cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet

• To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial atorvastatin tablets (Lipitor®).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
* Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication.
The ThinkCancer! Feasibility Study

Background Wales, like other UK countries, has relatively poor cancer outcomes. Late diagnosis and a slow referral process are major contributors. General practitioners (GPs) and other care providers working in primary care are often faced with patients presenting with a multitude of non-specific symptoms that could be cancer. Safety netting can be used to manage diagnostic uncertainty by ensuring patients with vague symptoms are appropriately monitored. The ThinkCancer! Workshop is an educational behaviour change intervention aimed at the whole general medical practice team, designed to improve primary care approaches to ensure timely diagnosis of cancer. The workshop will consist of teaching and awareness sessions, appointment of a Safety Netting Champion and the development of a bespoke Safety Netting Plan. This study aims to assess the feasibility of the ThinkCancer! Intervention for a future definitive randomised controlled trial, in terms of recruitment, randomisation, retention, acceptability, adherence and barriers to the intervention.

Methods The ThinkCancer! study is a randomised, multisite feasibility trial, with an embedded process evaluation and economic evaluation. Twenty-three to 30 general medical practices will be recruited across Wales, randomised in a ratio of 2:1 of intervention versus control who will follow usual care. The workshop will be delivered by a GP educator, and will be adapted iteratively throughout the trial period. Baseline practice characteristics will be collected via questionnaire. We will also collect Primary Care Interval (PCI), Two Week Wait (2WW) referral rate, conversion rate and detection rate at baseline and six months post-randomisation. Participant feedback, researcher reflective notes and economic costings will be collected following each workshop. A process evaluation will assess implementation using an adapted Normalisation Measure Development (NoMAD) questionnaire and qualitative interviews. An economic feasibility analysis will inform a future economic evaluation.

Discussion This study will allow us to test and further develop a novel evidenced-based complex intervention aimed at general practice teams to expedite the diagnosis of cancer in primary care. The results from this feasibility study will inform the future design of a full-scale definitive phase III trial.


Eligibility Criteria:
Inclusion Criteria:

* Any practices in Wales are eligible for inclusion.

Exclusion Criteria:

* As we intend to include a broad group of general medical practices, there are no formal exclusion criteria.

As determining feasibility is the main objective of this study, the eligibility criteria remain broad in order to allow for inclusion of a range of practices, which will aid the intervention refinement and allow for a better understanding on what is feasible in all types of practices and why some practices may not take part.
Evaluation of Physical Therapy Interventions and Patient Characteristics on Outcomes

Data collection for this study will be done by clinicians working in inpatient rehabilitation units with persons with acute stroke. No interventions are included in this study. It is designed to capture trends in current clinical practice for persons with stroke. This data will be useful in identifying the most beneficial and effective walking treatments as well as most significant patient characteristics that impact recovery for persons acutely after stroke. All data collection will take place during the inpatient rehabilitation stay.

All persons admitted to the inpatient rehabilitation unit will be screened for inclusion. Only those with a confirmed diagnosis of stroke (CVA) will be included. Data collection on the participants will begin at the time of admission and continue through discharge. Average length of stay for persons with stroke in inpatient rehabilitation units is 21 days. Some persons will stay fewer days and some will stay longer. Data collection will include key information on physical therapy interventions including gait training, balance training, group therapy, manual therapy, exercise, transfer training, stairs, family training, wheelchair training, modalities, discharge planning, seated and supine exercises. Other data will be collected including tone, motor control, sensation, gait endurance, falls, wounds, restraints, deep vein thrombosis, tracheostomy, feeding tubes and blood pressure. Additional data collection will include age, gender, race, length of time post stroke, time in rehabilitation, Functional Independence Measure scores, case mix group, discharge destination. In addition, physician history and physical as well as discharge summary will be collected, as will evaluation and discharge notes from therapies (physical, occupation, speech, social work). Patients will not be responsible for any costs associated with this data collection.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with a confirmed primary diagnosis of stroke, within 6 weeks of onset, will be included.
* Persons will be between the ages of 16 and 80.
* Persons may have experienced a previous CVA if they experienced a full gait recovery.

Exclusion Criteria:

* Any patient with a history of stroke onset greater than 6 weeks prior to admission will not be included.
* In addition, persons with bilateral CVA will not be included as well as persons who were not ambulatory prior to the CVA.
Magnesium for Shivering in Epidural Lidocaine Deliveries

Magnesium has been shown to decrease the shivering experienced from neuraxial anesthesia. This study aims to investigate whether magnesium decreases the shivering experienced in parturients undergoing labor epidural anesthesia for Cesarean delivery.

Women who have epidurals in place and go on to require a Cesarean delivery typically have their epidurals 'topped-up' with a fast onset local anesthetic to ensure the lower body is fully numb for surgery. This is called an epidural 'top-up'. However, a side effect of epidural top-ups is shivering, which is uncomfortable for the mother and interferes with patient monitoring. Magnesium administration has been shown to decrease shivering in the non-pregnant population. Therefore, in this study the investigators aim to determine if magnesium given prior to an epidural top-up decreases the incidence and severity of shivering in the pregnant population.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age of ≥37 weeks
2. Women who are ≥ 19 years old
3. Women undergoing Cesarean delivery under lidocaine top-up via a preexisting epidural catheter inserted for labor analgesia
4. American Society of Anesthesiologist (ASA) Physical Status class 1 or 2

Exclusion Criteria:

1. Emergency Cesarean delivery with limited time for informed consent
2. Women who have received MgSO4 prior to study enrollment
3. Indication for alternative mode of anesthesia for Cesarean delivery (e.g., general anesthesia)
4. Medical conditions or medications that could lead to tremor or shivering. (e.g., movement disorder, untreated thyroid disease) or mask tremor or shivering (e.g., beta-blocker, benzodiazepine, anticonvulsants)
5. Active shivering at time of recruitment
6. Inability to read and understand English for the purpose of informed consent
7. Contraindications to receiving MgSO4 (hypersensitivity reactions, respiratory rate \<16breaths/min, absent reflexes, urine output \<100 mL during the previous 4 hours, renal failure, or hypocalcemia)
8. History of previous postpartum hemorrhage
Body Movement Imitation and Perspective Perception Among Psychiatric Patients

The ability to understand the other's perspective and respond accordingly is the most important normal process of daily social life and is probably one of the foundations of human existence. This capability is reflected, inter alia, as an imitation - an important and effective form of learning which is very developed in humans. When we are required to imitate a particular movement, speed of response depends on the perspective of the movement. Imitative response is implemented faster when the movement is observed from first-person perspective, than if the motion is presented from the perspective of a third party.

While healthy individuals don't find it difficult to imitate, or to understand the other's emotion expression, there are psychiatric populations (such as autism and schizophrenia) who find it difficult to demonstrate these capabilities (Park, Matthews et al. 2008). Beyond these capabilities impairment, schizophrenic patients have difficulty distinguishing between their arm movements and those of a foreign hand and find it difficult to leave the boundaries of egocentric interpretation of reality and adopt the other's point of view. These behavioral disorders arise from defects in the network of mirror neurons (Buccino and Amore 2008; Langdon, Coltheart et al. 2010).

Therefore, the investigator expect that schizophrenic patients will not see a preference for movements that will be displayed in first-person perspective from the same movements that will be displayed from the perspective of a third party. Consequently, the investigator speculate that these subjects will not exhibit differences at imitating the response of which will be presented from different perspectives (Jackson, Meltzoff et (al. 2006.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 20-65.
2. Subjects who met the criteria for diagnosis of major DSM-IV for schizophrenia or unipolar depression.
3. Subjects with normal or corrected vision.
4. Subjects who sign informed consent for their participation in the experiment

Exclusion Criteria:

1. Patients with acute disorder, or an unstable patient. Especially neurological disorders or head injuries.
2. Drug Abuse in the past year.
3. Lack of jurisdiction, such as people with mental retardation or dementia.
4. assessed with high suicide risk.
5. patients which are Compulsory hospitalized.
6. Pregnant women
Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults With ADHD

To evaluate clinical effectiveness of medication treatment for ADHD. It is hypothesized that the effectiveness is lower than efficacy outcomes measured in clinical trials

This is a prospective, long-term, observational study of routine clinical care. The study measurements will be integrated into the clinical assessment and follow-up procedures of the outpatient services under the Provincial ADHD Program. The study is designed for systematic follow-up of children and adolescents, diagnosed with ADHD irrespective of comorbidity or whether they elect to receive medication treatment. Evaluations occur every 6 months for 24 months. The population to be examined is children and adolescents with a diagnosis of ADHD, aged 6 to 18 inclusive (at baseline), referred to the Provincial ADHD Program for clinical assessment. No studies have been conducted that have evaluated the outcome of core ADHD symptoms in a clinic setting. Metaanalysis of clinical trials of medication treatment for ADHD have suggested an effect size of approximately 0.8. Because of the heterogeneity of the clinic sample, a much lower effect size can be anticipated. Two hundred patients will be enrolled in this study with primary measure of effectiveness being change in ADHD symptoms.

Eligibility Criteria:
Inclusion Criteria:

Meet DSM-IV criteria for ADHD

Exclusion Criteria:

None
Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation

The purpose of this study is to compare the exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and quality of life. However, optimal SpO2 value during pulmonary rehabilitation in patients with chronic respiratory failure receiving long-term oxygen therapy is unclear.

The present study is randomized to compare the effect of exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months.

Exclusion Criteria:

* Subjects with severe cardiovascular disease, liver disease, neurological disease, and renal failure.
* Subjects with a history of hospitalization for pneumonia or exacerbation of respiratory failure within the last month.
* Subjects with changes in LTOT prescription flow within the last month
* Subjects who cannot undergo pulmonary rehabilitation due to severe heart failure, arteriosclerosis obliterans or spinal disease.
An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)

To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is generally safe and well tolerated in the Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Subject Is Female, Between The Ages Of 9 Years And 0 Days And 26 Years And 364 Days On The Day Of Enrollment
* Subject (Or, For Minor Subjects, Parent/Legal Guardian And Subject) Fully Understands Study Procedures, Alternative Treatments Available, The Risks Involved With The Study, And Voluntarily Agrees To Participate By Giving Written Informed Consent
* Subject Is Able To Read, Understand, And Complete The Vaccination Report Card

Exclusion Criteria:

* Subject Is, At The Time Of Signing Informed Consent, A User Of Recreational Or Illicit Drugs Or Has Had A Recent History (Within The Last Year) Of Drug Or Alcohol Abuse Or Dependence. Alcohol Abusers Are Defined As Those Who Drink Despite Recurrent Social, Interpersonal, And/Or Legal Problems As A Result Of Alcohol Use
* Subject Has A History Of Severe Allergic Reaction (E.G., Swelling Of The Mouth And Throat, Difficulty Breathing, Hypotension Or Shock) That Required Medical Intervention
* Subject Has Known Allergy To Any Vaccine Component, Including Aluminum, Yeast, Or Benzonase (Nuclease, Nycomed \[Used To Remove Residual Nucleic Acids From This And Other Vaccines\])
A Trial Investigating the Pharmacokinetic (Mode of Action in the Body) and Safety Profiles of NN1250 (Insulin Degludec) in Subjects With Various Degrees of Impaired Liver Function and in Subjects With Normal Liver Function

This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects with impaired liver function compared to the dose for subjects with normal liver function.


Eligibility Criteria:
Inclusion Criteria:

* Subject with normal hepatic function, liver parameters within normal range. Not assessed with the Child-Pugh criteria. Or: Subject with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by Investigator
* Body mass index maximum 40.0 kg/m\^2

Exclusion Criteria:

* Subject with any disease or condition which the Investigator feels would interfere with the trial outcome or execution except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Not able or willing to refrain from smoking during the inpatient period
Treatment of Obsessive-Compulsive Disorder

The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics).

There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.

To advance the neurobiology and treatment of obsessive-compulsive disorder (OCD) by focusing on Tourette's Syndrome (TS)-spectrum OCD as a possible homogeneous form of OCD, and investigating the relevance of intact 5-hydroxytryptamine (5-HT) function to the mechanism of anti-OC drug action. The validity of TS-spectrum OCD as a distinct subtype is assessed using a detailed clinical, family, drug treatment response profile in adult OCD patients.

In Study I, patients are divided prospectively into 2 putative subtypes (TS-spectrum and non-TS-spectrum OCD) on the basis of clinical history and direct, structured interviews of family members (approximately 400 interviews).

In Study II, patients enter an 8-week single-blind trial with the potent and selective 5-HT reuptake inhibitor fluoxetine (FX). Patients with an incomplete response to FX alone (approximately 64 patients) are randomized to a 4-week double-blind trial of FX in combination with the dopamine (DA) 2 antagonist olanzapine (OLA) or placebo (PLA).

Eligibility Criteria:
Inclusion criteria required that subjects, ages 14-70 years, have at least a 1-year duration of a current Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) principal diagnosis of OCD. Furthermore, the OCD had to be defined by a rating of "moderate" or greater on the global severity item of the Clinical Global Impressions (CGI) scale and have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 19 or greater.

Exclusion criteria included primary depression, schizophrenia, or other psychotic disorders; active bipolar disorder; abuse of alcohol or other significant substance within 6 months; increased risk of seizures or history of neurosurgery, encephalitis, or significant head trauma; or a significant medical condition, such as heart, liver, or renal disease. Subjects with an intelligence quotient of less than 80 as determined with the Kaufman Brief Intelligence Test (Kaufman and Kaufman 1990) were excluded.
Subtalar Extra-articular Screw Arthroereisis

The aim of the study is to investigate the effect of subtalar extra-articular calcaneo-stop screw on the proprioceptive and nociceptive pathways of the ankle before and after implantation. The hypothesis of the study is that an increased number of receptors related to proprioception will be detected in the sinus tarsi.


Eligibility Criteria:
Inclusion Criteria:

Study Group:

* Patients aged 14 years old and above that will remove the calcaneo stop screw, in place for at least 3 years after the implant, will be recruited
* Patients willing and able to give informed consent for the participation in the study. For underage patients, a parent/legal representative will give consent for the participation in the study.
* Male and female patients in fertile age can be recruited.

Control Group:

* Syndromic patients
* Previous foot malformation (synostosis, congenital clubfoot)
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.

Exclusion Criteria:

Control Group:

* Syndromic patients
* Previous foot malformation (synostosis, congenital clubfoot)
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.

Study Group:

* Patients suffering from post-operative complications
* Syndromic patients
* Previous foot malformation (synostosis, congenital clubfoot)
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines

NT 201 is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, NT 201 causes local weakening to full paralysis depending on the administered dose. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study will determine the optimal dose of NT 201 in the treatment of glabellar frown lines.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe glabellar frown lines

Exclusion Criteria:

* Previous insertion of permanent material in the glabellar area
* Neuromuscular function disease
The Use of X-ray in Bariatric Surgeries

examination of the importance of the use of X-ray in bariatric surgery outcome.

the x-ray will be used in order to evaluate the number of complications occured during bariatric surgeries such as bleeding, leak, etc. a retrospective analysis of patients with those complications will be performed and the presence of the x-ray and its findings will also be documented.

Eligibility Criteria:
Inclusion Criteria:

first bariatric surgery

Exclusion Criteria:

recurrent bariatric surgery
Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.

Oral iron supplementation is often associated with rapid onset of gastrointestinal side-effects. The aim of this study was to develop and trial a short, simple questionnaire to capture these early side-effects and to determine which symptoms are more discriminating.

The study was a double-blind placebo-controlled randomized parallel trial with one week treatment followed by one week wash-out. Subjects were randomized into two treatment groups (n=10/group) to receive either ferrous sulphate (200 mg capsules containing 65 mg of iron) or placebo, both to be taken at mealtimes twice daily during the treatment period. Subjects completed the questionnaires daily for 14 days. The questionnaire included gastrointestinal symptoms commonly reported to be associated with the oral intake of ferrous iron salts (i.e. nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation).


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy subjects.

Exclusion Criteria:

* The presence of any chronic disease, pregnancy or lactation were considered as exclusion criteria.