cyrilzakka/clinical-trials huggingface dataset:
IRIS PILOT - Extended Pilot Study With a Retinal Implant System

Investigate whether blind subjects that fulfil the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross.

The Retinal Implant System consists of three main components, the Retinal Stimulator, which is the component actually implanted into the eye, the visual interface, and the Pocket Processor The Retinal Stimulator will be implanted into the eye of a blind subject during a surgical operation. However, the external components are activated only during the test sessions under the control of the investigator team. In a first step of the investigation a software controlled system on a PC which is connected to the Pocket Processor via Ethernet interface, will generate the defined stimulation patterns (bars, crosses, cubes). During the test session, the blind subject is exposed to a series of these stimulation patterns and he / she has to describe the visual perceptions. Based on his descriptions and in an interactive way, the stimulation signal is subsequently be modulated by changing parameters like amplitude, duration of impulse, polarity, number of repetitions or pulse frequency on the PC.

In a second step the visual interface is equipped with a camera which presents realtime images to the subject. Data obtained from the investigation with computer generated patterns in the first step are used in the second step to improve the fitting software for the use in the camera supported system.

Finally the system should enable the subject to recognize simple images supported from the camera.

Eligibility Criteria:
Inclusion Criteria

* Age between 30 and 79 years at the date of enrollment
* Normal hearing and linguistic understanding (with hearing aids if - necessary and in the language of the hospital or in English)
* Ability to understand the study and procedures involved
* Willingness to participate and comply with follow-up procedures
* Good general health based on investigator's opinion
* Ability to undergo surgery using general anaesthesia
* Signed informed consent
* RP, choroideremia, or rod cone dystrophy
* Visual field less than 40 ° (if measurable)
* Visual acuity not better than (1/50), (logMAR≥1.7)
* Visual function stable for a duration of at least one year (according to subject statement)
* Normal eye pressure (9-21 mmHg)
* Bulbus length (AP) between 21 and 25 mm

Exclusion Criteria

* Allergic response to multiple antibiotics
* Known allergies to materials of the implant
* Known carrier of multi-resistant organisms
* Pregnancy or lactating
* History of epileptic seizures
* Having active implantable devices (or need within the next 3 years)
* Patients with cancer or patients received cancer therapy within the last 2 years
* Currently undergoing psychiatric treatment without expert opinion approving participation on the study
* Patients having insufficient mental capacity
* Neurological diseases, in particular those affecting nerve conduction velocities
* Patients currently taking medications affecting brain function
* Immunosuppressive subjects
The UTHealth Medical-Legal Partnership: Improving Health by Addressing Health-Harming Legal Needs

The purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of the UTHealth medical-legal partnerships (MLP) against usual care.


Eligibility Criteria:
Inclusion Criteria:

* English- or Spanish- speaking
* screen positive for health-harming legal needs (HHLNs)

Exclusion Criteria:

* Those unable or unwilling to consent to legal services
The Incidence and Nature of Adverse Events During Pediatric Sedation for MRI/CT in One Korean University Hospital: Prospective Study

Sedation and anesthesia for which to perform diagnostic imaging represents a rapidly growing field of practice, especially in children. Propofol is the most common sedative drug administered for MRI/CT. However, this drug is associated with adverse events, including pulmonary complications, and there has been no report on these complications in Korea. In this prospective observation study, the investigators will report the nature and frequency of adverse events associated with propofol-based sedation for MRI/CT.


Eligibility Criteria:
Inclusion Criteria:

* Requiring sedation for MRI/CT, aged 0- 18 years

Exclusion Criteria:

* Parent refusal of participation
Preferences in Pain Treatment: A Discrete Choice Experiment in Patients With Peripheral Neuropathic Pain (pNP)

The objective of this study is to identify and weight attributes of topic and systemic pain treatment options relevant from the patients' perspective with peripheral neuropathic pain. The study will use a discrete choice experimental design to reach its objective.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed peripheral neuropathic pain (pNP) as assessed by study sites

Exclusion Criteria:

* Patients with no sufficient knowledge in written or oral German as assessed by study sites
Bioequivalence Study of Losartan Potassium (100 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Cozaar® (100 mg Tablet) [Reference Formulation, Merck & Co. Inc., USA] in Healthy Human Volunteers Under Fasting Condition

Objective:

The purpose of this study is to compare the single dose bioavailability of Torrent's Losartan Potassium Tablets 1 × 100 mg and Cozaar® Tablets 1 × 100 mg of Merck \& Co., Inc.

Study Design:

Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* The volunteers were Included from the study based on the following criteria:
* Sex: male.
* Age: 18 - 45 years. .
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

* The volunteers were excluded from the study based on the following criteria:
* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute.
* Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines,
* Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgement of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality.

The objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR.

TOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 70 years
2. Symptomatic severe aortic stenosis defined by an aortic valve area ≤1.0 cm2 or an aortic valve area indexed to body surface area \<0.6cm2/m2
3. Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision

Exclusion Criteria:

1. Life expectancy \<1 year irrespective of valvular heart disease
2. Inability to provide informed consent
3. Participation in another clinical trial with an active intervention
Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced: a Multicenter, Open-label, Randomized Phase III Studyunresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

To compare the efficacy and safety of tislelizumab combined with FOLFOX or combined with POF in the treatment of locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma with CPS≥1


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
* 18-70yeas.
* ECOG PS 0-1.
* No previous chemotherapy (perioperative chemotherapy, six months after fluorouracil alone or one year after oxaliplatin or a combination of taxoid and fluorouracil can be included), radiotherapy or immunotherapy.
* With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
* Life expectancy ≥3 months.
* With normal electrocardiogram results and no history of congestive heart failure.
* With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
* Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of Tislelizumab until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug.
* With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
* Have a known PD-L1 CPS/MMR (or MSI) /HER2(FISH) test result, or have sufficient samples for relevant testing.

Exclusion Criteria:

* Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
* Patients with brain or central nervous system metastases, including leptomeningeal disease.
* Pregnant (positive pregnancy test) or breast feeding.
* Serious, non-healing wound, ulcer, or bone fracture.
* Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
* History of a stroke or CVA within 6 months.
* Clinically significant peripheral vascular disease.
* HIV-positive, active hepatitis B or C (HBV, HCV);
* Inability to comply with study and/or follow-up procedures.
* Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
* Her2-positive (IHC 3+ or 2+/FISH+) patients.
Effectivity of Motor Imagery and MirrorTherapy in Amputees

This study evaluates the effectiveness of imagery motor on phantom pain and amputation process

The expected increase in the number of amputations in the coming decades requires special attention to the common effect after called phantom limb amputation. That term refers to the phenomena covering the sensations that occur in the affected limb and whose prevalence rate is an important part of amputees subjects. Developed theories about their origin focus their attention on the central nervous system and the peripheral nervous system. Thus, the imaginary movement is a complex cognitive, sensory and proprioceptive process leading to a mental representation of movement and it is a widely used technique in neurological rehabilitation and complex pain syndrome.

Eligibility Criteria:
Inclusion Criteria:

1. Pain in the stump area ≥ 3 months, no intermittent
2. Have three months elapsed amputation,
3. Submit subjective sensation of phantom limb not blinking

Exclusion Criteria:

* Clinical signs of radiculopathy.
* Lumbar stenosis, fibromyalgia, spondylolisthesis.
* History of spinal surgery.
* Corticosteroid therapy in the past two weeks.
* Disease of the central nervous system or peripheral.
Cervical Spinal Cord Stimulation in Cerebral Vasospasm

The study is a non-blinded evaluation of the use of cervical spinal cord stimulation (SCS) for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence of cerebral vasospasm.

The study is a non-blinded evaluation of the use of cervical spinal cord stimulation (SCS) for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence of cerebral vasospasm. Stimulation will be provided with electrodes placed percutaneously in the upper cervical epidural space. The outcome of 5 patients will be studied with focus on possible adverse events related to the intervention. Vasospasm response to treatment will be measured as a secondary outcome. Middle cerebral artery flow velocity will be followed by transcranial Doppler and clinical outcome measured by NIH stroke scale. Flow velocities will be monitored daily by transcranial Doppler and NIH stroke scale performed daily for 7 days, after which spinal cord stimulation will be discontinued and the epidural lead removed.

Eligibility Criteria:
Inclusion Criteria:

* a history of aneurysmal subarachnoid hemorrhage and will have aneurysm secured by clipping or coiling.
* evidence of vasospasm on TCD with MCA mean flow velocity \>120 cm/s.
* Patients must be clinically stable to leave the ICU for the study intervention.
* Patients will have Hunt and Hess grade 1-2 non-traumatic subarachnoid hemorrhage.
* Patient should be oriented patients able to provide informed consent.

Exclusion Criteria:

* Patients with non-aneurysmal hemorrhage
* Patient with coagulopathy (PTT\>40, or INR \> 1.2)
* thrombocytopenia (platelets \<100 x 103 per mm2).
* Use of anticoagulation or antiplatelet medication within the known clinical effective period of the particular medication.
* allergy to nimodipine.
* History of cervical or thoracic spine surgery.
* Skin infection at site of catheter placement.
* Sepsis. Pregnancy. Age less than 18 or greater than 80. Active diagnosis of cancer or history of metastatic cancer. Presence of cardiac defibrillator. Inability or unwillingness of patient to give informed consent. Patients found to be clinically neurologically unstable, hemodynamically unstable, or suffering from unstable intracranial pressure at the time of assessment for lead placement will not have the intervention.
Long-term Follow-Up Study Following Treatment With Fate Therapeutics' Engineered Cellular Immunotherapy

The purpose of the study is to assess long-term side effects from subjects who receive a Fate Therapeutics genetically modified NK cell product. Subjects who previously took part in a Fate Therapeutics study and received genetically changed NK cells will take part in this long-term follow-up study. Subjects will join this study once they complete the parent interventional study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.

For a period of 15 years starting from the last administration of Fate Therapeutics genetically modified NK cell product, subjects will be assessed for long-term safety and survival through questionnaires and blood tests.

This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who received a Fate Therapeutics NK cell product that has been modified by lentivirus-mediated genetically engineering. The period of follow-up is 15 years after the administration of the NK cell product.

The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Fate Therapeutics clinical studies. Upon withdrawal or completion of the parent interventional study, the study site will contact the subject/healthcare provider/legal guardian annually.

Eligibility Criteria:
Inclusion Criteria:

* Received engineered cellular immunotherapy in a Fate Therapeutics Interventional Study

Exclusion Criteria:

• Not Applicable
Nit-Occlud PDA Post-Approval Study

The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and effectiveness of the device in the post-approval phase.


Eligibility Criteria:
Inclusion Criteria:

* Angiographically confirmed PDA with minimum diameter \< 4 mm.
* Weight is ≥ 5 kg.
* Age 6 months to 21 years.

Exclusion Criteria:

* Cardiac anomalies requiring surgery.
* Known bleeding or coagulation disorder.
* Febrile illness within 7 days of planned procedure.
* Pregnancy.
* Pulmonary hypertension with increased pulmonary vascular resistance (≥ 5 Wood Units).
* Hypersensitivity to contrast medium.
* Known nickel allergy.
Intraoperative Frozen Section Pathology to Guide Surgical Treatment for Lung Adenocarcinoma (ECTOP-1015)

This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1015). The goal of this clinical trial is to confirm the concordance rate between intra-operative frozen section pathological diagnosis and post-operative paraffin embedded pathological diagnosis, and use this result to guide surgical treatment for early stage (cT1N0M0) lung adenocarcinomas.


Eligibility Criteria:
Inclusion Criteria:

* Patients who sign the informed consent form and are willing to complete the study according to the study protocol;
* No previous history of cancer or pulmonary surgery;
* Solitary lesions or multiple lesions with only one not manifesting as pure ground-glass opacity (GGO) on CT scan;
* Peripheral clinical T1N0M0 patients that are eligible for surgery;
* Non-small cell lung cancer is pathologically diagnosed before or at surgery;
* No radiation therapy or chemotherapy before surgery.

Exclusion Criteria:

* Patients with clinical stages other than T1N0M0;
* The lesion cannot be completely resected;
* Previous history of cancer;
* Patients having received radiation therapy or chemotherapy.
Pharmacist Interventions in Rural Elderly Warfarin Patients

The primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years
* Living site of participant outside the city eg. rural site
* Expected duration of warfarin therapy at least 6 months from the inclusion in the study and 3 months before

Exclusion Criteria:

* Hospitalization
* Vegetarianism
* Patients not able to provide an informed consent
* The use of drug that has an X level of clinical significance of interaction with warfarin according to Lexicomp interact base
The Effect of Perturbration on Balance Control in Adults

Balance control in respond to an unexpected platform perturbration during standing and walking: comparison between individuals with chronic ankle instability and healthy individuals.

An unexpected postural perturbration is a major risk factor of falls and injuries during gait. A postural perturbration is a sudden change in conditions that displaces the body posture away from equilibrium. Reactive postural control response is an immediate ( 70-120 ms ) automatic "like reflex" response which is initiated by unexpected postural perturbration in order to maintain balance. Even among young healthy adults there could be a problem in balance performance which does not become evident untill a slip or a trip or any other sudden perturbration happens. Thus a simple test of pertubration while standing or walking can identify a problem .

This study is comparing the reactive postural control of physical education students who suffer from chronic ankle instability (CAI) to healthy students on a Perturbation Treadmill. The device consists of a treadmill mounted on a moving force plate platform. The platform moves in the medial/ lateral plains to simulate a slip and a trip in both the standing and walking phase. Their reactive postural control is tested in a few conditions: standing on both legs - eyes open and eyes closed, in tandem standing, standing on one leg and in walking. In each condition the perturbration is given every 5-15 seconds in different speed and in unexpected direction (right /left). Lost of balance control is any change in the original location of the foot in standing conditions or stepping out of the treadmill.

Eligibility Criteria:
Inclusion Criteria:

* age 18-50
* good health
* active people

Exclusion Criteria:

* Body weight greater than 135 kg
* Bone instability (non-consolidated fractures, unstable spinal column, severe osteoporosis)
* Head damage in the year prior to the study
* Diabetics or Unstable circulation
* Cardiac (blood) contraindications
* Vestibular problem
* Neurological deficits
* Mechanical ventilation problem
* Severe vascular disorders of the lower limbs