cyrilzakka/clinical-trials huggingface dataset:
Proprioceptive Isokinetic Repositioning, Functional Testing, and a Self-reported Questionnaire Before and After Anterior Cruciate Ligament Reconstruction

This prospectively study aims to evaluate the evolution of knee joint proprioception on isokinetic dynamometer before and after Anterior Cruciate Ligament (ACL) reconstruction and its relationships with muscle strength, self reported questionnaire and return to sport. This study will include 30 athletes with isolated ACL rupture, and treated with ACL reconstruction surgery and 15 healthy volunteers.

Anterior cruciate ligament (ACL) rupture is a common injury in athletes. It has multiple consequences on the knee: instability, pain, loss of muscle strength, proprioceptive impairments, modification of the knee kinematics and premature knee osteoarthritis. In athletes, the majority of these injuries are treated with ACL reconstruction surgery. The main objective of this treatment is the reduction of knee instability to allow return to sport, and this at the same level prior to the injury. Thus, the athlete's follow-up after the surgery is essential to guide the return to sport and to ensure that the knee sensorimotor control allows the return to sport. Currently this assessment is based primarily on functional testings and measurement of muscle strength.

The investigators propose to prospectively study the evolution of instrumentally measured knee proprioception using isokinetic dynamometer before and after ACL reconstruction as well as a study of the factors associated with its favorable evolution and its impact in the return to sport and its level.

Eligibility Criteria:
Inclusion Criteria:

* Isolated and primary tear of the ACL
* Individual candidate for an ACL reconstruction surgery.
* Acute ACL injury (\<6 weeks)
* Athletes (person who competes in one or more sports that involve physical strength, speed or endurance) whatever their level of sport practice
* Internet access

Exclusion Criteria:

* Prior knee surgery
* Complex ligamentous lesion (lateral ligaments, posterior cruciate ligament)
* Surgery for meniscal lesions (patients initially included but warranting meniscal surgery during arthroscopy will be secondarily excluded from the study.)
* Recent muscle damage
* History of significant injury on the healthy knee
* ACL rupture recurrence
* Pregnant woman
* Neurological or vestibular antecedent with sequelae
* Individuals taking treatment altering alertness (neuroleptics, sedatives)
* Informed consent not obtained
Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to compare the efficacy of rabeprazole extended release (ER) 50 mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in subjects with healed erosive gastroesophageal reflux disease (eGERD).

This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups, RAB ER 50 mg (once daily) or Ranitidine 150 mg (twice daily).

Eligibility Criteria:
Inclusion Criteria:

1. Prior completion of Study E3810-G000-301 or -303. Subjects will need to have healed erosive esophagitis (absence of esophageal mucosal breaks or erosions) confirmed by EGD and sustained resolution of heartburn at Visit 4 or 5 of Study E3810-G000-301 or -303.

Exclusion Criteria:

1. Esophageal motility disorders (achalasia, scleroderma, or esophageal spasm).
2. Barrett's esophagus or esophageal stricture.
3. Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine receptor antagonists (H2RA), antacids, sucralfate, misoprostol, prokinetics or drugs with significant anticholinergic effects throughout the study.
4. Subjects who require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (\>= 20 mg/day prednisone or equivalent), or aspirin (-\>; 325 mg/day).
5. Significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities that would be likely to interfere with the conduct of the study, the interpretation of study results, or the health of the subject during the study.
6. Any condition that would make the subject, in the opinion of the investigator or sponsor, unsuitable for the study.
FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients

The FeelFit study aims to assess the effectiveness of High-Intensity Interval Training (HIIT) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. Furthermore, several secondary and exploratory outcomes will be evaluated. The study is part of the GRIP (GuaRding quality survivorshiP) project, which aims to improve quality of life in brain tumor patients.


Eligibility Criteria:
Inclusion Criteria:

* reduced self-reported physical fitness;
* minimum age of 18 years;
* diagnosed with a primary brain tumor;
* stable disease, i.e. no signs of radiological or clinical tumor progression;
* no oncological treatment for at least two months prior to inclusion;
* able to speak, read and write in Dutch.

Exclusion Criteria:

* Karnofsky Performance Score \< 70;
* already participated in a HIIT program \< 1 month prior;
* contraindication of exercise.
French Registry of Children Treated With Norditropin® for Short Stature Associated With Noonan Syndrome

This is a non-interventional registry of children treated with Norditropin® for short stature due to Noonan Syndrome (NS). This study aims to provide data on long-term growth evolution and safety of Norditropin® as well as Health Related Quality of Life (HRQoL) data. This registry will include the entirety of children treated with Norditropin® for short stature due to NS over the inclusion period. The decision to initiate treatment with commercially available Norditropin® is made by the patient/parents/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical and/or genetic diagnosis of NS
* Patients who are treated with Norditropin® (already treated or initiating) and who are followed in a participating center
* The decision to initiate treatment with commercially available Norditropin® has been made by the patient/parents/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study

Exclusion Criteria:

* Patients/Parents/LAR opposed to the collection and processing of their children's medical data
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
The Effects of Wearing a Face Mask During Exercise in Youth Hockey Players During COVID-19

There is concern that wearing a face mask during COVID will affect oxygen uptake, especially during intense exercise. COVID transmission is especially prevalent in sports such as hockey, where there is close contact between players and arena ventilation is poor. This study will assess the effect of wearing a surgical face mask on simulated hockey performance and blood and muscle oxygenation during cycling exercise.

The sport of ice hockey involves close contact between players in poorly ventilated arenas. This increases susceptibility for transmission of viruses, such as COVID-19. Face masks can reduce the risk of virus transmission; however, there is concern that wearing a face mask during exercise will reduce oxygen uptake or increase carbon dioxide re-breathing, which can result in low blood oxygen levels, reduced oxygen delivery to muscle and reduced exercise capacity. The purpose of the study is to determine the effect of wearing a surgical face mask during exercise that simulates ice hockey play on exercise performance and blood and muscle oxygenation in boys and girls. Twelve boys and twelve girls (age 9-14y) who are experienced playing hockey, will take part in this randomized cross-over study that will assess exercise performance, blood oxygenation (i.e. pulse oximetry) and muscle oxygenation (with near infrared spectroscopy) during an exercise test on a cycle ergometer with workloads and work to rest intervals that simulates hockey performance. Participants will also be tested for repeated-sprint performance on ice while wearing full hockey equipment. The conditions include no mask (a "sham" mask) and a surgical mask. Outcome variables include power output during the cycle ergometer testing, skating distance during the on-ice test, rating of perceived exertion, blood oxygen saturation levels, and oxygenated, deoxygenated, and total hemoglobin at the quadriceps muscle.

Eligibility Criteria:
Inclusion Criteria:

* Experience playing ice-hockey

Exclusion Criteria:

* Contra-indications to exercise as identified by a screening questionnaire (the "Get Active Questionnaire")
Feasibility and Safety of In-bed Cycling/Stepping in Critically Ill Patients

Intensive care unit (ICU)-acquired weakness (ICU-AW) is one of the most common complications of post-ICU syndrome. It is the leading cause of gait disturbance, decreased activities of daily living, and poor health-related quality of life. The early rehabilitation of critically ill patients can reduce the ICU-AW. We designed a protocol to investigate the feasibility and safety of conventional rehabilitation with additional in-bed cycling/stepping in critically ill patients. The study is designed as a single-center, open-label, pilot, randomized, parallel-group study. After the screening, participants are randomly allocated to two groups, stratified by mechanical ventilation status. The intervention group will be provided with exercises of in-bed cycling/stepping according to the level of consciousness, motor power, and function in addition to conventional rehabilitation. In contrast, the control group will be provided with only conventional rehabilitation. The length of the intervention is from ICU admission to discharge, and interventions will be conducted for 20 minutes, a maximum of three times per session. The primary outcome is the number and percentage of completed in-bed cycling/stepping sessions, the duration and percentage of in-bed cycling/stepping sessions, and the number of cessations of in-bed cycling/stepping sessions. The secondary outcomes are the interval from ICU admission to the first session of in-bed cycling/stepping, the number and percentage of completed conventional rehabilitation sessions, the duration and percentage of conventional rehabilitation sessions, the number of cessations of conventional rehabilitation sessions, the number of adverse events, level of consciousness, functional mobility, muscle strength, activities of daily living, and quality of life. This study is a pilot clinical trial to investigate the feasibility and safety of conventional rehabilitation with additional in-bed cycling/stepping in critically ill patients. If the expected results are achieved in this study, the methods of ICU rehabilitation will be enriched.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 45
* Admission to ICU ≤ 72 hours
* Patient deemed to need ≥ 48 hours of ICU care
* Premorbid functional ambulation category≥ 2

Exclusion Criteria:

* Neurologic disorders i.Central nervous system: acute stroke, advanced dementia, hypoxic-ischemic encephalopathy ii. Peripheral nervous system: amyotrophic lateral sclerosis, myasthenia gravis, acute inflammatory demyelinating polyneuropathy
* Acute deep venous thrombosis, pulmonary embolism
* Pneumothorax
* External fixator, superficial metallic implants, amputation, eschar, etc
* Expected ICU discharge within 3 days of admission
* Pregnant
* Difficulty in obtaining consent (rejection, no family, if the family does not agree)
* If the life expectancy is less than 6 months
Use of Airtime Timing to Improve Interactive Voice Response Surveys in Bangladesh and Uganda

This study evaluates the effect of two different airtime incentive timings on interactive voice response (IVR) survey cooperation, response, refusal and contact rates, as compared to a control group, in Bangladesh and Uganda.

Using random digit dialing sampling techniques, the study randomized RDD participants to one of three airtime incentive timings, some of all of that incentive being contingent on their completing the noncommunicable disease risk factor survey. This mobile phone survey was sent as an interactive voice response (IVR). In IVR surveys, participants use their touch tone key pad to answer pre-recorded questions. (i.e. If you are male, press 1; if you are female, press 2). This study was conducted in both Bangladesh and Uganda.

Eligibility Criteria:
Inclusion Criteria:

* Access to a mobile phone
* Greater or equal to 18 years of age
* In Bangladesh, conversant in either English or Bangla language. In Uganda, conversant in either Luo, Luganda, Runyakitara, or English languages.

Exclusion Criteria:

* Less than 18 years of age
A Multicenter Prospective Cohort Study on the Clinical Prognosis of Ulcerative Colitis

Mucosal healing or histological remission is an important target for the treatment of inflammatory bowel disease. In this study, patients with mucosal healing are defined as a control group, observing their clinical outcomes for 3 years, and describing the recurrence rate. The secondary objective is to study the operative rate, glucocorticoid utilization rate, treatment escalation rate, hospitalization rate and incidence of related complications.

Assess the health condition of patients for 1year, 2year,3year and analyze outcomes and complications.

Eligibility Criteria:
Inclusion Criteria:

* sign informed consent before proceeding with any specific procedure.
* ages:14-75
* subjects were diagnosed with ulcerative colitis in written form. (written diagnosis should include at least one histopathological change).
* mucosal healing or histological remission has been achieved after medical treatment.

  1. histological assessment is performed by 2 pathologists independently, and endoscopy have been independently evaluated by two endoscopic doctors.
  2. prospective cohort study (3) definition of endoscopic mucosal healing: Baron score\<=1 and Mayo score\<=1 (4) definition of histological remission: Truelove/ Richards=1 and Geboes score\<3.0 (5) sampling methods: the terminal ileum, the ascending colon, the transverse colon, the descending colon, the sigmoid colon, and the rectum, the six parts were randomly taken specimen (at least 2 tissues each).
* data integrity: the research data include: 1) enteroscopy; 2) laboratory examination indicators: blood routine, erythrocyte sedimentation rate, C reaction protein, liver function, renal function, fecal calprotectin, 3) serum concentration of infliximab, antibody to infliximab.
* subjects were treated with the following treatment Mesalazine, glucocorticoid, immunosuppressive agent (azathioprine or thalidomide), biologics (infliximab) 7. subjects have the ability to answer the questionnaire

Exclusion Criteria:

* The diagnosis is unclear
* Subjects with history of colectomy
* Subjects with history of cancerogenesis
* Subjects with severe liver disease, defined as child-pugh Grade B or Grade C
* Subjects with severe renal disease, defined as Estimated glomerular filtration rate\<30
* major cardiovascular events, such as stroke, myocardial infarction, or unstable angina, occurred within 3 months before enrollment.
* Subjects during pregnancy.
* alcohol or drug abuse
* poor compliance 10 Planners and investors
Iron Supplement Effect on Child Development

Objective: To evaluate the effect of Iron supplement with two different amounts (one in the higher limit and another in the lower limit of the suggested amount) according to the presence of mutations in the HFE gene in the physical, immune and neurobehavioral development in the 6 to 12 moth toddlers.

Methodology: Subjects: 340 toddlers coming from Paediatric Serves of Sant Joan Hospital. Methods: At 6 and 12 months it done clinical history, food registry, biochemist determinations: haemoglobin, iron, transferrin, ferritin, reactive C protein and immune response (IL4, IL10, IL6 IFN, IgA, IgM, IgG, IgE). Mutations in the HFE gene: C282Y, H63D, S65D and hepcidin gene. Mental, psychomotor and behavioual development (Bayley Scales of Infant Development 2on Edition: 1993). We evaluate the level of language and communication (MacArthur), regulation and sensory process (Infant Toddler Symptom Checklist), familiar and environment surroundings (Scale Health General Parental Stress Index).

Design: Randomised Clinical Trial with two groups of intervention. Group A received high-iron fortified milk (1.2mg/100mL) and Group B received low-iron fortified milk (0.4mg/100mL).

Inclusion criteria: caucasian new-borns, term infants.

Exclusion criteria:

* Families that refuse enter at the follow-up.
* Low-birth weight or preterm infants.
* Anaemic infants.
* Infants with congenital defects, immunodeficiency or hypothyroidism.
* Infants with diseases that requires intensive care.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian infants
* Healthy term infants

Exclusion Criteria:

* Families that do not understand Spanish or Catalan
* Anaemic infants at birth
* Infants with important diseases
Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer

This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches. This study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT), with chemotherapy. All subjects on this study will be treated with gemcitabine. This chemotherapy agent has been used for patients with pancreatic cancer. The researchers have already done studies using radiation therapy and gemcitabine. They want to build on the information they have from this previous research. The researchers want to find the best dose of IMRT that can be given at the same time that patients are receiving gemcitabine. To do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. The goal of the research is to identify the highest dose of IMRT that can be given at the same time as the chemotherapy without causing severe side effects.


Eligibility Criteria:
Inclusion Criteria:

* Is the patient 18 years of age or older.
* Does the patient have histologically or cytologically proven carcinoma of the pancreas
* Is the tumor unresectable or medically inoperable
* Does the patient have a Zubrod performance status of ≤ 2 (appendix I).
* Does the patient have an absolute neutrophil count of ≥ 1500/mm3, and platelets ≥ 100,000/mm3
* Does the patient have adequate renal function (creatinine \< 2 mg/dl) and hepatic function (bilirubin \< 3 mg/dl), with relief of biliary obstruction if present
* Is the patient free of significant co-morbid conditions that would preclude safe administration or completion of protocol therapy
* If the patient is of reproductive potential, has he or she agreed to use an effective method of contraception during treatment on this trial and for 6 months after treatment
* Is the patient aware of the investigational nature of the therapy such that they can provide written informed consent

Exclusion Criteria:

* Does the patient have a neuroendocrine tumor of the pancreas
* Does the patient have metastatic disease
* Does the patient have a history of abdominal radiation therapy
* Is there history of more than 1 month of therapy with single agent gemcitabine
* Has the patient used any investigational agent in the month before enrollment into the study
Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

The purpose of this study was to evaluate whether 2 puffs of fixed combination of aerosolized 120 mcg salbutamol sulphate (equivalent to 100 mcg of the base) + 20 mcg ipratropium bromide confers significant additional protection against metacholine induced bronchoconstriction in asthmatic atopic patients when compared to 2 puffs of aerosolized 100 mcg salbutamol alone.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with a diagnosis of asthma according to the American Thoracic Society Criteria
* Patients aged 7 to 12 years inclusive
* Patients able to perform spirometry
* Patients with FEV1 (forced expiratory volume in the first second) ≥ 80% of predicted normal value after saline
* Patients with PD20 (provocative dose that reduces FEV1 by 20 %) metacholine lower than 8 mg/ml
* Patients or responsible relatives willing and able to sign an informed consent form

Exclusion Criteria:

* Patients on treatment for or suspected as having glaucoma
* Patients with known allergy of contra-indications to either salbutamol, ipratropium or their excipients
* Patients suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum
* Patients with a history of chest surgery
* Patients with other respiratory conditions if diagnosed. These include pulmonary fibrosis, bronchiectasis, cystic fibrosis, sarcoidosis, pulmonary tuberculosis, pulmonary complications of AIDS
* Patients requiring drugs for the treatment of the acute asthma attack other than the study drugs or oxygen
* Patients who have been previously recruited into this study
* Patients with myocardiopathy, pulmonary edema or other life threatening diseases, which in the judgement of the pediatrician precludes their entry into the study
* Patients with obvious or previously diagnosed serious hepatic or renal disease
* Patients who have been under the following drugs within the specified periods of time prior to determination of Baseline FEV1 or metacholine challenge

  * INHALED:
  * Short acting β2 agonists: 6 hours
  * Long acting β2 agonists: 12 hours
  * Ipratropium bromide: 8 hours
  * DSCG (disodium cromoglicate): 7 days
  * Nedocromil: 7 days
  * ORAL:
  * Short acting β2 agonists: 18 hours
  * Anticholinergics: 7 days
  * Short acting theophylline: 24 hours
  * Long acting theophylline: 72 hours
  * Antihistamines: 7 days
  * Astemizole: 3 months
  * Ketotifen: 3 months
  * INHALED or ORAL: Other investigational drugs: 3 months
  * INHALED or ORAL: Corticosteroids: 30 days