cyrilzakka/clinical-trials huggingface dataset:
Development of a Novel Human In Vitro Sarcoidosis Model

There is currently no experimental model that accurately represents sarcoidosis. The lack of a useful research model significantly slows progress towards developing new treatments for sarcoidosis. The investigators plan to develop a new model for sarcoidosis research and will test the model to see if it helps us understand how sarcoidosis develops and if it is useful for testing new treatments.

Sarcoidosis is a systemic granulomatous disease of unknown cause, most commonly affecting the lungs, which tends to afflict young adults in the prime of their lives. Recent data indicating that sarcoidosis mortality rates are rising in the U.S. (1) and Europe (2) highlight the inadequacy of current therapies. As noted in a recent NIH-sponsored sarcoidosis workshop, the lack of relevant animal, computer or in vitro models represents a bottleneck for progress towards understanding disease mechanisms and developing highly effective sarcoidosis treatments (3). The lack of useful disease models likely contributes to the current lack (zero) of investigator-initiated (RO1) projects supporting sarcoidosis research.

The long-term goal of this proposal is to develop a novel human sarcoidosis research model to fill the current void in the field, thereby expediting exploration of basic disease mechanisms and pre-clinical testing of novel therapies. The objective of this application, which is the first step towards achieving the long-term goal, is to develop a novel in vitro human granuloma model to represent abnormal granuloma formation in the context of sarcoidosis. In this regard, a growing body of evidence indicates that mycobacterial antigens are commonly harbored in sarcoidosis tissues, to which these patients are sensitized (4, 5). Our central hypothesis is that the pathological mechanisms of sarcoidosis can be modeled in vitro, as represented by abnormal granuloma formation in response to mycobacterial and other ubiquitous environmental antigens. The feasibility of our proposed model is supported by preliminary studies showing that subjects sensitized to Mycobacterium tuberculosis antigens (latent TB tuberculosis with a positive TB skin test) form well-organized granulomas readily in response to challenge with TB antigens, compared to healthy controls. This project is highly innovative and we feel has an excellent likelihood of leading to a critical breakthrough in the field of sarcoidosis research.

Eligibility Criteria:
Inclusion Criteria:

* sarcoidosis, subjects (18 - 45 years of age), including 30 sarcoidosis, 15 latent TB and 15 healthy controls.

Exclusion Criteria:

* pregnant women
Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery

The purposes of this study are:

1. To determine the efficacy of inter pleural analgesia
2. To determine the plasmatic concentration of ropivacaine by inter pleural road


Eligibility Criteria:
Inclusion Criteria:

* Thoracotomy for oncology thoracic surgery
* Secondary or primary cancer
* American Society of Anesthesiology (ASA) class 1 or 2

Exclusion Criteria:

* Ropivacaine hypersensibility
* Psychiatric disorders
* Incapacity of using visual analog scale
Efficacy of Repeated Transcranial Magnetic Stimulation Based on Near-infrared Imaging in Patients With Post-stroke Depression

This is a randomized controlled trial to evaluate the efficacy and safety of Low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) in post-stroke depression (PSD), explore mechanism of rTMS with Functional near-infrared spectroscopy (fNIRS).

To evaluate the efficacy and safety of low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) for the right dorsolateral prefrontal cortex (DLPFC) in patients with post-stroke depression (PSD), and explore the possible neural mechanism of rTMS with Functional near-infrared spectroscopy (fNIRS).

Patients were randomly assigned to the rTMS and control groups. the treatment effect was assessed by the Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), National Institutes of Health Stroke Scale (NIHSS), and Barthel Index (BI). Meanwhile, fNIRS was used to detect the changes of blood oxygen concentration in the frontal cortex.

After treatment, the score of the HAMD scale in the rTMS group decreased more significantly than in the control group (P\<0.05). The value of CH17 oxyhemoglobin (HBO) and the value of CH6 deoxyhemoglobin (HBR) were decreased after rTMS. The HbR of CH6 and CH8 decreased significantly, the HbR of CH12 and CH15 increased significantly (P\<0.05). The HAMA, NIHSS and Barthel scores improved more significantly in the rTMS group.

Eligibility Criteria:
Inclusion Criteria:

* 1) Hospitalized patients over 18 years of age; (2) Meet the stroke diagnostic criteria of the Fourth National Conference on Cerebrovascular Diseases and have been confirmed as ischemic or hemorrhagic stroke by head CT and MRI; (3) Symptoms of PSD such as low mood, loss of interest in daily life, insomnia, or poor appetite persist for more than 1 week and meet the inclusion criteria of the DSM-5; (4) Hamilton Depression Scale score-17 (HAMD) \> 7; (5) Stable vital signs, willing to accept the treatment method of this study, and sign the informed consent for treatment.

Exclusion Criteria:

* (1) Patients with a history of mental disorders and depression before stroke onset; (2) Patients with consciousness disorder, severe aphasia or comprehension and expression disorder after stroke; (3) Patients with serious cognitive impairment can not cooperate with the psychological evaluator; (4) Patients with metal implants in the skull; (5) People with cardiac pacemakers; (6) Previous head trauma, alcoholism, or family history of epilepsy and another risk of seizures; (7) psychotic symptoms such as agitation, speech and behavior disorder; (8) refuse to sign the informed consent.
Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.

Difficult cannulation of the common bile duct is encountered in about 10%of ERCP procedures. This frequently happens in the form of repeated unintentional cannulation of the pancreatic duct. Two valid options are available to facilitate cannulation at this point: Double guidewire technique or performing a transpancreatic precut. This is a randomized trial comparing the efficacy and Safety of double guidwire technique versus transpancreatic precut after three unintentional passages of the guidewire into the pancreatic duct.


Eligibility Criteria:
Inclusion Criteria:

* unintentional cannulation of the pancreatic duct 3 times
* Consenting to join the study

Exclusion Criteria:

* Previous ERCP with or without previous sphincterotomy
* Known coagulopathy

  * - Pregnancy
  * - Known acute pancreatitis at the time of procedure
Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma

This is a Phase I trial to look at safety and how a patient's body will tolerate the treatment at different dosages.


Eligibility Criteria:
Inclusion Criteria:

* CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease
Live Better at Home in Catalonia

The intensity of the home care interventions for dependent older people offered in Spain, and specifically in Catalonia, may not be sufficient to help keep older people at home and delay institutionalisation in a nursing home, but an intensification of the intervention could improve the health and psychosocial state of dependent people and their informal caregivers and facilitate their permanence at home.

According to recent surveys, more than 80% of older people prefer to live at home, so the current model of care should aim to prolong the autonomy of older people so that they remain as long as possible at home and delay their entry into nursing homes.

The hypothesis of the study is that an intensification of the home care intervention in users with degree II or III of dependency will delay or avoid their institutionalisation in nursing homes.

The main aim of the study is to evaluate the effect of an intensification in home care interventions on users with grade II or III dependency in order to delay or avoid their institutionalisation in a geriatric residence.

Secondary aims are to analyse the effect of an intensification of home care interventions in users with degree II or III of dependency on their health and psychosocial state.To analyse the effect of an intensification of home care intervention together with training for informal caregivers on the health status and overburden of informal caregivers of users with degree II or III of dependency.

To test the impact on the use of resources of an intensification of home care interventions in users with degree II or III of dependency.

A randomised clinical trial with two parallel arms and blinded assessment will be conducted. The duration of follow-up will be 18 months. It will be carried out at the community level in homes in eight municipalities in the province of Barcelona, Catalonia (Spain).

Eligibility Criteria:
Inclusion Criteria:

* Older people (men and women aged 65 and over).
* Living in the community.
* Categorized with a degree II or III of dependency.
* Users of the public home care without requesting admission to an institution in Catalonia.
* With a main informal caregiver in charge.
* The acceptance to participate in the study of the user and the informal caregiver.

Exclusion Criteria:

* Users with privately paid professional carers.
* Users in palliative care (short life expectancy).
Study to Investigate Genetic Causes of Severe Early Childhood Onset Obesity.

This study aims to investigate genetic causes of early childhood obesity.

The investigators will enroll children and adults with severe early onset obesity (BMI \> 99th percentile) diagnosed prior to 6 years of age. The investigators will ask questions about the health and eating behavior of the participants, and perform a brief physical examination. The investigators will collect saliva or blood to perform genetic testing from the participants and invite family members to enroll in the study.

This is a clinical and genomic study designed to investigate monogenic causes of severe early childhood obesity.

Participants with severe early onset obesity will be identified by screening of the clinical database or referred for the study. These subjects will be invited to participate in the study. After obtaining informed consent, the investigators will obtain history on the proband and the family, and perform a brief examination in addition to collecting genetic material.

Targeted sequencing of genes associated with monogenic and syndromic forms of obesity will be performed using next-generation sequencing. In selected individuals with favorable family history, exome or whole genome sequencing will be performed. Functional analysis of newly identified variants will be performed where possible.

Eligibility Criteria:
Inclusion Criteria:

- BMI \> 99th percentile documented at age \< 6 years of age

Exclusion Criteria:

* Known genetic causes of obesity
* Known Endocrine causes of obesity.
* Neurologic tumor, trauma or surgery
* Prior malignancy or transplant
* Known autoimmune diseases
* Edema of a known or unknown cause
* Prolonged steroid use.
Sacubitril/Valsartan for CKD5 Stage Dialysis Patients

Hemodialysis or peritoneal dialysis CKD5 patients were randomly divided into Sacubitril/Valsartan and irbesartan treatment groups. Comparing the blood pressure, survival rates, the cardiac function, renal function,and adverse reactions of two groups, to evaluate whether the efficacy and safety of Sacubitril/Valsartan in the treatment of patients with CKD dialysis combined with heart failure is superior to that of irbesartan.


Eligibility Criteria:
Inclusion Criteria:

* CKD stage 5, starting regular hemodialysis or peritoneal dialysis for more than 1 month.
* NT-proBNP ≥2000pg/ml.
* hypertension
* Voluntary informed consent.

Exclusion Criteria:

* Unable to tolerate ACEI/ARB class antihypertensive drugs;
* History of symptomatic hypotension/systolic blood pressure \<100mmHg at screening;
* Potassium \>6.0mmol/L;
* History of angioedema;
* Abnormal liver function such as ALT and/or AST \>=3 times normal upper limit (ULN), total bilirubin \>= 2 times ULN;
* Moderate to severe anemia (hemoglobin \<80g/L);
* Cardiac surgery/intervention/cardiac resynchronization therapy has been performed in the past 3 months or is planned in the next 12 months;
* Newly found malignant tumor (within 3 years), or undergoing radiotherapy/chemotherapy;
* Pregnant and lactating women, or those of childbearing age who are unable to guarantee effective contraception;
* New and serious life-threatening infections;
* Active infectious diseases such as active tuberculosis, active viral hepatitis and HIV infection;
* Persons suffering from mental disorders and taking psychotropic drugs;
* Patients with life expectancy less than 12 months;
* The doctor assessed that the patient was not easy to follow up or had poor compliance and was not suitable for enrollment;
* Patients who do not want to sign informed consent.
Trial of Vitamin D to Reduce Risk and Severity of COVID-19 and Other Acute Respiratory Infections

CORONAVIT is an open-label, phase 3, randomised clinical trial testing whether implementation of a test-and-treat approach to correction of sub-optimal vitamin D status results in reduced risk and/or severity of COVID-19 and other acute respiratory infections.


Eligibility Criteria:
Inclusion criteria:

1. UK resident
2. Age ≥16 years
3. Gives informed consent to participate

Exclusion criteria:

1. taking digoxin, alfacalcidol, calcitriol, dihydrotachysterol or paricalcitol
2. known diagnosis of sarcoidosis, primary hyperparathyroidism, renal stones or renal failure requiring dialysis
3. known allergy to any ingredient in the study capsules (vitamin D, olive oil, caramel, gelatine or glycerol)
4. pregnancy
Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age and no more than 39 years of age
* Existing soft contact lens wearers
* Willing to signed a written Informed Consent.
* Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day.
* Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes.
* Have an Astigmatism of 1.00D or less in both eyes.
* Require a visual correction in both eyes.
* Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.
* Have normal eyes with no evidence of abnormality or disease that would preclude lens wear.

Exclusion Criteria:

* Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Clinically significant corneal staining (Grade 3 in more than one region).
* Keratoconus or other corneal irregularity.
* Abnormal lachrymal secretions.
* Extended wear of contact lenses last 3 months.
* Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
* Refractive surgery.
* Eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Require concurrent ocular medication
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Any infectious disease (e.g., hepatitis, tuberculosis) or any immunosuppressive disease (e.g., HIV).
* Diabetes.
* Pregnant, lactating or planning a pregnancy at the time of enrollment.
* Participation in any concurrent clinical trial or in last 30 days.
Advancing Postmenopausal Preventive Therapy

Advancing Postmenopausal Preventive Therapy (APPT) is a randomized, double-blinded, placebo-controlled trial designed to determine the effects of tissue selective estrogen complex (TSEC) therapy on the progression of subclinical atherosclerosis and cognitive decline in 360 healthy postmenopausal women.

To conduct a double-blinded, placebo-controlled trial to determine the effects of TSEC therapy on the progression of subclinical atherosclerosis in healthy postmenopausal women. A total of 360 postmenopausal women with a uterus who are within 6 years of menopause and 45-59 years of age and without clinical cardiovascular disease and diabetes mellitus will be randomized to Bazedoxifene/Conjugated Equine Estrogen (BZA 20 mg/CE 0.45 mg) or placebo. Recruitment will occur over 3 years and the treatment period will be up to 3 years depending on when an individual is randomized. Rate of change in carotid artery intima-media thickness (CIMT) determined from the distal common carotid artery (CCA) far wall intima-media thickness (IMT) in computer image processed B mode ultrasonograms will be the primary trial endpoint. Arterial stiffness measured from the CCA (same location as CIMT) in computer image processed B mode ultrasonograms will be the secondary trial endpoint. Three composite cognitive measures will be used to test for randomized treatment group differences in cognition; each composite will be considered as co-endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Women with a serum estradiol level \<30 pg/ml and cessation of regular menses \>6 months who are \<6 years postmenopausal and 45-59 years old.

Exclusion Criteria:

* Women with a hysterectomy
* Clinical signs, symptoms or personal history of cardiovascular disease
* Diabetes mellitus or fasting serum glucose \>126 mg/dL
* Life threatening illness with prognosis \<5 years
* Cirrhosis or liver disease
* History of deep vein thrombosis or pulmonary embolism
* History of breast cancer
* Current use of postmenopausal hormone replacement therapy (HRT) within 1 month of randomization
* Uncontrolled hypertension (\>180/\>110 mmHg)\*
* Plasma triglyceride levels \>500 mg/dL
* Serum creatinine \>2.0 mg/dL
Initial Experience of Transabdominal Fetal Reduction in Nepal

Multifetal pregnancies are common in in vitro fertilization. Multifetal gestation increases maternal and fetal morbidity and mortality. We perform fetal reduction in our hospital by intra-thoracic injection of potassium chloride. This manuscript is description of our initial experience.

Assisted reproductive technology and stimulated conception have led to an increase in the prevalence of high order multifetal pregnancies (MFPs) in recent times. MFPs are associated with high maternal and fetal complications. Fetal mortality and morbidity are due to complications of prematurity. Prevalence of pregnancy induced hypertension, pre-eclampsia, eclampsia, antepartum hemorrhage, post-partum hemorrhage, gestational diabetes and difficult deliveries are more in mother with MFP. Embryo/Fetal reduction in high order MFPs helps in prolongation of gestation. Multifetal pregnancy reduction (MFPR) is secondary prevention of the risks associated with MFP. Trans-abdominal intracardiac injection of KCl is a simple, safe and effective technique for MFPR. We are among the first few centers in Nepal doing MFPR. In this study, we are sharing our initial experience of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* pregnant females with multifetal gestation who opt to undergo fetal reduction

Exclusion Criteria:

* who do not give consent
NanOss Bioactive With Autograft and Bone Marrow Aspirate in the Posterolateral Spine

The purpose of this study is to assess lumbar fusion using nanOss Bioactive bone void filler


Eligibility Criteria:
Inclusion Criteria:

1. Is at least 21 years of age and skeletally mature.
2. Must have cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one level in the cervical spine between C3 to T1.
3. Must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment.
4. Has pre-operative objective evidence of primary diagnosis confirmed by appropriate imaging studies (Anteroposterior/Lateral/Flexion/Extension X-rays \& a recent MRI).
5. Is willing and able to comply with all clinical investigation visits and procedures including screening treatment procedures, post-operative management, the follow-up schedule and completion of forms or questionnaires.
6. Is able to understand and sign the patient information sheet/informed consent form.

Exclusion Criteria:

1. Requires fusion at more than one level.
2. Has had prior fusion at the level to be treated.
3. Has a metabolic or systemic bone disorder.
4. Has a disease that significantly inhibits bone healing (i.e., severe osteoporosis, osteomalacia, Paget's disease).
5. Has a systemic or local infection (active or latent).
6. Has acute or chronic infections in the surgical area (i.e., soft tissue infections; inflammatory, bacterial bone disorders, osteomyelitis).
7. Chronic use of steroids, other than episodic use or inhaled corticosteroids.
8. Has any significant general illness (i.e., HIV, active metastatic cancer of any type, uncontrolled diabetes Type I, dialysis dependent renal failure, symptomatic liver disease).
9. Has a mental or physical condition that would limit the ability to comply with study requirements or would preclude accurate evaluation.
10. Is immunocompromised or being treated with immunosuppressive agents (including chemotherapy or radiation treatment).
11. Has documented allergies to hydroxyapatite or porcine collagen, PEEK, titanium, titanium alloy or tantalum.
12. Is currently pregnant, or interested in becoming pregnant during the clinical investigation follow-up.
13. Is a smoker.
14. Is non-English speaking.
15. Requires the use of a bone-growth stimulator.
16. Is a prisoner.
17. Is currently involved in another drug or device clinical investigation that may confound the clinical trial investigation