cyrilzakka/clinical-trials huggingface dataset:
Comparative Evaluation of Functional Results and Survival Rate of Peroneus Longus Tendon - PLT and Hamstring Tendon - HT Used for Reconstruction of the Anterior Cruciate Ligament.

Comparative evaluation of functional results and survival rate of peroneus longus tendon - PLT and hamstring tendon - HT used for reconstruction of the anterior cruciate ligament.

Comparison of treatment results - survival and reconstruction of autographs and functional results of the knee joint, and functional results of the ankle joint, obtained in the study groups operated using two methods:

A- the use of a long fibular tendon autograft taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint; B- the use of Hamstring muscle tendon autograft (Semitendonus and slender muscle) taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years;
* Surgery for ACL damage to the knee joint;
* Arthroscopic surgery;
* No prior knee surgical interventions;
* No additional pathologies in this anatomical area;
* Patient informed consent to participate in research.

Exclusion Criteria:

* Age under 18 or over 65;
* Previous surgical interventions in the examined anatomical area;
* Additional pathologies in this area identified as part of preoperative diagnostics;
* Damage to the second knee joint;
* Failure to comply with the rigor of the same rehabilitation treatment protocol.
Enteral Formula Tolerance of Standard Tube Feedings

This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Currently tolerating enteral feeding
* Has enteral access
* Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 21 days
* Having obtained his/her and/or his/her legal representative's informed consent.

Exclusion Criteria:

* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
* Lack of enteral access
* Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)
* Currently participating in another conflicting clinical study that would interfere with anticipated endpoints
* Judged to be at risk for poor compliance to the study protocol.
* Lack of informed consent.
Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations: a Randomized Clinical Trial

Although the Atraumatic Restorative Treatment (ART) is well settled in the literature regarding occlusal-proximal cavities, the longevity of these restorations is still lower when compared to occlusal ones. This factor is often associated with low mechanical properties of glass ionomer cements (GIC). The objective of this randomized clinical trial is to evaluate the long-term cost-effectiveness of two different materials: an encapsulated GIC - Equia (GC Corp), compared with Giomer (Beautifill Bulk Restorative - Shofu) used as restoratives materials in occlusal-proximal ART restorations of primary molars. Children aged between 4 and 8 years, will be selected in schools in the city of Cerquilho, São Paulo. All restorations will be held following the precepts of the ART and the manufacturer's instructions. The restorations will be evaluated after 3, 6, 12, 18 and 24 months according to Roeleveld et al. (2006) criteria. To verify the survival of the restorations will be used Kaplan-Meier survival analysis and log rank test. To evaluate the association between the clinical variables, Cox regression test will be applied. For the cost analysis will be used analysis of variance. The level of significance for all tests will be considered to 5%.


Eligibility Criteria:
Inclusion Criteria:

* Children aging between 4 and 8 years
* Children presenting good health conditions
* Children whose parents or legal guardians accept and sign the consent form
* Children with at least one occlusal proximal caries lesion in primary molars
* only occlusal-proximal surfaces with caries lesions with dentin involvement

Exclusion Criteria:

* severe behavioral issues
* presence of fistula or abscess near the selected tooth
* presence of pulp exposure in the selected tooth
* presence of mobility in the selected tooth
Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale

This study, based on preliminary experimental results, literature review, and expert consultations, developed the Attentional Rating Scale (ARS). The aim was to rapidly assess participants' attention and potential influencing factors. The research focused on the scale's reliability and validity among healthy adults. Additionally, the Attention Network Test (ANT) served as the gold standard for evaluating attention. The study attempted to identify correlations between various dimensions of attention and the three attentional networks.

1. To adiministrate 60 healthy subjects to evaluate internal consistency reliability.
2. To choose 20 cases for ARS retesting 7 days after the first ARS evaluation.
3. To evaluate the split half reliability through the Spearman Brown coefficient.
4. To apply principal component analysis for structural validity analysis.
5. Using the Attention Network Test (ANT) and Toronto Hospital Alertness Test (THE) as gold standards, the Pearson correlation coefficient was used for criterion validity analysis.
6. To administrate 60 patients with MDD, ADHD and insomnia disorder testing the discrimination validity of ARS.

Eligibility Criteria:
Inclusion Criteria:

1. Major Depressive Disorder (MDD) or attention deficit hyperactivity disorder (ADHD) diagnosed according to DSM-5, or Chronic Insomnia Disorder diagnosed according to ICSD-3
2. Ages between 18 and 60 years old
3. Right-handed
4. Educational level ≥5 years or IQ ≥90, capable of understanding and reading Chinese.

Exclusion Criteria:

1. Currently diagnosed with any other DSM-5 mental disorders (according to MINI 7.0) or ICSD-3 sleep-wake disorders, apart from MDD, ADHD or insomnia disorder
2. Currently and past history of neurological disorders and physical illnesses with subjectives
3. Consumed alcohol in the week preceding the enrollment
4. Using antidepressants, antipsychotics, mood stabilizers, or other central nervous system-acting drugs for at least 4 weeks in the current episode
5. Undergoing any physical treatments such as ECT, neuromodulation therapy or Traditional Chinese Medicine treatment in the past 6 months
6. Refused to sign the informed consent form
Acute Exposure of Simulated Hypoxia on Heart Rate and Ventilation During Exercise

Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FIO2: 15.1% = equivalent to 2500m above sea level) on heart rate and Ventilation changes under exercise.

Low altitude baseline measurements will be performed in Zurich (469m asl) including Echocardiography, right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas analysis at rest and under exercise.

Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device.

During the exposure to simulated altitude (FiO2: 15.1%) and shamed altitude of 1 hour each, the participants' heart rate and Ventilation will be compared under exercise.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting partial oxygen pressure (PaO2) ≤7.3 kilopascal (kPA) corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, high-altitude pulmonary edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding
Intravenous TNK vs TPA for AIS Treatment on MSU,a Prospective Multicenter RCT

Acute ischemic stroke is one of the devastating diseases that increase hospitalization, disabilities, and deaths worldwide. Current treatment with intravenous thrombolytic agent can help reduce disabilities and improve quality of life. Intravenous Alteplase is proven benefit and now used as the first-line drug for acute ischemic stroke with symptom onset less than 4.5 hours and without contraindications.

Tenecteplase, a genetically engineered tissue-type plasminogen activator, has been questioned to treat acute ischemic stroke instead of intravenous alteplase. Tenecteplase has more advantages over alteplase including higher fibrin specificity, longer half-life and easier to administer as a single intravenous bolus. The efficacy and safety of intravenous tenecteplase has been studied recently. In 2017, A phase 3 randomized open-label, blinded trial (NOR-TEST) 6 showed that there were no significant differences in efficacy and safety between tenecteplase and alteplase in mild stroke patients. A study in 2020, in the setting of acute large artery occlusion, Tenecteplase resulted in a better 90-day neurological outcome and provided more benefits in reperfusion before endovascular thrombectomy10. Regarding safety concerns, tenecteplase showed no significant higher incidence of intracerebral hemorrhage. Administration, tenecteplase might be better in the setting of the case on mobile stroke units. Assuming, earlier reperfusion by thrombolytic drug may have improved patient's neurologic outcomes. We aim to compare the efficacy and safety between intravenous tenecteplase and alteplase in acute ischemic stroke patients given on mobile stroke units within 4.5 hours after symptom onset.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as Acute ischemic stroke within 4.5 hr of symptom onset
* Age \> 18 years old
* No contraindication for thrombolytic drug
* Informed consent from patients

Exclusion Criteria:

* Diagnosed as Acute ischemic stroke with more than 4.5 hours of symptom onset or uncontained onset
* Have contraindication for thrombolytic drugs
Dysport for the Treatment of OMD

The purpose of this study is to study the efficacy and safety of AbobotulinumtoxinA (Dysport) for use in Oromandibular Dystonia (OMD).

Oromandibular dystonia (OMD) is an uncommon, disabling form of cranial dystonia, involving involuntary movements of the lower facial, masticatory, and lingual muscles. This can cause jaw movements including opening, closure, protrusion, retraction, or deviation. Common additional facial movements involve grimacing or lip pursing. When there is tongue involvement, it usually presents as tongue protrusion or curling. Such patients are impaired in relation to eating, speaking and swallowing

This study aims to evaluate the efficacy and safety of a low dose of Dysport® deemed tolerable during phase 1 in subjects with oromandibular dystonia (OMD).

Participants will be injected with Dysport® only, with an unblinded open-label disclosure. The safety and efficacy pf receiving Dysport® will be recorded for all subjects that undergo injection. All subjects will be examined and videotaped at the injection visit, then at 6 and 12 weeks after injection with a standardized protocol. The primary outcome will be blinded examination scores of the videos performed after the study is complete.The evaluators will be three different movement disorders experts, not otherwise involved in the study, who will review the videotaped examinations, presented in a random order, using the Global Dystonia Rating scale (GDS). Evaluators will rate the dystonia at baseline (injection visit) and 6 weeks after injection.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of primary or tardive OMD
* moderate or severe severity, defined as GDS score ≥4 in either "lower face" or "jaw and tongue" section
* capability of attending the scheduled visits
* only those who have been previously injected with onabotulinumtoxinA and responded to that treatment, and are at least 12 weeks post last injection
* Women of childbearing age need to use contraception in order to be included.

Exclusion Criteria:

* Existence of a systemic disease that could confound the evaluation
* previous placement of Deep Brain Stimulation electrodes to treat dystonia
* concomitant oral medications that could interfere with the action of botulinum toxin Type A (e.g., aminoglycosides)
* on an unstable dosage of any medication prescribed to treat dystonia (e.g., benzodiazepines, baclofen or anticholinergics)
* any known hypersensitivity to any botulinum toxin preparation and allergy to cow's milk protein
* immunoresistance to other forms of botulinum toxin type A
* existence of a concomitant neuromuscular disorder (e.g., Myasthenia Gravis or Lambert-Eaton syndrome, etc)
* infection at the proposed injection sites
* pregnant women
* women of childbearing age NOT on contraception
* breastfeeding women
* inability to comply with scheduled visits
* patients who had been previously injected with botulinum toxin type A but who did not respond
RHODOS Follow-up Single-visit Study

This study aims to evaluate the current visual acuity of SNT-II-003 participants and compare this with the last visit from the SNT-II-003 study.


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in study SNT-II-003
Study to Evaluate Effects of Investigational Drug on Oxygenation in Healthy Volunteers Under Hypoxic Conditions

To evaluate the effect of GBT440 on oxygen saturation at rest and exercise, under hypoxic conditions, at Day 15 compared to Baseline.

This study in healthy subjects will evaluate GBT440 and its effects on cardio-pulmonary function under both normoxic and hypoxic conditions.

Eligibility Criteria:
INCLUSION CRITERIA

1. Males or females aged 18 - 50 years inclusive
2. Able and willing to provide signed informed consent to participate in this study
3. VO2 max ≥ 40 mL/kg/min for males, and ≥ 35 mL/kg/min for females
4. Weight ≥ 40 kg
5. Male or female of child bearing potential willing and able to use highly effective methods of contraception during the study to 30 days after the last dose of study drug.

EXCLUSION CRITERIA

1. Subjects whose exercise regimen at Screening is, in the Investigator's opinion, expected to change significantly during the study
2. Family or personal history of congenital long QT syndrome
3. Participated in another clinical trial of an investigational drug (or medical device) within 30 days or 5-half-lives, whichever is longer, prior to Screening, or is currently participating in another trial of an investigational drug (or medical device)
4. Clinically significant medical disease that is likely, in the Investigator's opinion, to significantly impact the study's efficacy and safety assessments (e.g., history significant cardio-pulmonary disease or arrhythmias) within 6 months of Screening.
5. AST, ALT or total bilirubin \>2 × ULN
6. Serum creatinine \>1.5 mg/dL
7. Clinical evidence of active infection, within 21 days of Screening, which may include but is not limited to bronchitis, pneumonia, urinary tract infection, or cellulitis.
8. Female who is breast-feeding or pregnant
9. Current smoker or history of smoking within 3 months from Screening
10. Any condition possibly affecting drug absorption, including but not limited to previous surgery on the stomach or small intestine
11. Known hypersensitivity to any component of the study drug
RTMS for Refractory Auditory Hallucinations Based on Personalized Targets Using Magnetoencephalography

This study is an before-after study in the same patient, which enrolled 36 psychiatric patients with refractory auditory hallucinations. The target of patient intervention relies on the results of magnetoencephalography localization. The medication and dosage remain unchanged during the intervention period. The investigators assume that the intervention targets for each auditory hallucination patient are individualized.

This study is divided into two parts:

1. Target determination. Firstly, MEG data of the patient's resting and task states are collected, and a precise localization model using magnetoencephalography is applied to locate the precise location of the patient's abnormal signals in the brain, which is then used as the intervention target. Based on the patient's tolerance for single day intervention, the appropriate number of targets is generally 2-4. The upper limit of targets is 4.
2. RTMS individualized intervention. Application of rTMS for 1Hz low-frequency intervention, with intervention parameters of 1400 sessions, 100% exercise threshold, and a total of 23 minutes per session. After each target intervention, rest for half an hour to one hour. The pseudo stimulation intervention lasted for 10 days in the first and second weeks, and the scale was evaluated after the end of the pseudo stimulation. After resting for 2 weeks, enter the 3-4 weeks of real stimulation, with 5 days of intervention per week for a total of 10 days. 2-4 targets per day, 23 minutes per target, with 30-60 minutes between interventions for each target. After the fourth week, evaluate the scale. Follow up evaluations will be conducted on the 7th, 14th, 30th, 60th, and 90th day after intervention. By analyzing and evaluating data, explore individualized treatment plans for auditory hallucinations in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia
* Must be able to right-handed
* Primary school education or above
* Understand and sign a written informed consent form (jointly signed by the guardian and the participant if under 18 years old)
* Existence of persistent auditory hallucinations (defined as: taking sufficient antipsychotic medication for at least 6 months, combined with 3 antipsychotic medications still ineffective, and no significant improvement in auditory hallucinations symptoms, with an AHRS score still\>12)

Exclusion Criteria:

* MECT treatment within the past 3 months
* Major physical illnesses (organic lesions such as sensory and motor disorders, neurological disorders, and traumatic brain injury)
* Taboo symptoms for rTMS treatment (such as intracranial metal implants)
* Aggressive behavior and an impulse to damage equipment
* Metal (including orthodontic treatment, dental implants) and tattoos inside the body
* Claustrophobia
Identification of Neuroprognostic Factors for Out-of-hospital Cardiopulmonary Arrest (MIRA29)

From the informatized prehospital care registry, data will be collected anonymously for all patients' requiring cardiopulmonary resuscitation for an out-of-hospital cardiac arrest within the Norther Finistere sanitary region.

First step of the model derivation will consist in multivariate analysis to extract the most pertinent variates associated with neurological outcome (evaluated using the CPC Score); Second step will consist in the use of artificial intelligence and machine-learning to derive the most discriminant score.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest requiring cardiopulmonary resuscitation

Exclusion Criteria:

* Death before cardiopulmonary resuscitation
* Pediatric Patients
Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

In recent studies, a radiation-induced enteropathy is being reported over 50%. In clinics, probiotics are actively prescribed as a treatment for radiation-induced enteropathy. If probiotics can be used during radiation therapy to prevent or reduce radiation-induced enteropathy, the investigators can 1) reduce the inconvenience which is caused from intestinal toxicity, 2) reduce the unnecessary interruption of radiation therapy, and 3) expect to improve the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven uterine cancer, ovarian cancer, vaginal cancer, vulvar cancer, ureter cancer, kidney cancer, urethral cancer, and prostate cancer
* Over 20 years of age
* Eastern Cooperative Oncology Group (ECOG) score 0-2
* Appropriate values of blood test within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, platelets≥50000cells/mm3
* Appropriate values of kidney function within 6 months after enrollment Creatinin \< 2.0 ng/dL
* Appropriate values of liver function within 6 months after enrollment Total bilirubin \< 1.5 times upper limit normal range, alanine aminotransferase or aspartate aminotransferase \< 2.5 times upper limit normal range.
* Willing to provide informed written consent

Exclusion Criteria:

* History of pelvic irradiation
* Double primary cancer other than skin/thyroid cancer
* Combined serious morbidity
* Experience of other clinical trial within 1 month.
The Dark-Adapted Retinal Function Response in Choroideremia (DARC) Study

Choroideremia (CHM) is an inherited retinal disorder that causes progressive vision loss, ultimately leading to complete blindness. The first symptom is generally night blindness, although, to date, little is known about the extent, type, pattern, and progression of dark-adapted visual function measures in CHM patients. We hypothesize that one of the key events causing night blindness in CHM is deficiency in the chromophore of the rod visual pigment, rhodopsin. We propose that this deficiency is at least in part due to inadequate delivery of vitamin A (all-trans-retinol) to the photoreceptors (PRs) from the ailing retinal pigment epithelium (RPE), characteristic of CHM. We hypothesize that increased availability of vitamin A would potentiate its entry into the RPE-mediated visual cycle, ultimately enabling delivery to the PRs. This would in turn allow rods to perform better by partially overcoming the RPE damage and the impaired chromophore recycling that we postulate exists in CHM. The goals of this proposal are: (1) to test the hypothesis that oral vitamin A supplementation can improve night time and peripheral vision in CHM patients, and (2) to provide detailed characterization of dark-adapted visual function outcome measures to guide interventional CHM trials.


Eligibility Criteria:
Inclusion Criteria:

* males at least 15 years of age with molecularly-confirmed diagnosis of choroideremia

Exclusion Criteria:

* inability to participate in visual field testing reliably and reproducibly