cyrilzakka/clinical-trials huggingface dataset:
MTF Image Modifications

Human visual acuity and contrast sensitivity are highly dependent on various different parameters. Each should be optimized for perfect visual performance. However, in real life our eyes lack such parameters, which might lead to unsatisfying results even after spectacle correction or contact lenses.

A promising approach would be to design intra ocular lenses (IOL), which are implanted into the eye for example in the course of cataract extraction and are able to compensate for the human eyes' aberrations.

For example cutoff frequency, edge-sharpness or specific contrast for selected structure sizes would need to be considered. Since, an aberration free optical system is almost impossible and since the impact of each single parameter is not yet known, IOL design parameters would have to be chosen very carefully.

Furthermore, image quality of IOLs still is tested ex vivo by ray tracing for example, but this does not guarantee perfect function after implantation, as our visual system has complex image precessing units form the retina to the brain.

The present study picks one of these parameters and seeks to assess its impact on visual quality in-vivo. By subjectively grading different images with objective changes to image quality by variations of the modulation transfer function (MTF), the potential influence and thus on our subjective visual impression shall be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years, nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, emmetropia or ≤ 1 diopter

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except oral contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
Walking Adaptability Post-Spinal Cord Injury

The purpose of this study is: (1) to establish assessment techniques (in our laboratory) to identify the functional integrity of long spinal tracts associated with adaptive walking recovery post-spinal cord injury and (2) to preliminary investigate locomotor outcomes associated with an adaptive locomotor training approach post-spinal cord injury.

Eligible individuals without spinal cord injury that are enrolled in the study will participate for 1-2 days. These individuals may undergo a variety of non-invasive neurophysiological tests which evaluate spinal reflexes and integrity of specific spinal pathways. In addition, their movement may be assessed during walking on a treadmill and overground in a variety of different conditions (e.g. with mirrors, without mirrors, with obstacles, without obstacles).

Eligible individuals with spinal cord injury that are enrolled in the study will undergo the same testing as described above for the healthy controls. In addition, a small subset of these individuals may receive locomotor training (3 weeks of basic locomotor training followed by 3 weeks of adaptive locomotor training, separated by a 3 week washout period). For the individuals receiving locomotor training, they will be tested before and after each 3 week training session.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* no neurologic injury (for individuals without SCI)
* \>12 mos post-incomplete SCI (iSCI), discharged from in- and out-patient rehabilitation, with diagnosis of first time motor iSCI (AIS C or D with upper motor neuron lesions at cervical or thoracic levels) (for individuals with SCI)
* medically stable condition with no changes in anti-spasticity meds
* ability to walk in the home and/or ambulate in the community using a single cane or crutch, bilateral canes or crutches, or no device
* walking speeds \> 0.3 m/sec, with deficit performance on the Dynamic Gait Index
* medically approved for participation

Exclusion Criteria:

* current participation in another rehabilitation program/research protocol
* history of congenital SCI or other degenerative spinal disorders
* inappropriate or unsafe fit of the harness and/or joint contractures or severe spasticity that would prohibit the safe provision of training
* receipt of a therapeutic intervention or medication within the last 6 mos that would alter the nervous system's ability to respond to treatment (e.g. Botox injections)
* unable to safely receive transcranial magnetic stimulation due to positive history which prohibits its use
Lactoferrin + Vitamin E + Zinc for Hormonal Acne

We previously showed that twice daily intake of a combination of 100 mg lactoferrin, 11 IU vitamin E, and 5 mg zinc significantly reduced both inflammatory and non-inflammatory acne lesions compared to placebo control. In that study, females showed an overall better response compared to males in terms of total lesions. We speculated that the gender effect may be due to mitigation of the pre- menstrual flare-ups women have that lead to recurring acne, making them have a better response. The objectives of this study are: 1.) to characterize the efficacy and safety of 100 mg lactoferrin + 11 IU vitamin E + 5 mg zinc in the adult female population who suffer from hormonal acne, 2.) to determine whether the anti-acne effect is maintained after treatment stops.


Eligibility Criteria:
Inclusion Criteria:

1. Females aged 22-50.
2. At least 3 inflammatory acne lesions, mostly found on (but not limited to) the lower face
3. Not responsive to conventional treatment
4. Clinical diagnosis of mild to moderate acne according to Lehmann et. al.

Exclusion Criteria:

1. Females who are pregnant (confirmed by a pregnancy test), breast- feeding, or planning a pregnancy.
2. Post-menopausal women
3. Current or recent (within 3 months) use of any topical or oral anti- acne products,
4. Hormonal contraceptive intake in the preceding six months
5. A cancer diagnosis within the past 5 years
6. History of hypersensitivity to any component of the test product.
7. Current imuunosuppression. Specifically, these include patients with co-morbidities such as diabetes, HIV, chronic diseases patients requiring maintenance medications, such as vascular disease,

   * hepatitis, eczema, psoriasis, or acute febrile/infectious illnesses
   * (i.e. Dengue, pneumonia, etc)
Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer

The combination of radiation therapy or chemoradiation with Interstitial brachytherapy for advanced cervical cancer (pN+, FIGO-Stage II B - IV A is standard of therapy. The radio- and chemosensitive effect of an additional hyperthermia might improve the clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmed carcinoma of the Cervix
* FIGO-Stage IIB-IVA; earlier stages when inoperable or according to patient's wish
* clinical M0; except: involvement of para-aortic lymph nodes
* Age ≥ 18 years
* ECOG ≤ 2
* Informed consent of the patient

Exclusion Criteria:

* Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
* Cardiac Pacemaker
* Myocardial infarction within the past 12 months
* Congestive heart failure
* Complete bundle branch block
* New York Heart Association (NYHA) class III or IV heart disease
* Disease that would preclude chemoradiation or deep regional hyperthermia
* Metal implants (length \> 2cm or dense clusters of marker clips in the pelvis)
* Active or therapy-resistent bladder infections
* Pre-existing or concommitant immunodeficiency Syndrome
* Pregnant or lactating women
* Patients not willing to use effective contraception during and up to 6 months after therapy
EAdi as a Predictor of Successful Extubation in Patients With Traumatic Cervical Spinal Cord Injury

Esophageal recordings of diaphragm electrical activity (EAdi) made it possible to monitor respiratory drive and the subsequent phrenic nerve conduction and respiratory neuromuscular function continuously. Thus, we designed a "spontaneous breathing challenge" test to monitor the change in EAdi after a maximal inspiration. We hypothesized that the absolute change (ΔEAdi) and the percentage changes change (ΔEAdi%) in EAdi after a "spontaneous breathing challenge" predict successful extubation in traumatic CSCI patients during acute hospitalization.

A retrospective cohort study enrolled adult traumatic CSCI patients who underwent mechanical ventilation and admitted to the intensive care unit (ICU) of Zhongda hospital form June 2014 to July 2018. The following inclusion criteria were used: age 18 years or older, traumatic CSCI patients with a neurologic level of injury of C1 to C8 by the American Spinal Injury Association (ASIA) standard impairment scale grade A-D patients with mechanical ventilation due to acute respiratory failure and admite to ICU, dedicated nasogastric tube with nine electrodes that allow to continuously measure diaphragm electrical activity (EAdi catheter, Maquet, Solna, Sweden) in postion. CSCI was defined as radiologically-confirmed injury to the cervical spinal column, combined with clinical signs and symptoms consistent with CSCI at that level. The exclusion criteria were: tracheostomy at time of addmition to ICU, withhold or withdraw life sustaining treatment due to other serious organ injury, can't complete instructional actions, death occurred within 7 days after injury, or postoperative MV was a direct result of surgery and had duration of less than 24 hours postoperatively. Extubation or tracheostomy was decided by the physician in charge according to the local protocol of weaning.

Eligibility Criteria:
Inclusion Criteria:

1. age 18 years or older
2. Traumatic CSCI patients with a neurologic level of injury of C1 to C8 by the American Spinal Injury Association (ASIA) standard impairment scale grade A to D
3. patients with mechanical ventilation due to acute respiratory failure and admit to ICU
4. with dedicated nasogastric tube with nine electrodes that allow to continuously measure diaphragm electrical activity (EAdi catheter, Maquet, Solna, Sweden) in position.

Exclusion Criteria:

1. tracheostomy before ICU admission
2. withhold or withdraw life sustaining treatment due to other serious organ injury
3. can't complete instructional actions,
4. death occurred within 7 days after injury
5. postoperative MV was a direct result of surgery and had duration of less than 24 hours postoperatively.
6. EAdi data not available
EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease

The purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study treatment works in the study) of the study medicine (called nirmatrelvir/ritonavir) for potential treatment of coronavirus disease 2019 (COVID-19).

The study medicine will be given to patients under 18 years of age with COVID-19 that are not hospitalized but are at risk for severe disease.


Eligibility Criteria:
Inclusion criteria:

* Male and female, age 0 to \< 18 years, able to swallow for some participants
* Confirmed SARS-CoV-2 infection within 72 hours prior to enrollment
* Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of enrollment and at least 1 of the specified COVID-19 signs/symptoms present at enrollment
* Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19

Exclusion Criteria:

* History of or need for hospitalization for the medical treatment of COVID-19
* Total bilirubin \>=2X upper limit of normal (ULN) (except for Gilbert's syndrome)
* Receiving dialysis or have known moderate to severe renal impairment
* Suspected or confirmed concurrent active systemic infection other than COVID-19
* History of hypersensitivity or other contraindication to any of the components of the study intervention
* Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or strong inducers of cytochrome P450 (CYP)3A4
* Has received or is expected to receive antibody treatment, antiviral treatment or convalescent COVID-19 plasma
* Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the study follow up
* Females who are pregnant or breastfeeding
Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease

Medical cannabis (MC) is a standard treatment in Israel to Parkinson's disease (PD) patients suffering from pain. Nevertheless, it is not known about MC effectiveness for other non-motor symptoms of the disease. Our aim is to prospectively observe patients with PD before and after initiation of MC, for non-motor symptoms effect. In specific, relying of data from multiple sclerosis patients and basic science showing cannabinoid receptor 1 (CB1) is abundantly expressed in the sub epithelial layer of the bladder, we will explore the impact of MC on bladder function and urinary symptoms.

This is a prospective, open-label, observational study. Patients with Parkinson's disease (PD) receiving licensure from Israeli Ministry of Health (MOH) for using medical cannabis (MC) for PD related symptoms and pain, being followed up in the Movement Disorders Institute (MDI) at SHEBA Medical Center (SMC) will be eligible to participate. Assessment regarding patient demographic, disease characteristics (Hoehn and Yahr, disease duration, disease first symptom etc.) will be collected at baseline along with designated questionnaires to evaluate the non-motor symptoms (NMSS, PDSS, Kings PD pain scale, PDQ8) and urinary function (Bladder over activity, International prostate symptom score (IPSS) and nocturia questionnaires). after MC initiation, patients will be observed and evaluated for the impact of MC 4-8 weeks following treatment initiation. Also, for each patient, MC being used will be analyzed in order to expose relationship between phyto-cannabinoid content and efficacy or side effects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease according to UK Parkinson's disease society barin bank clinical diagnostic criteria
* Holds a validated Medical cannabis license, from Israeli Ministry of health
* Able to sign informed consent
* Age 18-80

Exclusion Criteria:

* Use of Medical cannabis in the previous 30 days prior to study recruitment visit
* Concomitent severe co-morbidities able to influence outcomes such as spinal injury, cancer, dementia.
* Cannot sign informed consent
Safety and Effectiveness of Artemisinin-based Combination Therapies (ACTs) With Repeated Treatments for Uncomplicated Falciparum Malaria Over a Three-year Period

A community-based, open-label, cluster-randomised longitudinal study in which children are randomized according to village health worker catchment areas comparing the safety and effectiveness of repeated treatments with artemether-lumefantrine (AL) over a 3-year period in children 4-48 months to that of repeated treatment with dihydroartemisinin-piperaquine (DHA-PPQ).


Eligibility Criteria:
Inclusion criteria

1. Aged between 4 months and 11 months at the time of randomization
2. Bodyweight ≥ 5 kg at the time of randomization
3. Provision of informed consent by parent or guardian
4. Intention to stay in the study area for the time of the study

Exclusion criteria

1. Ongoing participation into another clinical study involving ongoing or scheduled treatment with medicinal products
2. Intent to reside outside of catchment area during the course of the study
3. Known hypersensitivity to the study drug randomized to
4. Known pre-existing hearing problem or neurological impairment
5. Known need at the time of randomization for concomitant prohibited medication
6. Suspected non-compliance with the follow-up schedule
Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease

The study concerns a retrospective analysis of all subjects operated as of 1st Jan 2008 using Minimal Access Surgical Technique (MAST). The study is descriptive in nature and will present the observation of all cumulated patients operated with MAST.

The study data will include the general health information of the subjects prior to surgery, information on the surgery such as OP time, blood loss, and the postoperative wound healing process (until discharge), which is on average the 10th postoperative day.


Eligibility Criteria:
Inclusion and Exclusion Criteria:

* all patients who underwent minimal access spinal surgery for degenerative lumbar disease fusion surgery
* patient older than 18 years
* all products have been used within intended use
Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia

Although the current standard for lumbar puncture and spinal anesthesia is the use of manual palpation of surface landmarks to identify the correct interspace, performance of the procedure at too high of a level may increase the incidence of adverse effects. The current study will evaluate the efficacy of ultrasound in identifying the correct intervertebral space for lumbar puncture thereby improving the safety of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients less than 1 year of age scheduled for spinal anesthesia for elective lower abdominal, urologic, or lower extremity surgery at Nationwide Children's Hospital

Exclusion Criteria:

* Parents unwilling for their children to undergo spinal anesthesia for surgery.
* Children with known spinal anomalies including sacral dimple.
* Children with coagulation abnormalities or receiving anticoagulation which precludes the use of spinal anesthesia.
* Children with superficial or deep infections over the spine which precludes the use of spinal anesthesia.
Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor

The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal misoprostol for cervical ripening and induction of labour.

There are many pregnant women require medical intervention to induce labor for some reasons at term. There are two fundamental changes that characterize pre-labor preparation for delivery: sensitization of the myometrium to produce contractions, and ripening (softening and dilation) of the cervix. A synthetic Prostaglandin misoprostol is fundamental to both of these changes. Low dose misoprostol is effective and safe for labor induction and has been used widely.

Oral tablets(200mcg) are broken into fragments and used intravaginally to ripen the cervix and induce labor due to the disadvantages of existing cervical ripeners (delivery of bolus doses, freezer or refrigerated storage, lack of efficacy in labor induction), and due to safety concerns with the off-label use of oral misoprostol tablet fragments, Regenex Corporation has developed a vaginal tablet with 25mcg misoprostol.

The primary objective of the study was to assess of the efficacy and safety of low dose (25 mcg) of misoprostol vaginal tablet for cervical ripening and induction of labour.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy.
* Aged 20 years or older.
* At term (37 to 42 weeks inclusive gestation).
* Cephalic presentation (normal lie).
* No rupture.
* Bishop score ≤6.
* With an indication for labour induction.
* Written informed consent.

Exclusion Criteria:

* Any contraindication to vaginal delivery.
* Previous of uterine scar(Cesarean section or other uterine surgeries).
* Heavy or repeated vaginal bleeding in third trimester of pregnancy.
* Have a history of glaucoma,asthma or epilepsy.
* Contraindication to prostaglandin use.
* Known severe allergy to prostaglandin.
* Placenta previa
* Premature rupture of membranes
* Placental abruption
* Fetal malpresentation(Breech or Transverse)
* Obvious cephalopelvic disproportion
* Amniotic Fluid Index more than 250mm or less than 50mm
* Fetal growth restriction
* Fetal malformation
* Fetal distress
* Preeclampsia or eclampsia
* Fetal macrosomia of prenatal diagnosis(B-type ultrasonic inspection/Abdomen estimates)
* Intrahepatic cholestasis syndrome(ICP)
* Pregnancy with severe heart, lung, liver, kidney, endocrine disease and immune dysfunction
* Pregnancy with acute systemic infection
* Pregnancy with Severe anemia
* Cervical carcinoma
* Some genital tract infection disease, such as active herpes infection
* Take part in other clinical trials within three months.
* The person that investigator thought not be enrolled.
A Study of Q-1802 in Patients With Advanced Solid Tumors

Q-1802 is a bispecific antibody targeting both the tumor-specific antigen Claudin 18.2 and the immune checkpoint PD-L1. This is a multi-center, single-arm, open-label design to evaluate the safety and tolerance of Q-1802 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy. The study consisted of two compartments: the dose-exploration stage and the dose-extension stage.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age ≥18 years and ≤75 years.
* Patients with at least one measurable lesion per RECIST (v1.1) (applicable to the dose-extension stage).
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening and no deterioration occurs within two weeks before enrollment.
* Life expectancy period ≥ 12 weeks.
* Patients who have sufficient baseline organ function and whose laboratory data meet the following criteria (receiving no treatment of blood transfusions, albumin, recombinant human thrombopoietin, or colony-stimulating factor within 14 days before the first dose of this study).
* Patients with advanced gastric mucinous adenocarcinoma, advanced ovarian mucinous carcinoma or other dominant tumors participating in the dose-extension stage must provide eligible tumor tissue samples for biomarker detection; if subjects agree, tumor tissue samples should also be provided during the dose-exploration stage.

Exclusion Criteria:

* Patients who have received any prior PD-1/PD-L1 antibody therapy (applicable to the dose-exploration stage).
* Patients with uncontrolled blood pressure (systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or previous hypertensive crisis or hypertensive encephalopathy.
* Patients with active peptic ulcer, gastric outlet obstruction or persistent recurrent vomiting.
* Patients with a history of monoclonal antibody allergic reaction.
* Patients who are considered ineligible by the investigator due to any other severe, acute or chronic disease or other causes that the investigator considers could affect the patient's participation or assessment in the study.