cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects

This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment compared to matched healthy subjects with normal liver function.


Eligibility Criteria:
Inclusion criteria:

* Male or female, 18 to 70 years of age, in good health
* Stable Child-Turcotte-Pugh score of at least 5
* Body weight of at least 50 kg and a BMI of 18.0 to 36.0 kg/m2

Exclusion criteria:

* Use of other investigational drugs
* Women of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply
Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)

The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks.

A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to Visit 2 (final visit at the end of the study, approx. 6 weeks after Visit 1), as well as patient satisfaction with Spiolto® Respimat® at Visit 2.


Eligibility Criteria:
Inclusion criteria:

1. Written informed consent prior to participation
2. Female and male patients = 40 years of age
3. Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and COPD GOLD guideline recommendation

Exclusion criteria:

1. Patients with contraindications according to Spiolto® Respimat® SmPC
2. Patients who have been treated with a Long-acting beta2 adrenoceptor agonist\\Long-acting muscarinic antagonist (LABA/LAMA) combination (free and fixed dose) in the previous 6 weeks.
3. Patients continuing Long-acting beta2 adrenoceptor agonist Inhalative Corticosteroids (LABA-iCS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
5. Pregnancy and lactation
6. Patients currently listed for lung transplantation
7. Current participation in any clinical trial or any other non-interventional study of a drug or device Further exclusion criteria apply
Study on the Effectiveness of EGb 761® vs Placebo Used for Cognitive Impairment in Patients With Multiple Sclerosis

The purpose of this study is to determine whether the use of EGb 761 by patients with Relapsing-Remitting Multiple Sclerosis is effective in improving cognition, when compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Multiple Sclerosis Relapsing-Remitting form
* Patient with cognitive impairment (as spontaneous complaint by either patient or family)
* Patient treated with interferon and maintaining same dosage for previous 6 months
* Patient without major disability (Kurtzke Extended Disability Status Scale ≤6)

Exclusion Criteria:

* Clinical Multiple Sclerosis relapse within 3 months prior to participation
* Major psychiatric disease according to Diagnostic and Statistical Manual of Mental Disorders, 4th Ed.
* Other concomitant disorders possibly jeopardizing the cognitive status evaluation or the follow up of the patient (severe impairment of visual or motor function which may prevent participation in neuropsychological testing)
Effectiveness of Nursing Orientation for the Reduction of Anxiety and Stress

This study´s objective was to identify the effectiveness of nursing orientation for the reduction of anxiety and stress of patients that was waiting cardiac catheterization. Method. This is a randomized clinical trial. The sample consisted of patients that was waiting cardiac catheterization who were divided into two groups: intervention group (patients who received nursing orientation with a validated guidance manual about this procedure) and control group (patients who received the routine nursing orientation). The primary end points were the anxiety and stress, which was evaluated in two moments (before and after the nursing orientation). The State Anxiety Inventory (STAI-state) was used to assess anxiety and the Perceived Stress Scale (PSS-10) was used to assess stress. Prior to the collection, the research project was submitted to the Research Ethics Committee and the data was collected after its approval.

This study´s objective was to identify the effectiveness of nursing orientation for the reduction of anxiety and stress of patients that was waiting cardiac catheterization. Method. This is a randomized clinical trial. The sample consisted of patients that was waiting cardiac catheterization who were divided into two groups: intervention group (patients who received nursing orientation with a validated guidance manual about this procedure) and control group (patients who received the routine nursing orientation). The subjects were consulted about the desire to participate, and those who agreed, signed the consent form. The patients were randomized to one of two groups (control or intervention), according to the sequence determined by the Random System. Randomization was carried out by a teacher who did not participate of any phase of this study. After randomization, the patients were instructed how to fill out the instruments. The primary end points were the anxiety and stress, which was evaluated in two moments (before and after the nursing orientation). The State Anxiety Inventory (STAI-state) was used to assess anxiety and the Perceived Stress Scale (PSS-10) was used to assess stress. Subsequent to this first evaluation, the patients, both in the control group and in the intervention group, received the intervention by another profissional. After the patients were evaluated about anxiety and stress. Prior to the collection, the research project was submitted to the Research Ethics Committee and the data was collected after its approval.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 18 years
* Literate
* Stable patients in Killip I and II
* Maximum 79 years

Exclusion Criteria:

* Hemodynamic instability
* Precordial pain
* Patients who undergo emergency cardiac catheterization
* Patients with visual deficit and / or with some alteration of the level of consciousness
* Patients using benzodiazepine, anxiolytic and / or herbal medicines
* Situations that patient received orientation about the procedure prior to initiation of the current hospitalization survey and / or when reporting that they do not wish to receive information.
A Study of Xiongdan Wan Treating Depression

This is a prospective, single-arm, open-label study to evaluate the safety and efficacy of Xiongdan Wan monotherapy in patients with Major Depressive Disorder(MDD), conducted in Shang Hai Mental Health Center. Following a screening period, subjects who meet the entry criteria will be treated with 450mg Xiongdan Wan pills three times daily for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Meets the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD): a single or recurrent episode without psychotic features. Codes are as follows: F32.0, F32.1, F32.2, F33.0, F33.1, F33.2.
2. Outpatients.
3. Male or female subjects aged 18-65 years.
4. HAMD-17 score of the baseline period and screening period is 18-24.
5. Women of childbearing potential must be willing to use acceptable methods of contraception throughout the study period and the following one month.
6. The patient fully understands and signs the informed consent form.

Exclusion Criteria:

1. Patient has survived a suicide attempt or has acute suicidal tendencies (HAMD-17 Item3 ≥3).
2. Comorbidity according to DSM-IV-TR, axis-I except for major depressive disorder.
3. HAMD-17 reduction ratio ≥25% within one week from the screening to the baseline period.
4. Depressive episode secondary to psychiatric illness or somatic disease.
5. Serious and unstable diseases such as cerebrovascular disease; liver and kidney disease; disease of internal secretion (abnormal thyroid function); hemopathy; seizures, or other encephalopathies.
6. History of alcohol or drug abuse over the last 6 months.
7. Allergic history to Xiongdan Wan, or serious drug allergic history.
8. Pregnant or lactating women and women of childbearing potential throughout the study period; men who have the desire of fertility within six months.
9. Clinically significant changes in ECG or laboratory tests, including \>1.5 times the upper limit of normal liver function; over the limit of normal renal function and blood sugar; abnormal cardiac troponins; obvious abnormity in the thyroid function.
10. Treatment with modified electroconvulsive therapy (MECT) or repetitive transcranial magnetic stimulation (rTMS) in the past three months.
11. Treatment with a systematic psychological treatment in the past three months.
Transcranial Magnetic Stimulation in Stroke Motor Rehabilitation Treatment

The goal of the study is to determine the effect of repetitive transcranial magnetic stimulation (rTMS) over the premotor cortex on training-related improvements in motor performance and associated neural plasticity.

Occlusion of the middle cerebral artery is the most common cause of stroke. Because the middle cerebral artery supplies blood to the motor cortices, middle cerebral artery stroke often impacts the integrity of the motor cortex and its associated corticospinal projections. Less than half of all individuals post-stroke regain complete motor function. Because motor deficits, especially of the upper extremities, can dampen the quality of life, there is an urgent need to improve current rehabilitation programs to allow more stroke survivors to achieve higher functional gains.

Motor training is an important part of recovery after stroke. During motor training, patients practice performing a movement and become better at performing the trained movement over time. Repetitive transcranial magnetic stimulation (rTMS), which uses magnetism to excite neurons near the surface of the brain, may further improve performance. There is evidence that the premotor cortex may be a more effective target than the primary motor cortex for rTMS for some stroke survivors. In the current study, the investigator will determine the effect of rTMS over the premotor cortex on training-related improvements in motor performance in adults who experienced a stroke more than 6 months ago.

Eligibility Criteria:
Inclusion Criteria:

* Have the ability to give informed, written consent
* Be aged 30-80 years old
* Have a single ischemic infarction affecting the primary motor system
* Have intact cognitive abilities
* No current depression
* No neurological disease
* No contradictions to TMS

  * No history of seizures or epilepsy
  * No implanted medical device
  * No metal in neck or head
  * No history of migraine headaches
  * No intake of medication that lowers seizure threshold

Exclusion Criteria:

* none
Silicone vs Pirfenidone in the Treatment of Hypertrophic Scars and Keloids

Justification:

Keloid scars are a major medical and cosmetic problem, especially in darker skin types that predominate in Mexico. It is estimated that hypertrophic scars affecting from 1.5 to 4.5% of the general population. However, the exact prevalence is unknown but studies show that going from 32 to 67%. And there are studies documenting that this prevalence is higher in Hispanic and black individuals and in the pediatric population.

Keloid scars can become highly symptomatic disfiguring and which affects the quality of life of patients and their self-esteem.Problem Statement:

Is silicone gel solutions superoxidation with equal or better than the gel 8% pirfenidone to treat keloids and hypertrophic scars?

Goal:

To evaluate the efficacy of a silicone gel-oxidation with solutions compared to a gel containing 8% pirfenidone.

Hypothesis:

If the silicone gel solutions superoxidation is equal or better than gel 8% pirfenidone to treat keloids and hypertrophic scars, then the reduction in the ECV and the EVA will be similar in the first group than the second.

Design:

Comparative, observer blind, experimental and prospective study.

This is a comparative, non-inferiority, experimental, prospective, longitudinal pilot study with blind evaluator, in patients with keloid or hypertrophic scars. Twenty patients per group randomly assigned to receive identical tubes of either a silicone-based gel with superoxidized water, or an 8% pirfenidone gel. Follow-up was scheduled at 2, 4, 8, 12, and 16 weeks recording the location, mechanism of the scar, time of evolution, skin phototype, accompanying symptoms, Dermatology Life Quality Index, and validated scar assessment tools (Patient and Observer Scar Assessment Scale, Vancouver Scar Scale, and the Analog Visual Scale for Keloids).

Eligibility Criteria:
Inclusion Criteria:

* keloid or hypetrophic scar

Exclusion Criteria:

* collagen diseases pregnancy previous treatment for 3 months
Prospective Clinical Trial of Onlay-carrying Patients

A record of the type of onlay will be made with respect to its extension, tooth or teeth to be treated, the material of clothing and the substrate on which the adhesion and cementing method, as well as the type of antagonist. To complete it, a complete clinical oral examination will be performed with oral mirrors, examination probes, joint paper, disposable gloves, masks, paper napkins, plastic cups, dental equipment lighting lamp, cold spray , photogrammed camera, including an intraoral scan to have a 3D file of the patient's condition on the day of embedding placement.

Once treatment is complete, the patient should go to routine check-ups in which a full intraoral exploration and data collection intended to be carried out analyze the following variables (USPHS modificated): possible decemented and fractured, decay and marginal integrity, sensitivity or loss of vitality, as well as the degree of patient satisfaction (VAS).

The same intervention will be carried out during the duration of the project, collecting the variables:

* baseline recall. (cementing day)
* 1 month.
* 6 months.
* annually.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:
* Healthy adult patients (ASA I) susceptible to treatment with onlays in the posterior region treated at the University Dental Clinic (Master's Clinic in Dental Prosthetics of the Department of Stomatology of the Faculty of Medicine and dentistry)

Exclusion Criteria:

* Minor patients.
* Medically committed patients.
* Patients with active cavities.
* Patients with active periodontal disease.
Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

The treatment of extra-articular distal radius fractures is still controversial. In Canada, most patients with unstable fractures are treated with pinning and cast. Results are often associated with shortening and lack of function.

The purpose of the study is to compare stabilization with a radio-radial fixator to the usual method, suggesting that the radio-radial fixator will provide more strength at 6 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Distal radius fracture Frykman I or II
* Unstable fracture according to Lafontaine's criteria
* Fracture line more than 1cm form the joint line
* Closed fracture
* Age \> 18 years
* Surgery performed between 72 hours from the trauma
* Monotrauma
* Patient signed the informed consent

Exclusion Criteria:

* Distal radius fracture Frykman III-VI (intra-articular fracture)
* Open fracture
* Polytraumatism
* Stable or non-displaced fracture
Tolerance and Prebiotic Activity of Arabinoxylan-Oligosaccharides in Healthy Subjects

The purpose of the study is to evaluate the tolerance of a higher dose of arabinoxylan-oligosaccharides (AXOS) and their prebiotic activity in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* 18-45 years
* regular eating pattern

Exclusion Criteria:

* gastrointestinal complaints
* antibiotic intake
* medication influencing gut transit or microbiota
* abdominal surgery
* pregnancy
Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.

Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary Objective is to compare the efficacy and safety profiles of the two regimens in elderly renal transplanted patients.

The use of tacrolimus-based primary immunosuppression in elderly renal transplant recipients is efficacious and safe, particularly in combination with MMF, and seems to be associated with lower mortality and graft loss rates than classic cyclosporin protocols. Nevertheless, the efficacy and safety of tacrolimus in monotherapy, double or triple therapy with MMF, as well as the induction therapy with the new anti-IL2 receptor antibodies have not been adequately used in controlled trials in the elderly renal transplant patient. There is only scarce information on age-associated immune responsiveness and only a few aged-adapted immunosuppressive regimens have been described.

Eligibility Criteria:
Inclusion Criteria:

* Patients with minimum 60 years of age and end stage kidney disease who are suitable candidates for primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible ABO blood type can be included.

Exclusion Criteria:

* Patient has an immunological high risk
* Cold ischemia time greater than 30 hours.
* Patient has significant liver disease
* Patient is allergic or intolerant to study medication
* Patient or donor is known to be HIV positive.
* Patient with malignancy or history of malignancy
* Patient has significant, uncontrolled concomitant infections
Use of Compressed Sensing in Breast MRI

Breast MRI is increasingly important in breast screening imaging. It is currently based on dynamic sequences after contrast injection whose temporal resolution must be less than 90 seconds with dynamic acquisitions at different times.

These curves profiles are designed to differentiate benign from malignant lesions. Recently, Mann et al, (2014) showed that increasing the temporal resolution of dynamic acquisitions; lesion enhancement curves over time were more accurate than the curves usually performed.

It seems necessary to work on sequences having better temporal resolution without compromising however spatial resolution.


Eligibility Criteria:
Inclusion Criteria:

* Patient to benefit a MRI in the assessment for a breast carcinoma
* Age \>18 years old
* Assessment on 3.0 Tesla in Magnetic Resonance Imaging
* ECOG performance status ≤ 3
* Ability to provide an informed written consent form

Exclusion Criteria:

* Age \< 18 years old
* Claustrophobia
* Contraindication to the injection of gadolinium contrast medium
* Contraindication to MRI
* Persons deprived of liberty or under supervision
First Trimester of Pregnancy: Impact of a History of Miscarriage on Women's Stress

Miscarriage is the spontaneous termination of pregnancy before 22 weeks of amenorrhea. The most frequent complication of pregnancy, it represents 10 to 25% of pregnancies and affects one in four women.

Miscarriage is considered by medical personnel to be common and trivial. however, for women, it is very often a traumatic event, a source of worry for futures pregnancies.

The aim of the study is to evaluate association between history of spontaneous termination of pregnancy and women's stress during the first trimester of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* female
* pregnant (positive plasma HCG)
* in the first trimester of pregnancy
* aged 18 years old and more
* agreeing to participate in the study

Exclusion Criteria:

- less than 18 years old
Leak Pressure After Reinforcement in Gastric Specimens

The investigators hypothesize that staple line reinforcement will result in a higher leak pressure than a non-reinforced staple line closure in the resected gastric specimens from laparoscopic sleeve gastrectomy. The primary endpoint of the study is leak pressure after various staple line treatments. The investigators will also analyze the most common site of specimen leak, association of stomach thickness to leak, association of stomach thickness to performance of the staple line techniques, and a cost analysis.

The purpose of this study is to evaluate the mechanical strength of various staple line reinforcement techniques using the resected portion of stomach in patients undergoing laparoscopic sleeve gastrectomy. The specimen will be collected at the time of surgery, the previous staple line will be excised, and a new staple line with one of the investigatory reinforcement procedures will be applied. The staple line techniques to be used in this study include non-buttressed and non-imbricated oversewing, non-buttressed and imbricated suture line, buttressed stapling, and no reinforcement (see protocol for description of each). The specimen will then be taken to the morgue where the experimental procedure will be performed within 6 hours of specimen procurement. The specimen will be attached to a catheter with a pressure monitor and blue dye will be instilled into the specimen until leakage is seen. The presence of leakage indicates failure of the staple line. Detailed measurements of all specimens will be performed as will leak pressure and location in the specimen where leak occurred. The specimen will then be turned over to pathology to undergo routine pathologic examination.

This experimental procedure has been used previously in published literature with animal samples, but never with human tissue. A possible reason for the lack of testing in the stomach staple line in patients after sleeve gastrectomy is that the technical aspects of bariatric surgery were developed using gastric bypass; a procedure where the stomach is divided but not excised.

The investigators hypothesize that the specimens treated with staple line buttressing material will fail at a higher pressure than those without reinforcement. The investigators will also explore the location of the failure to determine if there is a consistent site of weakness. Should this study yield consistent results, it would help determine a standard approach for staple line reinforcement after laparoscopic sleeve gastrectomy. Additionally, should the location of the leak be consistent, this information may help drive technical changes that could decrease leak rate, an infrequent but potentially devastating risk of this and other weight loss surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing laparoscopic sleeve gastrectomy

Exclusion Criteria:

* Undergoing a revisional procedure
* Subject whose specimens need clinical attention by pathology following resection (e.g. cancer biopsy)
* Steroid use