cyrilzakka/clinical-trials huggingface dataset:
The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus

Open reduction and locking plate osteosynthesis is a commonly used and well-accepted treatment for displaced fractures of the proximal humerus. The shoulders tend to end stiff despite intensive rehabilitation, limiting the function of the upper extremity and decreasing the quality of life. The accepted postoperative mobilisation protocol includes passive exercises until six weeks postoperatively and active range of motion exercises after that. There is good evidence that conservatively treated fractures of the same site heal better and faster if mobilised immediately. The study compares "standard mobilisation" versus "immmediate mobilisation" in a prospective, randomized, controlled trial in order to find the optimal time-frame for physiotherapy to produce best possible results. Outcome measures are assessed at specific time points after the operation and comparisons between groups are made to follow the rate of recovery and end results.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Surgery can be performed within 10 days of injury
* A dislocated (\>1cm or 35 degrees) AO 11-A2, -A3, -B1 or -B2 fracture of the surgical neck of the proximal humerus with a possible fracture of the Tuberculum Majus

Exclusion Criteria:

* Glenohumeral dislocation
* Fracture of the Tuberculum Minus
* Open fracture
* Additional fractures in the shoulder region
* Other injuries requiring surgical treatment
* Clinically significant injury of the brachial plexus or vasculature
* Pathological fracture associated with cancer
* History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc)
* Rheumatoid Arthritis in the shoulder requiring active treatment
* Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc)
* Unwillingness to accept some of the treatment options.
Saizen in Intra-uterine Growth Retardation

Study of safety of Saizen® in children born with serious intra-uterine growth retardation (IUGR) treated to final height. An open, phase III study involving 17 centers in France.

The study enrolled children who have completed 3 or 2 years of treatment and at least one year of post treatment observation in the Sponsor Studies GF 4001 (Safety and Efficacy of Saizen in the Treatment of Young Children Born with Severe IUGR) or GF 6283 (Effect of Intermittent versus Continuous Saizen Therapy in Young Children Born with Severe IUGR), respectively.

Detailed description: Serious IUGR is a syndrome characterized by low birth length and weight for gestational age (less than 10 percentile). The secretion of growth hormone in response to provocative stimuli (e.g. arginine, insulin) is normal in these children. Apart from low birth weight, children born with IUGR may have minor or major malformations.

A catch-up period with a supraphysiological growth velocity generally occurs during the first 6 to 24 months of life in 80 to 90 percent (%) of these children. This generally allows them to reach normal height. That means that conversely, approximately 10 to 20% of children do maintain a statural handicap. Puberty occurs at a normal age and the retardation in bone maturation present during the first years of life disappears very quickly. This leads to short adult stature in subjects who have not shown spontaneous catch-up during the first years of life. A safe and effective means of promoting growth without accelerating the timing or tempo of puberty would therefore be desirable.


Eligibility Criteria:
Inclusion Criteria:

* Previous inclusion, good compliance and normal completion of GF4001 or GF6283 in the treatment of growth failure in children born with serious IUGR (3-year continuous r-hGH treatment in GF4001 or 2-year continuous or intermittent r-hGH treatment in GF6283).
* Increase in height greater than 0.5 standard deviation (SD) during the first 2 years of r-hGH treatment in GF4001 or after 2 years of continuous or intermittent r-hGH treatment in GF6283.
* A written Informed Consent at the beginning of the pre-study visit must be obtained from the parent(s)/legal guardian(s), with the understanding that consent may be withdrawn by the subject or parents at any time without prejudice to their future medical care. Children able to understand the trial should personally sign and date the written informed consent, too.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known multiple malformation syndrome with severe psychomotor retardation and/or body hemihypertrophy.
* Severe psychomotor retardation.
* Severe congenital malformations.
* Other protocol-defined exclusion criteria may apply.
A Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Severe Aplastic Anemia （SAA） Patient

This is a Multicentre, Open-label, single-arm, Phase II Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Severe Aplastic Anemia.

55 adult patients with SAA will be enrolled in the study. Treatment with Hetrombopag will be started at 7.5 mg/day and uptitrated according to the platelet count. The primary objective of the study is to assess the safety and efficacy of Hetrombopag in patients with SAA.


Eligibility Criteria:
Inclusion Criteria:

1. Previous diagnosis of refractory severe aplastic anemia, not meeting partial response criteria after at least one treatment course of immunosuppressive therapy, not suitable or unwilling to do hematopoietic stem cell transplantation.
2. Platelet count ≤ 30×109/L.
3. Signed informed consent.

Exclusion Criteria:

1. Bleeding and/or Infection not adequately responding to appropriate therapy.
2. Patients with a PNH clone size in neutrophils of ≥50%.
3. Treatment with immunosuppressive therapy within 6 months prior to study entry.
4. Any laboratory or clinical evidence for HIV infection. Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subjects screening.
5. ALT\> 2.5 x upper limit of normal (ULN), AST\> 2.5 x upper limit of normal (ULN) DBLI\> 1.5 x upper limit of normal (ULN), Scr\> upper limit of normal (ULN).
6. Subjects diagnosed with cirrhosis or portal hypertension.
7. Subjects diagnosed with tumor.
8. Patients with any prior history of congestive heart failure, arrhythmia, and peripheral arteriovenous thrombosis within 1 year. With a history of myocardial infarction or cerebral infarction within 3 months.
9. ECOG Performance Status of 3 or greater.
10. Female subjects who are nursing or pregnant within 6 months.
11. Subjects cannot take effective contraception.
12. Subjects have participated in other clinical trial within the 3 months prior to study entry.
The Pain in Intensive Care Unit: Different Rating System Comparing

The purpose of this research is to find the best system for assessing the pain of critically ill patient in Intensive Care Unit (ICU).

At first the investigators assess the sedation of the patient with the scale sedation-agitation scale (SAS) or the delirium with the confusion assessment method, if the patient is too sedated or delirious the investigators consider him unable to use the Visual Analogic Scale (VAS).

The investigators compare two different scales Critical Care Pain Observation Tool (CPOT) and Behavioural Pain Scale (BPS) which include no verbal items. Each items has been evaluated in three different moments: before, during and after the nurses' care.

The investigators compare the scales between them. Then, every time the investigators value the score of these scales with the self-report of patients with the VAS scale (when it is possible) and finally with the physiological parameters (blood pressure, heart rate and respiratory rate).

In the end, the investigators compare two different classes of patient: the surgical and medical one. The investigators search for some differences in the perception of the pain between these two classes.

This study has specific aims:

1. to find the best method to evaluate the pain in critically ill patients;
2. to compare the perception of pain analysed trough CPOT and BPS;
3. to compare CPOT and BPS between medical and surgical patients.

Eligibility Criteria:
Inclusion Criteria:

* male and female
* require of Mechanical Ventilation (MV)
* Hospitalization on ICU \> 24 hours

Exclusion Criteria:

* Age \< 18 years
* Tetraplegic
* Neuromuscolar disease
* Neuromuscolar blocking agents by continuous infusion
* Spontaneous breathing without Mechanical Ventilation (MV)
Alcohol and Bariatric Surgery

The investigators wish to study the effects of alcohol on three forms of bariatric surgery, Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG) and laparoscopic adjustable gastric banding (LAGB) and compare them with a non-surgical group. The surgery is not part of the clinical trial. If insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. The investigators are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on 1) alcohol absorption, distribution and elimination from the body, 2) the effects of alcohol on mood, and 3) the effects of alcohol on driving.

The study includes seven groups of women: One group will be undergoing RYGB another group will be undergoing LAGB, a third group will be undergoing SG, the fourth group will be women who underwent RYGB 1-5 years ago, the fifth group will be women who underwent LAGB 1-5 years ago, the sixth group will be women who underwent SG 1-5 years ago and the seventh group will be women who have equivalent age and body mass index than women in the groups who underwent RYGB or SG 1-5 years ago but did not have bariatric surgery (non-surgical group).

Eligibility Criteria:
Inclusion Criteria:

* Female
* Drink at least 1 standard alcoholic beverage/ month
* Underwent RYGB, SG, or LAGB 1-5 years ago or will undergo RYGB, SG, or LAGB surgery
* Did not undergo bariatric surgery (for the non-surgical group)

Exclusion Criteria:

* Male
* Smoker or quit \< 6 months ago
* Anemia
* Liver disease
* Body weight \> 450 pounds
* Taking medications that can interact with alcohol metabolism or the subjective effects of alcohol
Acupuncture in Persistent Atrial Fibrillation

The aim of this trial is to evaluate the effect of acupuncture on prevention of atrial fibrillation (AF) recurrence after electrical cardioversion (EC) for persistent AF patients resistant to the antiarrhythmic drugs (AADs).

This is a multicenter, prospective, participant and assessor blinded, randomized, sham-controlled clinical trial with 2 parallel arms. To evaluate the efficacy and safety of acupuncture, a total of 80 persistent AF participants will be recruited and randomly assigned to active acupuncture and sham acupuncture group. Both group commonly take antiarrhythmic medication during study period. These patients who are resistant to drug therapy will get a electrical cardioversion. After cardioversion, the recurrence rate and duration of atrial fibrillation free time will be evaluated.

This trial consists of 2 weeks of observation and medical therapy, 2 weeks of acupuncture intervention before EC, EC and acupuncture intervention, 7 weeks of additional intervention, and 5 weeks of follow-up. After randomization, participants receive 10 sessions of acupuncture treatments over 10 weeks. The outcome is assessed at 2, 4, 6, 8, and 16 week after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Persistent AF lasting ≥ 7 days
* Ages in 20-75 years
* Resistant with antiarrhythmic drugs
* Written informed consent

Exclusion Criteria:

* Age below 20 years or above 75 years
* Severe valvular heart disease
* History of open heart surgery
* History of treatment for myocardial infarction (MI) within recent 6 weeks
* Patients under or requiring the administration of antiviral drugs
* 2nd degree atrioventricular block or more than two fascicular block
* Severe pulmonary, liver, or renal disease
* Previous acupuncture treatment for cardiovascular condition within 3 months
Frontoparietal Priority Maps as Biomarkers for MTBI

The purpose of this study is to determine whether there is a quantitative relationship between brain processes seen by a MRI and visual deficits caused by mild to moderate traumatic brain injuries (mTBI).

Participants with mTBI, as well as healthy control participants, will be invited to participate in up to two study visits. Both visits will occur at the University of Minnesota's Center for Magnetic Resonance Research (CMRR). The first study visit will entail (1) interviews to determine the presence of (and, if present, the severity of) oculomotor difficulties such as convergence insufficiency, and (2) behavioral measures (e.g., visually track a moving dot) to assess skill at allocating spatial attention. For participants who have not before participated in an MRI study at the CMRR, a 15-minute scan to acquire research-quality anatomical images of the brain will be acquired at the end of the first visit. A subset of the approximately 88 participants who participate in Visit 1 will be invited to participate in Visit 2. Visit 2 will be dominated by a 90-minute scanning session in the 7 Tesla scanner, during which participants will perform a 10-minute spatial attention task and a 10-minute eye movement task, and high-resolution diffusion tensor imaging data will be acquired while participants enjoy the movie of their choice in the scanner.

Eligibility Criteria:
Inclusion Criteria:

* Normal or corrected to normal visual acuity
* No previously documented mTBI (target: 16 out of 88 participants invited for Visit 1)
* Previously documented mTBI (target: 72 out of 88 participants invited for Visit 1)
* Vision impairment (target: 48 out of 88 participants invited for Visit 1; expected to be comorbid with mTBI, but non-TBI participants with oculomotor impairments will not be excluded)

Exclusion Criteria:

* Current use of neuroactive drugs or medications
* Presence of neurological disorders (other than mTBI and mild PTSD)
* Contraindications for MRI (metal in the body, claustrophobia, diabetes or other diseases or drugs that affect thermoregulation)
* Inability to comply with behavioral task instructions
Effects of Intermittent Pneumatic Compression Following Exercise-induced Muscle Damaged

This study aims to assess the recovery kinetics following an exercise-induced muscle damage activity (using flywheel) on active healthy university students.

The main questions are:

- Is intermittent pneumatic compression superior to a placebo recovering from EIMD? Participants will perform a fatiguing protocol using flywheel and recover with either intermittent pneumatic compression or with a placebo treatment (micro-current treatment, but the device turned off). They will perform several performance tests before, following the recovery period, and at the 24h and 48h following the intervention


Eligibility Criteria:
Inclusion Criteria:

* To be eligible for participating in this study, participants should not have been recently injured, and should engage physical activity regularly (\>3 times/week).

Exclusion Criteria:

* Inactive participants
* Younger than 18 years old or older than 27 years old
PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1

This is a post-market, open observational long-term effectiveness follow-up study of participants with drug-resistant epilepsy with partial-onset seizures previously enrolled in a randomized controlled trial (PuLsE) comparing Best Medical Practice with or without adjunctive Vagus Nerve Stimulation Therapy.

In 2005 Cyberonics, Inc. initiated PuLsE: an open, prospective, randomized, parallel group study directly comparing Best Medical Practice with and without adjunctive VNS Therapy.

In July 2008, the decision was made to discontinue this study due to lower than expected enrolment, impairing the possibility to meet the primary objective with appropriate statistical power. However, the relatively large number of participants (n=121) randomized in the original PuLsE study offers the possibility to generate scientifically valuable and original findings if additional follow-up data can be gathered. After consultation with the PuLsE Investigators, Cyberonics decided to implement an observational long-term follow-up of the participants enrolled in the original PuLsE study.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for the study, the participant must meet all the following criteria:

1. Participant must have been randomized in the original PuLsE study.
2. Participant must have baseline data from the original PuLsE study.
3. Participant is able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance.
4. Participant or legal guardian understands study procedures and has voluntarily signed an informed consent for PuLsE 2 in accordance with institutional and local regulatory policies.

Exclusion Criteria:

The presence of any of the following will exclude a participant from the study:

1. Participant has a history of non-compliance with the completion of a seizure diary.
2. Participant currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
3. Participant is expected to require full body magnetic resonance imaging during the clinical study.
Day-night Rhythm in Muscle Metabolism of Prediabetics

This study evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism in prediabetic subjects. Subjects will stay at the research facility for 44 hours with a standardized living protocol during which several measurements of skeletal muscle and whole body energy metabolism will be performed.

Recent evidence from both observational and experimental studies indicates that disobedience of a normal day-night rhythm negatively influences metabolic and cardiovascular health, possibly leading to obesity and type 2 diabetes mellitus (T2DM). An important hallmark of obesity and T2DM is a decreased skeletal muscle mitochondrial function. Interestingly, recent research indicates that also skeletal muscle mitochondrial function is under the influence of a day-night rhythm. In this study, the presence of a day-night rhythm in skeletal muscle energy metabolism (in particular mitochondrial function) of overweight prediabetic participants will be investigated. During this study, subjects will stay at the research unit for 44 hours, with standardized meals and sleeping time. Five muscle biopsies (v. lateralis) and frequent blood draws will be taken. In addition, indirect calorimetry measurements will be performed.

Eligibility Criteria:
Inclusion criteria:

* Caucasian
* Healthy (as determined by dependent physician)
* Overweight: BMI 25 - 35 kg/m2
* Prediabetic based on one or a combination of the following criteria:

  * Impaired Glucose Tolerance (IGT): plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after glucose drink consumption during OGTT in screening.
  * Impaired Fasting Glucose (IFG): Fasting plasma glucose ≥ 6.1 mmol/l and ≤ 6.9 mmol/l.
  * Insulin Resistance: glucose clearance rate ≤ 360ml/kg/min, as determined using the OGIS120 model.
  * HbA1c of 5.7-6.4%.
* Regular sleeping time (normally 7 - 9h daily)
* Stable dietary habits: no weight gain or loss \> 3kg in the last three months.

Exclusion criteria:

* Use of anticoagulants
* Previously diagnosed with type 2 diabetes
* Current alcohol consumption \> 20 grams alcohol/day
* Extreme early bird or extreme night person (score ≤ 30 or ≥ 70 on MEQ-SA questionnaire)
* Heavily varying sleep-wake rhythm
* Nightshift work during last 3 months
* Travel across \> 1 time zone in the last 3 months
* Significant food allergies/intolerance (seriously hampering study meals)
* Using \> 400mg caffeine daily (more than 4 coffee or energy drink)
* Smoking
Effectiveness of the Pelican Instrument in Medical Care

The objective of this project is to establish the effectiveness of implementation of a self-administered electronic asthma-specific quality of life instrument for childhood asthma in primary care and specialist care.

Health related quality of life (HRQL) is important to the asthmatic child and if HRQL aspects are taken into account in daily care this could result in improved treatment satisfaction, compliance, asthma control and, ultimately, improved HRQL. The Pelican instrument we have developed has the essential features to be useful in daily care. In this study, the effectiveness of implementing the Pelican instrument in medical care is assessed. An intervention study with 9 months follow-up in primary and secondary care will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* age 6 to 12 years
* physician-diagnosed asthma
* use of bronchodilators and / or inhaled corticosteroids for at least six weeks during the previous year
* child is treated for its asthma by the recruiting physician
* signed informed consent by parent (or caretaker)
* child agrees to participate in the study

Exclusion Criteria:

* comorbid condition that significantly influences HRQL
* child does not master the Dutch language sufficiently
* not being able to attend a regular school class
A Study of PGN-EDO51 or Placebo in People With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment

The study consists of 3 periods: A Screening Period (up to 45 days), a double-blind, placebo-controlled Multiple Ascending Dose (MAD) Period (28 weeks), and a Long-Term Extension (LTE) Period (108 weeks).

The primary purpose of the MAD period is to evaluate the safety and tolerability and levels of dystrophin after multiple ascending intravenous (IV) doses of PGN-EDO51 administered to participants with Duchenne muscular dystrophy (DMD). During the MAD period, participants will be randomized to either receive PGN-EDO51 or placebo in a 3:1 fashion, meaning that participants have a 75% chance of receiving PGN-EDO51 and a 25% chance of receiving placebo during this period. The primary purpose of the open-label LTE period is to evaluate the long-term safety and tolerability of PGN-EDO51 in participants who have completed the MAD period. All participants who roll-over into the LTE will receive PGN-EDO51 (no placebo in the LTE).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of DMD with a genetic alteration that can be treated by skipping exon 51
* Body weight at least 25kg (55lbs)
* Performance of Upper Limb (PUL) 2.0 entry score of at least 4

Exclusion Criteria:

* Known history or presence of any clinically significant conditions that may interfere with study safety assessments
* Treatment with any gene replacement therapy for the treatment of DMD at any time
* Current or recent systemic infection within 2 weeks prior to Screening or infection requiring IV antibiotics within 4 weeks prior to Screening
* Recent surgery requiring anesthesia within 3 months prior to Screening or expected surgery requiring general anesthesia during the study
Handwriting Rehabilitation in Parkinson Disease

The aim of the study is to evaluate the efficacy of an intensive handwriting treatment in Parkinson's Disease.

The investigators aimed to understand whether an intensive handwriting treatment with cognitive engagement is more effective than a treatment exploiting only the passive wrist joint mobilization in Parkinson's Disease.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's Disease patients

Exclusion Criteria:

* Mini Mental State Examination (MMSE) score \< 24
* Left handed subjects
* Subjects with dyskinesias
* Subjects with Deep Brain Stimulation