cyrilzakka/clinical-trials huggingface dataset:
MRD Monitoring in Lung Cancer After Resection

The conception of molecular residual disease (MRD) extending from hematologic tumor to solid tumors. Evidences supporting MRD evaluation for lung cancer by liquid biopsy has gradually accumulated, especially circulating tumor DNA (ctDNA). In this observational study, the investigators prospectively enroll stage I-IIIA non-small cell lung cancer (NSCLC) patients who underwent complete resection. Preoperative blood sample, tumor tissue and dynamic postoperative blood samples are collected continuously for MRD detection. This study aim to explore the prognostic value of MRD for stage I-IIIA NSCLC patients after complete resection.

There will be a rapid surge in research about molecular residual disease (MRD) for solid cancer in the near future. However, MRD differed significantly between tumor types and between contexts; there continues to be a considerable lack of awareness and knowledge about using MRD in lung cancer. Hence, this study aims to investigate the value of MRD in NSCLC patients who underwent complete resection. Preoperative blood sample (20ml), tumor tissue and dynamic postoperative blood samples (20ml) are collected continuously for MRD detection. The follow-up was performed once every 3 to 6 months. The primary objective of this study is to assess the prognostic value of MRD for stage I-IIIA NSCLC patients after complete resection.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage I-IIIA) disease.
* Complete resection
* Age ≥18 years at the time of screening
* Capable of giving signed informed consent

Exclusion Criteria:

* Mixed small cell and NSCLC histology
* Rx, R1 or R2 resection
* History of other malignant tumors within 5 years
Brain Health in the Time of COVID-19

This is a nationwide research program to study the neurological effects of COVID-19. It is open to the public. Healthy individuals and individuals who are or have been infected with COVID-19 are encouraged to join the effort. The study can be done at home with internet access and an iPad or iPhone. Participation takes about one hour.

To learn more, go to https://www.mirohealth.com/consent/

Neurological complications have been reported in patients with COVID-19. To better understand neurological complications, a group of research hospitals are collaborating to track neurological outcomes. We know that COVID-19 can invade our nervous system, but little is known about the range of effects that COVID-19 might have on the brain. This study aims to gain real-time information about the neurological health of the U.S. population to advance knowledge of COVID-19.

At the conclusion of the study, you will receive non-medical information on your brain function as well as study findings and publications made possible by your participation. With your permission, Miro Health can also release the results of your assessment to your physician. In order for Miro Health to do this, you will be required to confirm your identity online, sign a HIPAA agreement to share the information with your physician, and to enter your physician's name, email, and contact information. Study duration will depend on the development of the COVID-19 pandemic.

To participate, you must submit a valid email. No other personally identifiable information will be gathered at this time.

To participate, you will:

Answer online questions Answer a few questions about your health Download the Miro Health app from the iTunes store Open the app and complete Miro's interactive tasks (30 mins)

Advisory: Should you feel that you have symptoms related to COVID-19, contact your healthcare provider or local community health office. Miro Health cannot provide healthcare assistance.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Access to an iPad bought in 2013 or later
* Access to stable Wi-Fi
* Access to iTunes

Exclusion Criteria for healthy:

* Below age 18
* Preexisting neurological, psychiatric, or developmental disorder
Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery.

the primary objective of this study is to investigate the sedative, and analgesic effects of oral, or nebulized ketamine as premedication drugs, and providing postoperative analgesia for the preschoolers and decrease their need for systemic analgesia.The secondary objective is to compare each sedation technique after oral, or nebulized ketamine for safety ,and procedural outcomes.

Preoperative communication, premedication interventions, and being accompanied by parents are useful methods in decreasing preoperative separation anxiety , postoperative psychological trauma, and ensuring smooth induction for preschoolers undergoing elective surgery.

Procedural sedation, and analgesia was defined by O'Donnell as a drug induced state of decreasing awareness, pain, and memory that allowing patient continue his ,or her own protective reflexes, and moving purposefully( O' Donnell etal, 2003).

Ketamine is an anesthetic drug having sedative, and analgesic properties with different routes of administration in children (IV, intramuscular, subcutaneous, oral, rectal, sublingual, intranasal, and nebulized) .

Ketamine produces its analgesic properties in acut pain management from reversible antagonizing the N-methyl-D-aspartate (NMDA)receptors , reducing levels of many proinflammatory mediators in the acute phase, and acting on other non-NMDA pathways that playing important roles in pain, and mood regulation, like its effect on µ-opioid receptors, nicotinic, muscarinic cholinergic, ɣ-aminobutyric acid receptors, activation of high -affinity D2 dopamine receptors, and L-type voltage-gated calcium channels.

The oral route is the most popular than other routes ,as it's safe, efficient, acceptable, and familiar for pediatric patients..

Oral ketamine often requires higher, and frequent doses as it's bioavailability is lower (17-24%) compared to IV (100%),Intramuscular (93%), sublingual/transbuccal(30%), intranasal(25-50%),and inhaler (70%) due to extensive first pass metabolism in liver, and intestine.

Ketamine inhalation is safe, rapid absorption, and affordable route of administration.

Eligibility Criteria:
Inclusion Criteria:

* Parents acceptance.
* Age (3-6) years old.
* American Society of Anesthesiologist physical status (ASA) I / II
* Elective surgery of approximately half to one hour duration under general anesthesia.
* Child With Body Mass Index (BMI) (15-18kg/m²)

Exclusion Criteria:

* Parents refusal.
* Altered mental status, and epilepsy.
* History of allergy to ketamine.
* Recent respiratory tract infection.
* Sever dysfunction of the central nervous system.
* Increased intracranial pressure, and increased intra-ocular pressure.
* Cardiac dysrhythmia ,and/or congenital heart disease.
Selective Sentinella Lymph Node Biopsy with Indocyanine Green in Patients with Breast Cancer

The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique.

In the operating room 1 ml of indocyaninge grenn will be injectec periareolar . After 5 minutes the lymph node will be detected and extracted. The comparison between the lymph nodes detected with Technetium 99 and indocyanine green will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age with breast cancer who are candidates for sentinel lymph node detection will be included.
* N0 patients or patients who have undergone target axillary detection with good response

Exclusion Criteria:

* Lymphadenectomy
ELAZOP Switching Study in Korea

The purpose of this study is to assess the safety and efficacy of switching to ELAZOP from prior pharmacotherapy in patients with open-angled glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
* Must be on a stable regimen of Intraocular Pressure (IOP) lowering medication (i.e., either a single therapeutic agent or two separate ocular hypotensive agents) for at least one month prior to the Screening Visit.
* Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
* Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in the study that is deemed clinically significant in the opinion of the Principal Investigator.
* Intraocular conventional surgery or laser surgery in either eye less than three months prior to the Screening visit.
* History of ocular herpes simplex.
* Pregnant or lactating.
* Participation in any other investigational study within 30 days of Screening visit.
* Other protocol-defined exclusion criteria may apply.
Rehabilitation After Total Knee Arthroplasty (TKA) - PFC Rotating Versus Fixed Bearing

The purpose of this study is to determine whether patient rehabilitation is equal for patients operated with two different knee implant designs.

The patients are randomized to treatment with either a simple hinge design implant (fixed bearing) or an implant with a mobile bearing polyethylene. This design difference might in principle enable the patients in the latter group to rehabilitate towards a more normal gait pattern.


Eligibility Criteria:
Inclusion Criteria:

* Patients at Silkeborg Regional Hospital, Orthopedic Dept. referred to total knee arthroplasty.

Exclusion Criteria:

* Neurologic disease with impact on gait.
* Orthopaedic disease ipsilateral hip joint.
* Patients outside the age limits.
* No informed consent signed.
* Patients suffering from dementia.
* Patients primarily included, but who perioperatively has their posterior cruciate ligament injured or sacrificed.
* Patients who later develop deep venous thrombosis or infection in the operated knee.
Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Women

Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which is being studied for possible prevention and treatment of postmenopausal osteoporosis.

PREMARIN® (conjugated estrogens \[CE\]) is approved by FDA to treat moderate to severe symptoms of menopause (i.e., hot flashes, and/or vulvar and vaginal atrophy) and for the prevention of postmenopausal osteoporosis.

The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of PREMARIN® when administered together with multiple doses of bazedoxifene (BZA) to healthy postmenopausal women.

Information will also be obtained regarding the safety and tolerability of the study medications when given together to healthy postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, postmenopausal woman, (either naturally or surgically and have blood hormone levels consistent with a postmenopausal state for specified subjects) between the ages of 35 and 70 years, inclusive
* Have not participated in a clinical drug study for at least 30 days prior to study medication administration,
* Must not have a history of drug or alcohol abuse within 1 year and do not consume more than 2 standard units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of 80-proof alcohol or 6 ounces of wine)
* Must either be a non-smoker or smoke less than 10 cigarettes per day, and must be able to abstain from smoking during clinic confinements,
* Must not donate any other plasma or blood during the total study.
* All test results and study criteria for the study are met.

Exclusion Criteria:

* Only healthy postmenopausal women are eligible.
* Health assessed by clinical chemistry laboratory results and physical exam.
Neurodynamic Intervention for Lumbar Radiculopathy

Low back pain (LBP) is a common condition and has a significant impact on the individual in terms of pain and disability. Lumbar radiculopathy occurs often with LBP and may be the result of a lumbar herniated disc which will irritate a lumbar nerve trunk resulting in intraneural inflammation. There is evidence supporting the use of manual therapies of lumbar radiculopathy. One potential manual therapy is neurodynamic mobilization technique. No scientific evidence, based on a RCT, exists that this particular approach is beneficial for individuals with LBP and lumbar radiculopathy


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a confirmed (via MRI) disc herniation at between L4 and S1 level;
* Subjects exhibiting lumbar radiating pain in the lower extremity for at least 3 months
* Subjects with a positive straight leg raise with symptoms reproduction

Exclusion Criteria:

* indication for surgical intervention;
* had a confirmed disc herniation at other lumbar levels;
* have had any other spinal conditions such as spinal tumors or spondylolisthesis;
* had received treatment for this condition by a physical therapist the previous 6 month;
* pregnancy
Pilot Study of a Decision Aid Intervention for Family-building After Cancer

This study tests a web-based decision aid and planning too to help young female cancer survivors manage fertility and family-building issues in post treatment survivorship.

The overall goal of this work is to pilot test a single-arm intervention of a decision aid and planning tool (website) to assist young adult female cancer survivors in making decisions and preparing for family-building after cancer.

Primary Objective: Examine feasibility and acceptability of a decision aid intervention in a single-arm pilot trial.

Secondary Objective: Obtain preliminary effect sizes of the decision aid intervention using a pre-post study design.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Completed cancer treatment known to have gonadotoxic effects (e.g., systemic chemotherapy, surgery affecting reproductive organs or hormone regulation, and/or pelvic radiation)
* Understands verbal and written English
* Desires future children or uncertainty regarding family-building plans
* Access to the Internet and use of a computer, tablet, or smartphone

Exclusion Criteria:

* Currently undergoing cancer treatment excluding long-term adjuvant or maintenance therapies, such as tamoxifen
* Significant physical or mental disability that prevents completion of study activities

Note: Survivors on adjuvant maintenance or endocrine treatment, such as tamoxifen, will not be excluded because clinical guidelines allow treatment delay or hiatus to accommodate fertility preservation, egg extraction for surrogacy, or pregnancy for some patients, and because patients may be interested in alternative family-building options such as surrogacy or adopting.
Effects of Dynamic Compression Garments in Children With CP

In recent years, it is seen that dynamic compression garments are used to increase body stability and to provide tone regulation. Dynamic compression garments are used to apply pressure to specific muscles or muscle groups. Different studies have drawn attention to the effect of dynamic compression garments on postural control and proximal stability. Researchers observed that upper extremity functions and fine motor skills improved with the use of clothing, and they associated this with improved proximal stability. In light of this information, the aim of this study is; To investigate the effects of dynamic compression garments applied in addition to traditional treatment on posture, trunk control, and upper extremity functions during sitting in children with hemiparetic CP.

Cerebral palsy (CP) is a group of permanent neurodevelopmental disorders in the development of movement and posture, non-progressive, resulting in activity limitations, resulting from an injury to the developing brain. Children with CP who have problems in sensorimotor coordination due to decreased muscle strength and impaired sensory processing experience postural control problems. In hemiparetic CP, deterioration in the upper extremities affects children's daily living activities such as eating, dressing, undressing, combing hair, brushing teeth, self-care skills, functional independence, and quality of life. Since the trunk plays a very important role in postural control and extremity functions, providing trunk stability and thus effective use of the extremities is one of the important goals of physiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Being diagnosed with congenital spastic hemiparetic cerebral palsy,
2. To be between the ages of 4-18
3. To be at the level of I, II or III according to the Manual Ability Classification System
4. Having sufficient communication skills
5. The willingness of the family and the child to be included in the study

Exclusion Criteria:

1. The family's refusal to participate in the study
2. Botulinum toxin application to the upper extremity or having undergone upper extremity surgery in the last 6 months
3. Having behavioral and communication problems that hinder the practices to be carried out within the scope of the study
4. Having an epileptic seizure
Alpha Lipoic Acid and Insulin Resistance

Subjects will be screened with a 2 hour oral glucose tolerance test. After this screening visit, their insulin resistance will be measured. Subjects will then be given either alpha lipoic acid (antioxidant) or placebo for 6 weeks. The insulin resistance test will be repeated after the 6 weeks. We believe these studies will confirm the beneficial effect of alpha lipoic acid on insulin sensitivity.

We propose to perform a placebo-controlled study of Alpha Lipoic Acid (LA) administration in a cohort of non-obese, non-diabetic, insulin resistant subjects. The insulin sensitivity of 180 subjects will be initially estimated by measuring fasting glucose and insulin levels (homeostasis model assessment) and oral glucose tolerance test (OGTT). The 60 most insulin resistant subjects will then be randomized to 6 weeks of therapy with either 600 mg three times a day of LA or placebo. To quantitate the ALA-induced improvements, euglycemic hyperinsulinemic clamps to evaluate insulin sensitivity, OGTT using deuterated glucose to evaluate glycolytic glucose disposal, and muscle biopsies to evaluate insulin signaling pathways, will be performed before and after treatment. We believe these studies will (1) confirm the beneficial effect of CR-ALA on insulin sensitivity; (2) further our understanding of the molecular mechanisms of LA action; and (3) because these insulin resistant subjects are at risk for the development of type 2 diabetes, the Metabolic Syndrome, and coronary artery disease (CAD), a demonstration of the beneficial effects of LA on insulin action could ultimately have important public health consequences.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, not exercising regularly

Exclusion Criteria:

* Diabetes, Impaired glucose tolerance, Heart disease, Liver disease, HIV, abnormal TSH results, other abnormal lab values
A Prospective Non-interventional Study in Overactive Bladder (OAB) Patients Prescribed Betmiga® as Part of Routine Clinical Practice

A study to understand the impact of Betmiga® on patients quality of life, satisfaction with treatment, how long patients remain on treatment, patterns of healthcare resource utilisation, and safety as prescribed by the physicians in routine clinical practice.

Single arm, hybrid model study, observing patients on Betmiga under conditions of routine clinical practice, with some element of retrospective data collection 2 years prior to enrolment of the study

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with OAB symptoms at Visit 1 of this study. OAB is defined by the International Urogynecological Association (IUGA)/International Continence Society (ICS) 2010 joint report as urinary urgency, with or without urinary incontinence, usually with frequency and nocturia, with no proven infection or other obvious pathology.
* Patients whose physician has made the decision to prescribe Betmiga® as part of routine clinical practice and who are about to start treatment.

Exclusion Criteria:

* Patients who are currently taking Betmiga®.
* Contraindication(s) as per the Betmiga® Summary of Product Characteristics (SPC).
A Study to Assess the Clinical Profile of Patients in Spain With Moderate to Severe Psoriasis.

The purpose of this study is to assess the clinical profile of patients with moderate to severe psoriasis in Spain. The primary objective is to analyze the clinical profile of patients with moderate to severe psoriasis, as defined by a set of conditions (obesity, hypertension, diabetes, abnormal amounts of lipids in the blood, cardiovascular disease, etc.) and its correlation to the patients' quality of life. The secondary objectives are to describe the demographic characteristics and habits of the patient, to evaluate the clinical characteristics of the disease, and to describe the diagnostic and therapeutic procedures being used in standard clinical practice and the patients' expectations for these therapies.

This is an epidemiological, non-interventional, multi-centre, cross-sectional, retrospective, observational study to assess the clinical profile of patients with moderate to severe psoriasis in Spain. The data for each patient will be recorded only once, in one visit. During this visit the specialist will ask the patient a series of questions to describe the existence or absence of a number of conditions and their associated treatments, to record the characteristics of psoriasis experienced by the patient and the type of associated treatment. Not applicable

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Diagnosed with psoriasis at least 6 months before the visit
* Diagnosed with moderate to severe psoriasis
* Who have been treated or not for moderate to severe psoriasis
* For whom the medical history dating back at least 6 months can be accessed
* the patient's legal representative has signed informed consent, stating that the patient understands the study purpose and requirements and grants the patient consent to participate in the study

Exclusion Criteria:

* Patient diagnosed with mild psoriasis according to the dermatologist or with a skin disease other than psoriasis
* With any type of difficulty understanding the questions in the DLQI, SF-36 and PBI questionnaires
* Who and/or whose legal representative refuses to grant written, informed consent to participate in the study