cyrilzakka/clinical-trials huggingface dataset:
Proprioception of the Knee Post MIS TKA and MIS-QS TKA

If the proprioception of the affected knee post total knee arthroplasty (TKA) can recover earlier, it will accelerate the regaining of motion control ability and motion control accuracy of the TKA patients. This study compared the proprioception difference of the post operation knees between the MIS-QS TKA group and the MIS TKA group.The differences of proprioception recovery were analyzed following the two different TKA procedures and the advantages of MIS-QS TKA in the recovery of knee. proprioception were discussed.

Patients were scheduled prospectively to undergo total knee arthroplasties were randomly assigned to receive either a MIS-QS TKA or a MIS TKA. Proprioception of the knee position sense was assessed by the knee angle reproduction test (10\~20 degree, 30\~40 degree, 80\~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation. Paired two-tailed t tests with a level of significance of p \< 0.05 were used to assess the effect of the different arthroplasty procedure on the postoperative knee joint proprioception for all subjects.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of osteoarthritis
* Indication of TKA

Exclusion Criteria:

* Bilateral total knee replacements
* Rheumatoid arthritis
* Genu valgus over than 10 degrees and genu varum over 15 degrees
* ROM (Range of motion) of preoperative knee joint less than 100 degree.
Effect of Rosiglitazone on Myocardial Blood Flow Regulation in Type 2 Diabetes

The overall hypothesis to be tested is that increased insulin resistance contributes to abnormal cardiac blood flow regulation in type 2 diabetic patients, which can be reversed by 6 months treatment with rosiglitazone. The planned experimental approach will be to utilize nuclear medicine techniques to evaluate whether the administration of rosiglitazone for 6 months can reverse regional deficits in myocardial blood flow and glucose utilization in type 2 diabetes in a randomized double blind controlled study. These studies will help elucidate the potential of rosiglitazone to correct deficits of myocardial blood flow complicating diabetes with the overall aim being the eventual prevention of sudden cardiac death.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* 30-75 years of age
* less than 1% fluctuation in HbA1c over 3 months
* women must be on contraception
* HbA1c 6-9%
* willingness to sign approved consent form

Exclusion Criteria:

* Nursing mothers, pregnant women (excluded by a negative pregnancy test).
* Subjects requiring insulin therapy (\>20 units/day) and can not be converted to sulfonylurea therapy without loss of diabetes control.
* Patients with a history of drug or alcohol dependence in the last 5 years
* Patients with pre-existing cardiovascular disease including coronary artery disease, heart attack, heart failure, abnormal heart rhythms, structural abnormalities and valve disease, peripheral vascular disease and uncontrolled high blood pressure.
* Patients with a history of high cholesterol requiring therapy.
* Patients with severe systemic disease other than diabetes which has as a recognized complication neuropathy
* Patients currently taking drugs which act on the blood vessels (for example for hypertension)
* Patients taking antidepressants, or other drugs or medications known to interfere with the uptake or metabolism of catecholamines (stress hormones)
* Patients with poor renal function or have significant liver disease
* Patients with a history of previous kidney, pancreas or cardiac transplantation.
* Patients with a history of "severe hypoglycemia" which required the assistance of a third party or ketoacidosis requiring hospital admission within the last 3 months.
* Patients with lung disease for example resulting from chronic obstructive airways disease.
* Patients with abnormal thyroid function tests.
* Patients having taken other systemic investigational drugs (especially for neuropathy) or initiating a new or experimental insulin delivery device within 3 months of starting the study.
* Patients with a history of allergic reactions to multiple drugs or biological products.
* Obese patients (BMI greater than 35).
* Patients who refuse to sign the informed consent.
Pharmacokinetics of PN-235 in Healthy Volunteers

This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-235 in healthy volunteers. The study will be conducted in three parts: Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is a randomized, crossover solid dose comparison and effect of food study.

Part 1: Approximately 40 subjects randomized into 5 cohorts to receive PN-235 or placebo as single doses.

Part 2: Approximately 50 subjects enrolled into 5 cohorts to receive PN-235 or placebo once daily for 10 days.

Part 3: Twelve subjects will receive single doses of PN-235 in a 4-way, randomized, crossover fashion.

In total, approximately 102 subjects will participate.

Eligibility Criteria:
Key Inclusion Criteria:

* Subjects must have BMI between 18 and 32
* Subjects must be non-smokers or social smokers
* Subjects must comply with contraception requirements
* Subjects must be willing to consume meals provided by the clinical center

Key Exclusion Criteria:

* Subject must not have history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years
* Subjects must not have history of surgical resection of the stomach, small or large intestine
* Subjects must not have fever or symptomatic viral or bacterial infection within 2 weeks of screening
* Subjects must not have corrected QT greater than 450 msec in males and 470 msec in females
* Subjects must not test positive for Hepatitis C or B at Screening
* Subjects must refrain from use of prescription and non-prescription drugs and herbal remedies prior to initial dose of study drug and throughout the study
Efficacy and Safety of CD5024 1% in Acne Vulgaris

Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using intra-individual comparison involving subjects with acne vulgaris on face to evaluate the efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.

Study drugs application will be performed once daily, 5 days a week during 6 weeks

Eligibility Criteria:
Inclusion Criteria:

1. The subject is a male or a female aged from 18 to 35 years old at screening visit.
2. The subject has a medical diagnosis of acne vulgaris :

   2.1 at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred) non-inflammatory lesions (nose is excluded for the lesion count) at Baseline

   2.2 symmetry of the lesions: No more than twice as many acne lesions on one side as compared to the other side at Baseline
3. If the subject is a female of childbearing potential, she must agree to use an effective contraceptive method for the duration of the study

Exclusion Criteria:

1. The subject has an underlying known disease surgical or medical condition, in the opinion of the investigator might interfere with interpretation of the study results or put the subject at risk (e.g., other dermatological diseases affecting the treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or serious diseases which would normally prevent participation in any clinical study, such as a cancer, leukemia or severe hepatic impairment), (Screening).
2. The subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
3. The subject has a known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator's Brochure/Product label).
4. The subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (Screening and Baseline).
Observational Study of Keratoconus and Post-keratoplasty Eyes

A prospective observational study on keratoconus and post-keratoplasty will be conducted. We will enroll 50 subjects in each of 3 groups: keratoconus, post-PK, and post-DSAEK. The Optovue anterior segment OCT prototype will be used to perform 3-D corneal scans. These scans will be used to measure corneal thickness (pachymetry), corneal topography (anterior and posterior) and epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will also be used when they become available. A comprehensive eye examination, Placido-ring corneal topography, ultrasound pachymetry, and Scheimpflug camera imagery, will be performed for comparison. In some post-PK and post-DSAEK cases, vision will be primarily affected by regular astigmatism, myopia, or hyperopia, rather than HOA. These cases can be corrected by standard PRK (not OCT guided) with adjunctive mitomycin C treatment to prevent haze formation.107, 108 In these cases PRK will be performed according to the standard of care and will not be a part of the study protocol. The postoperative results will be observed at the 3-4 month visit with UCVA, manifest refraction, BSCVA, OCT scanning, Placido topography, ultrasound pachymetry, and Scheimpflug camera imagery


Eligibility Criteria:
Inclusion Criteria:

• Adults (18 \& older) with keratoconus, keratoplasty, DSAEK procedures

Exclusion Criteria:

* Inability to give informed consent.
* Inability to maintain stable fixation for OCT imaging.
* Inability to commit to required visits to complete the study.
The Effects of Sevoflurane and Desflurane on QT Interval Measured With Cardiac Electrophysiological Balance Index

The primary aim of this study is to compare the effects of sevoflurane and desflurane on the QT interval. The secondary aim of this study is to compare the effects of drugs used in the induction and maintenance of anesthesia on the QT interval by calculating the Bazzet formula and iCEB.


Eligibility Criteria:
Inclusion Criteria:

1. ASA I-II-III risk group
2. the operation time is longer than 1 hour in the Urology department.

Exclusion Criteria:

1. bundle branch block in preoperative ECG,
2. Non-sinus heart rhythm,
3. QT length in preoperative ECG,
4. using drugs that cause known QT prolongation ( beta-blocker drugs using will be included),
5. development of malignant arrhythmia that will disrupt hemodynamics in the intraoperative period,
6. patients with electrolyte disorders,
7. patient refusal -
Microsampling Approach for Monitoring of Kinase Inhibitor Targeted Therapies

The MISTIK project aims at clinically validating the technique of oral anticancer drugs determination by volumetric absorptive micro-sampling and at comparing the results to measurements performed on venous samples.

The International recommendations for the validation of DBS-based methods will be applied (Capiau et al, TDM, 2019) by including 40 patients per molecule of interest. Nine drugs will be monitored : axitinib, olaparib, regorafénib, cabozantinib, niraparib, talazoparib, palbociclib, abemaciclib, tucatinib.

Two samples will be collected from each patient, one by venous sampling and the second at the same time (approximately) using a capillary blood sample derived from a finger prick.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with one of the 9 drugs concerned by the study : axitinib, olaparib, regorafénib, cabozantinib, niraparib, talazoparib, palbociclib, abemaciclib, tucatinib
* person who does not object to their participation in the research

Exclusion Criteria:

* Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty
Colchicine Counteracting Inflammation in COVID-19 Pneumonia

Cytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections \[3\]. Patients with severe COVID-19 have higher serum levels of pro-inflammatory cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to individuals with mild disease or healthy controls, similar to patients with SARS or MERS . The change of laboratory parameters, including elevated serum cytokine, chemokine levels, and increased NLR in infected patients are correlated with the severity of the disease and adverse outcome, suggesting a possible role for hyper-inflammatory responses in COVID-19 pathogenesis. Importantly, previous studies showed that viroporin E, a component of SARS-associated coronavirus (SARS-CoV), forms Ca2C-permeable ion channels and activates the NLRP3 inflammasome. In addition, another viroporin 3a was found to induce NLRP3 inflammasome activation . The mechanisms are unclear.

Colchicine, an old drug used in auto-inflammatory disorders (i.e., Familiar Mediterranean Fever and Bechet disease) and in gout, counteracts the assembly of the NLRP3 inflammasome, thereby reducing the release of IL-1b and an array of other interleukins, including IL-6, that are formed in response to danger signals. Recently, colchicine has been successfully used in two cases of life-threatening post-transplant capillary leak syndrome. These patients had required mechanically ventilation for weeks and hemodialysis, before receiving colchicine, which abruptly restored normal respiratory function and diuresis over 48 hrs \[4\].


Eligibility Criteria:
Inclusion Criteria:

* Positive nasopharyngeal swab for COVID-19, asymptomatic or paucisymptomatic, aged ≥70 years and/or with clinical risk factors for poor outcome (clinically relevant chronic lung disease, diabetes and/or heart disease) or
* symptomatic with respiratory or systemic symptoms, however clinically stable (MEWS\<3) with CT imaging showing viral pneumonia and positive or pending pharyngo-nasal swab for COVID-19: Temperature 38°C and/or intensive cough, Respiratory rate \< 25 /min, oxygen saturation (pulse oximetry) \>95%
* Positive swab for COVID-19
* with respiratory and/or systemic symptoms and initial mild respiratory failure e with objective signs of lung involvement; the patient is in stable conditions (MEWS \< 3) Temperature\>38°C and or intensive cough, Respiratory rate ≥25 /min, or oxygen saturation 94- 95% in room air

Exclusion Criteria:

* Pregnant or breast feeding
* MEWS \>=3
* Hepatic failure Child-Pugh C
* Enrollment in other pharmacological studies
* Ongoing treatment with colchicine
* Ongoing treatment with antiviral drugs that include ritonavir or cobicistat
* Any medical condition or disease which in the opinion of the Investigator may place the patient at unacceptable risk for study participation.
36 Versus 42 Hour Time Interval From Ovulation to Intrauterine Insemination

The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH antagonists.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who can be monitored for follicle growth and hormone measurements on the day of ovulation trigger, or one day before.
2. Patients who have no more than 4 follicles of 14 mm or more
3. Patients who have no more than 6 follicles of 10 mm or more

Exclusion Criteria:

1. Patients who cannot give informed consent to language or comprehension barriers
2. Patients who are deemed to be at high risk for high order multiple gestations
3. Patients who cannot be monitored on the day of hCG administration or one day before
Healthcare Resource Utilization and Costs in Metastatic Melanoma Patients Initiated Dabrafenib + Trametinib and Encorafenib + Binimetinib

This was a retrospective cohort study using the MarketScan health care administrative claim databases: Truven Health Analytics' MarketScan Commercial Claims and Encounters; MarketScan Medicare Supplement and Coordination of Benefit. We conducted this analysis using the most recent available data from the MarketScan database at the time of analysis, which was 01 June 2018 to 31 December 2020. We initiated this analysis from 01 June 2018 as encorafenib + binimetinib (enco/bini) was approved for patients with unresectable or metastatic melanoma with BRAF mutation at this time.


Eligibility Criteria:
Inclusion Criteria:

* At least one diagnosis of malignant melanoma (The International Classification of Diseases, 9th Revision \[ICD-9\] codes: 172.0-172.9 or V10.82; ICD-10 codes: C43.0 C43.10 C43.20 C43.30 C43.31 C43.39 C43.4 C43.59 C43.60 C43.70 C43.8 C43.9 D03.0 D03.10 D03.11 D03.12 D03.20 D03.21 D03.22 D03.30 D03.39 D03.4 D03.51 D03.52 D03.59 D03.60 D03.61 D03.62 D03.70 D03.71 D03.72 D03.8 D03.9 Z85.820) in the study period.
* A diagnosis of metastasis (ICD-9 196.x, 197.x, 198.x, 199.x \& ICD-10 C77.xx, ICD-10 C78.xx, ICD-10 C79.xx, ICD-10 C80.xx) within 30 days before or 60 days after their malignant melanoma diagnosis.
* A prescription (pharmacy or medical claim) of enco/bini or dab/tram as a 1L therapy after the metastatic melanoma diagnosis date.
* At least ≥18 years as of the index date.
* At least 6 months of continuous enrollment before index date and 6 months after index date.

Exclusion Criteria:

* Patients with a diagnosis of other primary malignancy (ICD-9: 140.xx-165.xx, 170.xx-171.xx, 173.xx-195.xx, 200.xx-208.xx; ICD-10: C00.x - C14.x, C41.x, C49.x, C50, C51) during the 6 months pre-index period.
* Patients with pregnancy (ICD-9: 630.xx-679.xx, V22.xx-V24.xx, V27.xx-V28.xx; ICD-10: O00 - O99) any time during the study period.
* Patients with more than one melanoma-related drug prescription other than the index drug, on the index date.
Assessment of Pre Hospital Rescue Intervention for Seizure in Pediatric Patients

1. Evaluation of pre hospital rescue intervention of seizure management.
2. To investigate the type of rescue medication, Efficacy, route of administration, Side effects of this drug, frequency and Indication of its use.

An epileptic seizure is a transient occurrence with signs or symptoms due to abnormal excessive and synchronous neuronal activity in the brain.

There are many different types of seizures:

Current classification designates two large categories - partial or generalized. In a partial seizure, one area of the cortex is thought to be activated initially and may show simple symptoms such as a motor or sensory phenomena.

Partial seizures may rapidly secondarily generalize and spread to involve all cortical areas.

Generalized seizures result from diffuse cortical activation at seizure onset . Seizure cluster provides an opportunity to administer prompt treatment.

Delays in the treatment of seizure emergencies are often associated with negative patient outcomes.

Seizure clusters become less responsive to treatment when they continue unabated over time .

In addition to using anti epileptic medications, the treatment of seizures aims at correcting any identifiable causative process. Care is needed to prevent any secondary brain injury, which may include advanced respiratory and cardiovascular support. Monitoring is necessary to detect hypotension and hypoxia and steps taken to correct those conditions when recognized. Common complications may include traumatic injuries such as tongue lacerations or scalp lacerations . Convulsive status epileptic leads to brain damage on the cellular level and may itself be epileptogenic. Transformed or subtle generalized convulsive status epileptic or non convulsive seizures detected by EEG monitoring in critically ill patients may also contribute to brain laceration .

Eligibility Criteria:
Inclusion Criteria:

* Patient with recurrent attack of seizure and with prolonged seizure with prescribed treatment at home.
* Patients aged from 2 years to 18 years

Exclusion Criteria:

* First attack of seizure
* condition mimic epilepsy
Sex Steroids and the Serotonin Transporter

The aim of this study is to prove the influence of the sex steroid hormones estrogen, progesterone and testosterone on the serotonin transporter (5-HTT) binding using positron emission tomography (PET) and the selective radioligand \[11C\]DASB. Specifically, the 5-HTT binding will be quantified before and after hormone therapy underwent by 10 male-to-female (MtF) and 10 female-to-male (FtM) transsexuals urging for hormone treatment. The high-level, long-term administration of opsite sex steroid hormones in transsexuals provide the unique opportunity to investigate the influence of sex steroid hormones on the serotonergic system. Since the serotonin transporter serves as a primary target molecule for antidepressant treatment, the results of the study will be of benefit for the assessment of the clinical relevance of estrogen and testosterone as modulatory and neuroactive agents.


Eligibility Criteria:
Inclusion Criteria:

* somatic health
* no previous sex hormone medication
* willingness to sign the written informed consent

Exclusion Criteria:

* severe diseases
* steroid hormone treatment within 6 months prior inclusion
* treatment with psychotropic agents such as selective serotonin reuptake inhibitors (SSRIs)
* any implant or stainless steel graft
* positive urine pregnancy test in women at the screening visit at each PET day
a Comparison Between the Effectiveness of Vestibular and Dual Task on Balance in Diplegic Children

the study is carried out to identify If there is any difference between the effectiveness of Vestibular training and Dual task training on balance in children with Diplegic Cerebral Palsy.

so in this study the sample will be divided into two equal groups, each group will recieve only one type of training ( vestibular training or dual task training ) the balance of the diplegic children will be assessed before and after using HUMAC balance system and pediatric balance scale , the results will be compared between both groups and if there is one training is more effective than the other , it will be recommended most in the future treatment program.

A comparative experimental design was used. Children participating in this study were assigned into two equal groups, Thirty four children with diplegic Cerebral Palsy of both genders who have balance problems were selected to join this study with the following criteria:

1. all the children diagnosed as diplegic cerebral palsy.
2. Their age are range from 5 to 10 years old.
3. The degree of spasticity is between grade 1 or 1+ according to Modified Ashworth Scale (Charalambous ,2013).
4. They are at level I OR II on Gross Motor Function Classification System .
5. All the children were able to follow verbal command and instructions.

And Children were excluded in the presence of the following:

1. Children that suffer from epilepsy.
2. Severe visual and auditory problems.
3. Structural or fixed soft tissue deformities of Lower extremities.
4. Severe mental retardation.
5. Botox injection in the lower extremity in the past 6 months..

all the children will be assigned in one of two groups ( vestibular training group and dual task group ) the training will be continue for definite period of time , and the balance abilities for the children in each group will be assessed before and after the treatment completely ended and the result will be compared to conclude which group benefit more and have a greater balance improvement and the treatment that causes a greater improvement will be more recommended in the future physical therapy plan for treatment of diplegic cerebral palsied children.

the balance is assessed using HUMAC balance system and pediatric balance scale .

Eligibility Criteria:
Inclusion Criteria:

1. clinical diagnosis of diplegic cerebral palsy .
2. age range : from 5 to 10 years old.
3. The degree of spasticity is between grade 1 or 1+ according to Modified Ashworth Scale (Charalambous ,2013).
4. They are at level I OR II on Gross Motor Function Classification System .
5. All the children were able to follow verbal command and instructions.

Exclusion Criteria:

1. Children that suffer from epilepsy.
2. Severe visual and auditory problems.
3. Structural or fixed soft tissue deformities of Lower extremities.
4. Severe mental retardation.
5. Botox injection in the lower extremity in the past 6 months