.

Researchers will compare early mobiliziation vs. standrad bed rest care.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 ys
* Premorbid modified Rankin Scale score of 0-2
* WFNS I-IV at enrollment
* Aneurysm occlusion has occurred through open or endovascular means
* Minimum 24 hours elapsed after aneurysm occlusion
* The patient has not received thrombolytic therapy
* Vital parameters are appropriate (mean arterial pressure \[MAP\] \>80 or \>110 mm Hg)
* Signed patient information and consent form
* Enrollment occurs within 72 hours following ictus

Exclusion Criteria:

* Age under 18 years
* Traumatic subarachnoid hemorrhage
* Incapacitated or limited capacity for action before ictus
* Confirmed pregnancy
* Aneurysm multiplicity (unless all aneurysms are treated)
Anxiety-depressive Disorder in Primary Care and Cognitive-behavioral Treatment

OBJECTIVE: Evaluate the effectiveness of quality of life score, a cognitive-behavioral intervention by psychologists in the field of primary care in anxiety-depressive patients, mild to moderate, compared with usual care.

DESIGN: Clinical trial, multicenter, prospective, and randomized into two parallel groups. SCOPE AND SUBJECTS: We included a random sample of 246 patients anxious-depressive, mild / moderate, belonging to the target population of 41 doctors from several health centers. INTERVENTION: In the 246 patients randomly assigned to the intervention group, with a standardized program of cognitive behavioral therapy applied by psychologists, by the usual treatment or control group, which will be standard care. MEASUREMENTS: The main result will be changes in general health scores of the SF-36. It will also measure the change in frequency and intensity of anxiety-depressive symptoms on the scales HARS, HDRS, STAI and BDI at baseline and at 2, 6 and 12 months. In addition, also collected for drug use and health services.

ANALYSIS: Analyses were performed by intention to treat, comparing the change obtained in both groups at the end of the 12 month follow up. Estimates of the effect attributable to the intervention by the difference in those changes, adjusting in addition to the baseline, the possible confounding covariates or effect modifiers of the intervention, using longitudinal mixed-effects models.


Eligibility Criteria:
Inclusion Criteria:

* Primary care patients.
* Adults.
* Of both sexes.
* With disorder mixed anxiety-depressive mild-moderate active diagnosed by their general practitioner and showing more than 4 points in Goldberg-Anxiety, and more than 3 in Goldberg Depression.

Exclusion Criteria:

* Patients under 18 or over 75 years
* Patients with inability to understand, read or speak Spanish
* Patients with cognitive impairment
* Patients with severe disease which in the opinion of your doctor have a presumably fatal end during the 12 month follow-up
* Patients with psychotic disorders or other serious mental disease
* Patients with attempted suicide or suicidal ideation persistent
* Patients referred to Specialized Care
* Patients who are in private treatment
* Patients with high probability of loss to follow up.
Non-automatic Control of Gait and Posture in Obstructive Sleep Apnea Syndrome (CIH-Gait)

The purpose of this randomised controlled study is to determine the impact of continuous positive airway pressure (CPAP) versus sub-therapeutic CPAP (placebo) on the control of gait upon severe sleep apnea patients, based on stride time variability.

As severe sleep apnea patients exhibit gait abnormalities, this is the first randomised controlled trial to our knowledge to assess the impact of CPAP upon gait and postural control in severe sleep apnea patients. Based on a dual-task paradigm, posture and gait analysis will be perform before and after 8 week of intervention.

Beside gait parameters, the cerebral metabolism will be assessed using a Near Infrared Spectroscopy (fNIRS) device during normal walking and during walking while dual-tasking, using a visual and a verbal task.

Eligibility Criteria:
Inclusion Criteria:

* Normally weighted or over-weighted patients (BMI \< 30 kilograms/m²)
* Newly diagnosed Obstructive Sleep Apnea Syndrome (OSAS) (i.e. no previous treatment)
* Severe OSAS as defined by the American Academy of Sleep Medicine (AHI ≥ 30)
* To speak and understand french
* To be affiliated to social welfare

Exclusion Criteria:

* Age criteria : \<18 year old and \>70 year old
* Obesity (BMI ≥ 30 kilograms/m²)
* Pathological conditions thought to be responsible of gait unsteadiness and postural sway or requiring an walking device : nervous system disease (Parkinson disease, chronic stroke), cerebellum syndrome, vestibular syndrome, orthopaedic and rheumatic diseases,
* Lower limb sensitivity impairment,
* Cognitive disorder (Folstein test score \< 24),
* Ophthalmology disorder : uncorrected refractive disorder, disturbance of color vision,
* Psychotropic treatment intake,
* Alcoholism,
* Member of an at-risk occupation (car, bus, truck drivers...) mandating effective continuous positive airway pressure introduction.
Determination of the Effect of Cold Needle on Invasive Pain Cannulation

In studies evaluating the methods used to reduce invasive pain associated with cannulation, it is seen that pharmacological and non-pharmacological methods are used. Pharmacological treatment is considered risky as it may cause drug addiction in the patient and may cause side effects and complications. On the other hand, the use of non-pharmacological methods is preferred because they are cheaper and cause fewer side effects and complications.

Cold application, one of the non-pharmacological methods used, is effective in relieving pain by slowing down or blocking the conduction of peripheral nerves. Apart from this effect, it stimulates touch receptors by activating the Door-Control mechanism; It increases the release of endogenous opioids and stops pain by ensuring the nerve impulses caused by cold are transmitted to Delta fibers. Although studies conducted on hemodialysis patients have shown that cold application is effective in reducing pain; Due to the small number of sample groups and deficiencies in the methodology, it was suggested that further studies be conducted. In these studies, cold application; It was applied to the area one cm above the fistula or between the thumb and index finger of the opposite arm, using an ice pack and an ice-filled glove for 2-10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 years and older
* had been treated with HD for at least 3 months, thrice a week, and for 4 hours per session
* did not have a psychiatric disorder that would prevent communication
* volunteered to participate in the study

Exclusion Criteria:

* Patients who were known to present difficulties when entering the fistula (requiring multiple cannulations)
* had a history of hematoma or stenosis in the AVF
* had an infection at the fistula site
* took painkillers within 3 hours of treatment
* did not want to participate in the study