cyrilzakka/clinical-trials huggingface dataset:
Indicated Prevention of Psychotic Disorders With Low-dose Lithium

This study investigates the neuroprotective properties of low-dose lithium in young individuals at ultra-high risk of developping a first psychotic episode. Fourty individuals having some symptoms of an emerging psychotic disorders (without meeting the threshold for a full-blown mental illness) will be treated with a low dose of lithium (about a third of the dose that is usually used to treat acute mania). We will assess the progression of the conditions of these individuals on a montly bases for a year. We will do behavioural, cognitive and imaging assessments prior start of the treatment, after three months and one year. We hope to demonstrate that low dose lithium will stop or even reverse the progression of disease. We expect that behavioral, cognitive and in vivo brain imaging parameters in those individuals treated with low dose lithium improve, compared to the monitoring group.

To investigate whether low-dose lithium is an effective agent in indicated prevention amongst subjects at ultra-high risk of developing a psychotic disorder. This aim will be achieved by treating a high-risk patient population with low-dose lithium (450mg/day) and investigating its effects using clinical, neuropsychological, neuroimaging and cell biological approaches. We will recruit 30 patients considered to be at ultra-high risk of developing a first psychotic episode, currently receiving treatment at the Personal Assessment and Crisis Evaluation (PACE) clinic in Melbourne, Australia. PACE criteria for identifying patients at high risk include subjects with a family history of psychosis and a decrease in functioning (30% GAF) AND/OR attenuated psychotic symptoms AND/OR brief psychotic symptoms (BLIPS) resolving without treatment. Patients who give informed consent will receive treatment with a slow release form of low dose lithium for a period of a year, plus supportive therapy. Patients who do not consent will receive supportive therapy only. Assessments will be conducted at baseline, twelve weeks and one year post-recruitment. Assessments will include cognitive functioning, structural MRI, 1H-MRS at 3Tesla and cell biological parameters (bcl-2, AP-1; NIMH, Washington DC). In addition, all patients will be seen on a monthly basis for a clinical interview, covering psychopathology, global functioning, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Attenuated psychotic symptoms
* Self-limited brief psychotic episode
* Family History of psychosis and decrease in functioning over last year

Exclusion Criteria:

* Organic causes of subthreshold psychotic symptoms (eg. epilepsy)
* More than one week of neuroleptic treatment
The Effectiveness of the Water Jet Device in Removing Dental Plaque Around Orthodontic Braces in Adolescents

The aim of this study was to evaluate the effectiveness of the water jet in removing dental plaque around the orthodontic braces in adolescents.

The aim of this randomized controlled trial was to evaluate the effectiveness of the water jet in removing dental plaque around the orthodontic braces compared to manual toothbrush in adolescents. The null hypothesis was that no significant difference would be noted between the Water Jet and manual toothbrush in removing dental plaque around the orthodontic braces. Such studies provide another dental care tools for maintaining oral hygiene among orthodontic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy children.
2. Children aged 11 to 15 years.
3. Children who did not receive any fluoride treatment in the dental clinic.
4. Patients who had orthodontic braces at least on the anterior segment of the upper and lower jaws.

Exclusion Criteria:

1. Special Health Care Needs (SHCN) patients.
Pivotal Study for Validation of Philips Dx (PDx)

The primary objective of this study is to show safety and effectiveness of the PDx for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.


Eligibility Criteria:
Inclusion Criteria

* All relevant coverslipped slide or slides, with human tissue obtained via surgical pathology of original case are available.
* Original sign-out diagnosis is available.
* The selected slide or slides fulfill the quality checks according to general clinical practice.
* Target enrollment of organs and subtypes according pre-specified list.

Exclusion Criteria

* Cases, including sent out cases, for which any of the relevant slides used for the original sign-out diagnosis is no longer available at the site.
* The selected slide or slides do not match any subtype of the organ for which the case was selected.
* Relevant Clinical Information that was available to the sign-out pathologist in the pathology request form cannot be obtained.
* Selected slides contain indelible markings.
* Selected slides with damaged tissue.
* More than one case was selected for a patient (only one case may be enrolled per patient).
* Case consists of frozen section(s) only.
* Case consists of gross specimens only.
Enoxaparin Dosing in Obesity

The purpose of this study is to determine an effective enoxaparin dosing strategy in medically ill, morbidly obese patients. This study will include adult patients greater than 18 yrs of age being admitted to Grady Hospital in Atlanta, GA. Potentially vulnerable patients such as prisoners, children, and pregnant women will not be enrolled in the study. Study participants will be contacted in person by the study personnel once inclusion criteria are met. Written informed consent will be obtained in person while hospitalized. Once the patient is consented they will be given enoxaparin and blood samples will be drawn. The data collected will be from the electronic medical record which is accessed only with a username and password so it is not publicly available. The data will be identifiable upon collection and will be kept on a password protected file on a computer in a locked office. The data will be de-identified after data analysis and only the study personnel will have access to the code that links identifiers to subjects. A HIPAA waiver will be requested to access existing data in order to identify patients for enrollment. All data will be collected in an office in the hospital. The study participants' burden will be minimal and dependent only on time of consent process since morbidly obese patients would be receiving this blood sample collection regardless of their participation in the study.


Eligibility Criteria:
Inclusion Criteria:

* Planned treating with twice daily enoxaparin
* BMI \>= 40 kg/m2

Exclusion Criteria:

* \< 18 years of age
* CrCl \< 30 ml/min
* Pregnancy
* Prisoner
* Active bleeding
* Already received 3 consecutive doses of enoxaparin
* Use of therapeutic enoxaparin for more than 5 consecutive days within the last 3 months
Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)

PRIMARY OBJECTIVES

Two co-primary objectives are:

* To demonstrate that the immunogenicity of ZOSTAVAX administered by intramuscular route (IM) is non-inferior to ZOSTAVAX administered by subcutaneous route (SC)
* To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of varicella zoster virus (VZV) antibody titre from pre to 4-week post-vaccination

SECONDARY OBJECTIVES

Immunogenicity objectives

* To evaluate the immunogenicity as measured by VZV antibody titre at 4 weeks following ZOSTAVAX administered by IM or SC route
* To evaluate the immune response as measured by a second assay, the VZV Interferon gamma Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or SC route

Safety objective

- To describe the safety profile of ZOSTAVAX administered by IM or SC route


Eligibility Criteria:
Inclusion Criteria:

* Adults aged \>=50 years
* Varicella history-positive or residence for \>30 years in a country with endemic VZV infection

Exclusion Criteria:

* Febrile illness
* History of hypersensitivity or anaphylactoid reaction to any of the vaccine components
* Prior herpes zoster episode clinically diagnosed or exposure to varicella or herpes zoster within the 4 weeks prior to vaccination
* Prior receipt of varicella or zoster vaccine
* Active untreated tuberculosis
* Thrombocytopenia, any other coagulation disorder contraindicating intramuscular injection
* Receipt of medication / vaccine that may interfere with study assessments
* Known or suspected immune dysfunction
* User of recreational / illicit drugs or subject with alcohol abuse or dependence within the last year
* Any condition that might interfere with the interpretation of the study,
Biomarker Guided Intervention for Prevention of Acute Kidney Injury

This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients. Eligible patients are screened for marker of tubular stress in the urine; if patient specific results are above a pre-defined cutoff they are randomized into a standard care group or an interventional group in which patients receive intensified volume therapy.

This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients.Used markers have been identified as markers of tubular stress and have been validated in previous studies with more than 1500 patients. The advantage of a biomarker guided approach is the saving of time for the diagnosis a developing acute kidney injury (AKI) in high risk surgical patients, since clinical signs of AKI (rise in creatinine/decline of estimated Glomerular Filtration Rate (eGFR), decline of diuresis). If used biomarkers are above a predefined cutoff within \< 4 hours after surgery, patients are randomized in to a standard care population receiving treatment in accordance with Kidney Disease Improving Global Outcomes (KDIGO) guidelines. In the intervention population patients receive individual volume therapy (= balanced electrolyte solution (Ionosteril)) (1,25 ml/kg bw up to 5 ml/kg bw for 6 hours). Degree of volume therapy is estimated by several predifined parameters, e.g. central venous pressure (CVP).

Eligibility Criteria:
"Inclusion Criteria":

* major surgery with a duration \> 4 hours plus one of the following criteria:
* age \> 75 years, or
* sepsis, or
* shock, or
* polytrauma, or
* need for invasive ventilation or catecholamines, or
* intra-operative application of contrast-medium, or
* preexisting chronic kidney disease (CKD1-4),
* informed consent

Exclusion Criteria:

* age \< 18 years,
* end stage renal disease (ESRD),
* preexisting dialysis,
* withdrawal of consent,
* pregnancy,
* breastfeeding
Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

This study is to evaluate the efficacy and safety of compound danshen dripping pills in preventing and treating acute mountain sickness.

Compound danshen dripping pills is mainly used for the treatment and prevention of coronary heart disease and high-risk groups ,consists of Danshen (Radix Salviae Miltiorrhizae), Sanqi (Radix Notoginseng) and borneol.Danshen is the main drug efficacy of stasis, nourishing the nerves.Pharmacological studies have shown that Danshen can improve the oxygen carrying capacity of blood, increase oxygen supply to vital organs, effectively reduce hypoxia-induced heart and other vital organs, brain and kidney damage. Danshen can activate the fibrinolytic system, reduce blood viscosity, clear the microcirculation, promote blood circulation, increasing the amount of tissue oxygen by inhibiting platelet aggregation.This study is being conducted to evaluate the efficacy and safety of compound danshen dripping pills in preventing and treating acute mountain sickness, when compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-45 years，Male or female, plain natives
* first stationed at high altitude above 3,000 meters
* Upon physical examination before enrollment in good health
* BMI 19 to 24; (weight kg / height Sqm )
* voluntary signs the informed consent

Exclusion Criteria:

* menstruation, pregnancy and breast-feeding women
* smoking, alcohol and drug abusers
* Clear history of drug allergy or allergic persons
* application of various drugs (including traditional Chinese medicine) two weeks ago
* Combined with severe liver and kidney dysfunction (cardiac function Grade ≥3, liver function Grade \> 2 times of the upper limit of normal, Cr\> upper limit of normal);
* Subject with blood donation experiences or blood test experiences within three months before be selected.
* C- reactive protein test results exceed the upper limit of normal.
* clinically significant gastrointestinal disease, mental illness and diabetes, hyperthyroidism and other metabolic diseases;
* Past suffering from cardiovascular and cerebrovascular disease
* fatigue syndrome that is not by high altitude-induced
* primary headache
* Vomiting due to other causes, such as digestive disorders as a result of the vomiting reflex, vomiting vestibular disorders, neurotic vomiting;
* Allergies
* Who participated in clinical trials of other drugs within a month
* blood circulation, increase immunity and antioxidant drug users
Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma

The purpose of this international multi-center double-blind randomized placebo-controlled trial is to determine the effect of nebulized heparin, compared to placebo, on the number of ventilator-free days at day 28, in burn patients with confirmed inhalation trauma requiring mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age \> 18 years
* Need for invasive mechanical ventilation
* Confirmed inhalation trauma (bronchoscopically)

Exclusion Criteria:

* \> 36 hours after trauma
* Receiving invasive ventilation \> 24 hours
* Expected duration of mechanical ventilation \< 24 hours
* Chronic obstructive pulmonary disease GOLD stage III and IV
* Any history of pulmonary hemorrhage in the past 3 months
* Any history of significant bleeding disorder
* Known allergy to heparin, including heparin-induced thrombocytopenia
* Pregnancy or breast feeding
* Unlikely to survive for \> 72 hours
* Total body surface area (TBSA) \> 60%
* Witnessed or proven aspiration (i.e., confirmed by bronchoscopy)
National Study of Adrenal Tumours

This is a study putting together large numbers of patients with or without a hereditary risk of adrenal tumours including tumours such as adrenocortical carcinoma and phaeochromocytoma/paraganglioma. The purpose is to answer questions about the survival of patients with these rare tumours and to do this, we will collect information on diagnosis and management of these tumours. This data will be best assessed by combing these rare cases at a national level recruiting from centres throughout UK and Ireland. The information will be confidential and stored in a secure platform.

Patients will be approached for consent to gather their data by their local consultants and patients will have the choice to participate or decline participation, which will not affect their standard of care treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a confirmed diagnosis of phaeochromocytoma or paraganglioma or adrenocortical tumour based on histology and or biochemical testing including plasma or urine metanephrine's or a urine steroid profile and confirmatory imaging tests or patients with a confirmed pathogenic variant in a known PPGL predisposition gene
2. Patient is willing and able to give informed consent for the participation in the study.
3. Male or female, and over the age of 18.
4. Patient, in the investigator's opinion, is able and willing to comply with all the study requirements.
5. Patients held on local hospital audit notes who have had a diagnosis of phaeochromocytoma or paraganglioma or adrenocortical tumour based on histology and or biochemical testing including plasma or urine metanephrine's or a urine steroid profile and confirmatory imaging tests or patients with a confirmed pathogenic variant in a known PPGL predisposition gene who are now deceased and have been deceased prior to the start of the study.

Exclusion Criteria:

1. Alive patients unable to give informed consent will not be recruited
2. Patients with an unconfirmed diagnosis of phaeochromocytoma or paraganglioma or adrenocortical tumour based on histology and or biochemical testing including plasma or urine metanephrine's or a urine steroid profile and confirmatory imaging tests or patients with unconfirmed pathogenic variant in a known PPGL predisposition gene
Efficacy and Analgesic Use During the Therapy of Iatrogenic Pneumothorax Using Pleuralvent™ and Chest Tube

The aim of this clinical trial is to compare the efficiency and analgesic use in the therapy of iatrogenic Pneumothorax when using the Pleuralvent™ system in comparison with large bore chest tubes (catheter 16F).

Rationale:

Pneumothorax is a common, usually invasively treated, disorder. The usual methods of treatment are needle aspiration (14-16 G needles) or chest drainage (16+ F catheters).

A third therapeutic option is the use of small calibre catheters (\< 16F). According to some studies, the success rates of these methods are comparable. These catheters have the same success rate as large bore chest tubes and treatment with them is less painful for patients.

The use of Heimlich valves allows for increased patient mobility - or even out-patient treatment.

According to a review by the European Respiratory Society, nowadays there is an availability of systems which are part of advanced intervention techniques. These devices are designed for ease of insertion allowing for the full mobility of patients. It is, however, not clear whether treatment with these new systems is less painful.

The aim of this clinical trial is to compare the efficiency and analgesic use in the therapy of iatrogenic Pneumothorax when using the Pleuralvent™ system in comparison with large bore chest tubes (catheter 16F).

Process:

Following the completion of the initial screening (fulfilling of both inclusion and exclusion criteria) and the signing of informed consent, a patient with iatrogenic pneumothorax (PNO) will be treated with, according to randomisation, either the Pleuralvent™ system or with a large bore chest tube - 16F. A control chest X-ray will be performed immediately after the introduction of the therapeutic method and following 3 days of therapy.

If no signs of PNO are present, the therapy will be terminated. In cases where the lung will not be completely expanded, the control X-ray will be repeated on the 5th, 7th and 10th day of therapy. If, following this, the PNO will persist without resolution, the therapy will be declared non-effective and other therapy modes will be used (conversion to large bore chest drainage in the Pleuralvent™group and surgical treatment in the chest drainage group).

Eligibility Criteria:
Inclusion Criteria:

* Iatrogenic pneumothorax indicated for invasive therapy

Exclusion Criteria:

* Chronic analgesic therapy
* Contraindications for Pleuralvent™ use
* Non-compliance of patients
* Clinically significant hepatopathy (alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 3 times normal values)
* Clinically significant renal insufficiency (glomerular filtration \< 0.5 ml/kg/min)
* Allergy to metamizole/tramadol
Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions

To evaluate for any adverse effects that may be related to the administration and reception of autologous adipose derived stromal vascular fraction (SVF). Secondarily, the study monitors the results of subjective and objective findings as it applies to the non-blinded deployment of autologous SVF for various inflammatory and/or degenerative conditions including select orthopedic, neurologic, urologic and cardio-pulmonary conditions. SVF deployments include intra-venous, intra-articular, and soft tissue injections.

SVF Stromal Vascular Fraction is obtained by lipoharvesting, procurement, and lipo-transfer as a same day operative procedure

Eligibility Criteria:
Inclusion Criteria

* Patient must be age 16 or older
* Patient must have a degenerative disease or inflammatory disease that meets criteria for treatment under the IRB which includes: Arthritis, Auto-immune disease,COPD, Cardiomyopathy, Peyronies Disease,Interstitial Cystitis, Erectile Dysfunction, and Neurodegenerative disease such as Parkinsons, ALS, Neuropathy.
* Patient must be healthy enough to tolerate a local anesthetic

Exclusion Criteria:

* Patient must not have active cancer
* Patient must not have active infection
Treatment Options for Chronic Urticaria

chronic urticaria is one of the most common dermatological disease affecting many people, exploring most treatment options for its treatment is need of an hour.

Our study aim to compare the efficacy of Autologous Serum Therapy (AST) with levocetirizine in Chronic Urticaria patients

Urticaria is one of the most common skin diseases causing redness, and swelling in the dermis and epidermal layers and are severely pruritic.

Chronic urticaria is further sub-divided into chronic spontaneous urticaria and chronic inducible urticaria. International guidelines recommend non-sedating antihistamines once daily as first-line therapy for chronic spontaneous urticaria and chronic inducible urticaria.

Levocetirizine which is classified as a second-generation antihistamine and works by blocking histamine H1-receptors , is an effective treatment for CIU, characterized not only by a rapid and sustained response, but also by an important improvement in QOL.

Autologous serum therapy (AST) has been tried by many in patients with CAU with variable results, majority showing beneficial effects. AST has also been used in the treatment of ocular alkali burn patients Presence of tolerance generating anti-idiotype antibodies to mast cell degranulating antigens that induce remission of the disease forms the basis of AST and this therapy has been tried in various autoimmune diseases Our study aim to compare the efficacy of Autologous Serum Therapy (AST) with levocetirizine in Chronic Urticaria patients OBJECTIVE "TO COMPARE THE EFFICACY OF AUTOLOGOUS SERUM THERAPY VS LEVOCETRIZINE IN THE TREATMENT OF CHRONIC URTICARIA IN TERTIARY CARE HOSPITAL"

DATA COLLECTION:

Data will be collected on prescribed proforma which is attached, at Dermatology OPD, Sheikh Zayed Hospital, Rahim Yar Khan. Patient will be selected on basis of inclusion \& exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will include 72 patients which will be divided into 2 groups, A \& B, 36 in each group. Group A will receive AST, Group B will receive oral levocetirizine 5mg 1 tablet HS.

5 ml of blood will be collected and centrifuged at 3000 RPM for 10 min to obtain serum,2 ml of the serum will be injected into the gluteus muscle. We will give the patients 9 injections of Autologous Serum intramuscularly once a week .

Follow up visit will be after 2 months of last session.

DATA ANALYSIS:

Data will be analyzed by SPSS v25.0

Eligibility Criteria:
Inclusion Criteria:

* Age: 13-60 years
* Gender: Both male and female
* Patients having urticaria for more than 6 weeks diagnosed clinically

Exclusion Criteria:

* Pregnancy and lactating females
* Patients who are immunosuppressed either due to medication or disease.
* Patients suffering from chronic diseases i-e chronic liver disease, chronic kidney disease.
* Patients taking steroids in last 2 weeks.