cyrilzakka/clinical-trials huggingface dataset:
Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus

This is a single blind placebo-controlled pilot study involving Systemic Lupus Erythematosus and lupus nephritis patients. We propose to recruit and consent SLE patients who will be randomized to either receive the study drug, an over the counter fish oil supplement, or a placebo that contains olive oil. They will have a baseline metabolomic profile (blood test), nutritional assessment, fatigue severity scale, quality of life assessment, and SELENA-SLEDAI lupus disease activity assessments completed at the time of study medication distribution. Once 6 months of either the study drug or placebo is completed, then pill counts, assessments of experience/adherence (including side-effects, adverse effects, complaints, and un-blinding), and repeat nutritional assessment, fatigue severity scale, SELENA-SLEDAI, and metabolomic profile will be assessed. The study duration for each patient will be 6 months from initiation of the study drug. It is hypothesized that patients receiving the fish oil supplement will have improvement in their metabolomic profile. Additionally it is hypothesized that patients receiving the fish oil supplement will have improvement in disease activity, fatigue, and quality of life assessments.

Supplementation with EPA and DHA could potentially reduce the inflammatory state of SLE patients. This study is a single blind placebo-controlled pilot for SLE patients with 25 scheduled to receive omega-3 (EPA 2.25g/DHA 2.25g) daily and 25 scheduled to receive placebo (olive oil), for 6 months. Pre and post supplementation assessments will be made to determine if EPA and DHA levels increase, and if the levels of lipid peroxidation products, other cellular energy intermediates, and inflammatory markers are affected by EPA/DHA. Additionally, lupus disease activity, fatigue, quality of life, and diet will be assessed to determine if these parameters are related to the metabolome in SLE.

* Aim 1:

  - To determine if the metabolomic disturbances of lupus patients improve following supplementation with omega-3 fatty acids.
* Aim 2:

  * To determine if lupus disease activity, fatigue, and quality of life improve and are related to the metabolomic profile changes.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* All ethnic groups
* Aged 18-64
* Biopsy proven diagnosis of Lupus Nephritis and/or fulfillment of 4 or more American College of Rheumatology criteria for the diagnosis of Systemic Lupus Erythematosus

Exclusion Criteria:

* Currently taking, or have taken in the last 2 months, fish oil/omega-3 fatty acid/DHA/EPA
* Allergic to fish oil, shellfish, or other fish products
* Pregnant
* Currently taking the medication: Tositumomab (Bexxar)
* Currently taking anti-coagulant medications (Abciximab, Acenocoumarol, Anisindione, Ardeparin, Argatroban, Bivalirudin, Certoparin, Cilostazol, Clopidogrel, Dalteparin, Danaparoid, Defibrotide, Dermatan Sulfate, Desirudin, Dicumarol, Enoxaparin, Eptifibatide, Fondaparinux, Heparin, Lamifiban, Nadroparin, Phenindione, Phenprocoumon, Reviparin, Sibrafiban, Tinzaparin,Tirofiban, Warfarin, Xemilofiban)
Endothelial Cell Loss After Cataract Surgery

The purpose of this study is to compare two cataract surgical technique variations for removing the nucleus of the lens (central part of the lens) in terms of damage to the inner layer of the cornea which is called the endothelium. One variation uses more ultrasound energy and the other more mechanical force to break up the nucleus.


Eligibility Criteria:
Inclusion Criteria:

* Visually significant moderate density cataract

Exclusion Criteria:

* Corneal or retinal pathology limiting visual potential to worse than 20/40
* Lens pathology including pseudoexfoliation or lens dislocation
* Prior intraocular surgery
* Age less than 40
A Study of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia

A Randomized Study of ALG-055009 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses in Healthy Volunteers and Subjects with Hyperlipidemia


Eligibility Criteria:
Inclusion Criteria for Healthy Subjects:

1. Male and Female between 18 and 55 years old
2. BMI 18.0 to 32.0 kg/m\^2

Inclusion Criteria for Subjects with Mild Hyperlipidemia:

1. Male and Female between 18 and 65 years old
2. BMI 18.0 to 35.0 kg/m\^2
3. Subject must be on a stable diet for the 3 months prior to screening with a fasting LDL-C level \>110 mg/dL at screening

Exclusion Criteria for All Subjects:

1. Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
2. Subjects with Hepatitis A, B, C or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
3. Subjects with renal dysfunction (e.g., estimated creatinine clearance \<90 mL/min/1.73 m\^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)
4. Subjects with history of thyroid disorder or abnormal thyroid function tests at screening or known sensitivity to thyroid medications
5. Subjects receiving, or urgently requiring, any lipid lowering therapy
Steroids, Hyaluronic Acid or Platelet Rich Plasma Versus Placebo for the Knee Osteoarthritis

This study investigates clinical outcome and imaging outcome parameters after intraarticular injection of steroids, platelet-rich-plasma (prp), hyaluronic acid or placebo in patients with early osteoarthritis of the knee joint.

Osteoarthritis of the knee joint is a very common disease in middle aged and elderly patients. This study evaluates the efficiency of different commonly used substances for intraarticular, non-operative treatment in early stages of this disease.

120 patients receive an fluoroscopic guided injection in the knee joint: 30 patients get injection with steroids 30 patients get injection with prp 30 patients get injection with hyaluronic acid 30 patients get injection with placebo (iopamiro contrast media)

Primary outcome: - clinical outcome (pain using numeric rating scale)

* Magnetic Resonance imaging (cartilage defects etc.)

Eligibility Criteria:
Inclusion criteria:

* gonarthritis Kellgren 1,2,3 with symptoms
* german speaking
* informed consent

Exclusion criteria:

-age under 18, gonarthritis, Kellgren 4, anticoagulation therapy, known inflammatory disease or infection, cardiovascular disease NYHA IV, immunosuppression, contraindication for MRI, pregnancy, no informed consent, NSAR 3 days before injection, etc.
French Registry of Acute Coronary Syndrome

The Fast-MI registry was designed to evaluate the "real world" management of patients with acute myocardial infarction (MI), and to assess their in-hospital, medium and long-term outcomes

Primary objectives : compare survival following the admission to a USIC according to the terms of care

Eligibility Criteria:
Inclusion Criteria:

* admission within the 48 hours after the occurence of acute myocardial infarction (AMI)
* written informed consent for the DNA and serum databank

Exclusion Criteria:

* AMI occured within the 48 hours after therapeutic intervention (bypass, coronary angioplasty or other chirurgical intervention)
* diagnostic of AMI not confirmed
COhort for Bardet-Bield Syndrome and Alström Syndrome for Translational Research Monocentric Interventional Study

ALMS and BBS syndromes are rare diseases with overlapping features of multiple sensory and metabolic impairments, including diabetes mellitus. There are to date no specific treatments available and limited information on the natural history of the diseases. the investigators aim to establish a French cohort for these diseases to improve patient care and assess the effect of actual therapies on quality of life.

The purpose of this study is to establish a cohort of Bardet-Bield syndrome (BBS) and ALström syndrome (ALMS) patients in order to formalize and address questions concerning the in-depth natural clinical and biological history of the disease on the long term for a given patient, establish the impact on the quality of life of various clinical manifestations


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sex
* Age minimum\*
* patients with social protection
* Written informed consent form signed prior initiating any trial related procedure:

  * by \> 18-year old patients
  * by both parents for minor patients \> 4 months or legal representative for protected adults, and by minor and protected adults patients if able to understand and/or give their assent.
  * For foreign patients, a third party will translate, if required, the information prior to the consent.
* a diagnosis of BBS or ALMS based on molecular assessment or clinical evaluation/or patient with mutation and none of the diagnosis criteria
* and/or an identified mutation in BBS genes or ALMS1 gene

  * The inclusion of children is essential to a cohort study that is attempting an early identification of visual, metabolic and renal abnormalities. Many of the age-dependent manifestations of BBS develop during childhood and the average age of diagnosis is 9.2 years

Exclusion Criteria:

* Serious active intercurrent pathology that may impact the collected data
* Patient under judicial protection
* Participation in another interventional clinical trial which includes an exclusion period
* Non protected adult with difficulty of comprehension, or inability to understand the delivered information (emergency situation ...).
Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity Assay for Hepatocellular Carcinoma After Liver Transplantation

This study is a randomized, open-label, controlled study that will explore the efficacy of individualized adjuvant chemotherapy based on the adenosine triphosphate tumor chemosensitivity assay for patients with hepatocellular carcinoma after liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had experienced liver transplantation with histologically confirmed advanced hepatocellular carcinoma with more one risk factor (tumour burden \>8 cm, AFP\>400 ng/mL,poorly differentiated,vessels invasion )
* No extrahepatic metastasis confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
* Additional inclusion criteria were age 18 years or older
* Karnofsky performance status (KPS) of at least 70%
* Adequate renal function, defined as creatinine clearance greater than 30 mL/min)
* Adequate hepatic function, defined as ALT and AST less than 5× upper limit of normal
* Adequate bone marrow function, defined as platelets greater than 100×10E9/L and WBC greater than 3.5×10E9/L.

Exclusion Criteria:

* The presence of any severe concomitant disease that could interrupt the planned treatment; intractable pain
* Hypersensitivity to study drugs
* Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 4 weeks of study start)
* National Cancer Institute CommonToxicity Criteria (NCI-CTC) grade 3 or 4 sensory or motor neuropathy
* Prior or concurrent malignancy (other than pancreatic cancer)
* Female, pregnancy or breastfeeding.
A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer

Main research purpose: To evaluate the effectiveness of Fluzoparib combined with apatinib mesylate in the treatment of patients with metastatic castration-resistant prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation and written informed consent;
2. Age ≥18 years old;
3. Pathologically diagnosed metastatic castration-resistant prostate adenocarcinoma;
4. It is confirmed by the central laboratory based on tumor tissue or ctDNA detection that it is accompanied by germline or system homologous recombination repair-related gene mutations (Cohorts 4) or not accompanied by homologous recombination repair-related gene mutations (Cohort 2);
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
6. Has a life expectancy of ≥ 12 weeks.

Exclusion Criteria:

1. Past (within 5 years) or concurrently suffering from other malignant tumors, except for cured skin basal cell carcinoma;
2. Subjects have used PARP inhibitors in the past, including but not limited to olaparib, niraparib, and lukapanib; or have used apatinib in the past; or have received mitoxantrone and cyclophosphamide in the past Treatment with amide or platinum-containing chemotherapeutics;
3. Severe bone injury caused by tumor bone metastasis, pathological fractures or spinal cord compression in important parts that occurred within 6 months before being informed or is expected to occur in the near future;
4. The subject has cancerous meningitis, or untreated central nervous system metastasis;
5. Those who cannot swallow pills normally, or have abnormal gastrointestinal function, which may affect drug absorption by the researcher;
6. Subjects with congenital or acquired immune deficiencies (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥500 IU/ml; hepatitis C reference: HCV antibody positive and HCV virus copy number\> upper limit of normal );
7. According to the judgment of the investigator, the subject has other factors that may cause the study to be terminated halfway, such as other serious diseases (including mental illness) that require combined treatment, severe laboratory abnormalities, family or society, etc. Factors that will affect the safety of subjects or the collection of data and samples.
An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

The purpose of this study is to examine the long-term safety of Abatacept for the treatment of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of serious infections, autoimmune disorders, and malignancies.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Diagnosis of JIA (any subtype)
* Age \< 18 years at the time of enrollment unless currently or previously enrolled in an abatacept clinical trial and received abatacept
* Receiving Abatacept at the time of enrollment as per treating physician's decision or received abatacept in a clinical trial
* Parent or legally acceptable representative willing to participate in the study and sign the informed consent

Exclusion Criteria:

* Pregnant or nursing female at the time of enrollment
* Prior malignancies if the patient has not been malignancy free for at least 5 years.
* Any serious acute or chronic medical condition other than JIA, including chronic infection, which would compromise the patient's ability to participate in the study
* Known poor compliance with clinic visits (based on physician judgment)
Effect of Heredity and Environment on Asthma Development and Severity in Puerto Rican Children

Asthma is a major public health problem among Puerto Ricans. Little is known, however, about the effect of heredity and environment on the development and severity of asthma in this population. This study will examine the relationship between asthma and certain genetic and environmental factors in Puerto Rican children.

Asthma is a chronic disease that causes constriction of the airways. People with asthma may experience wheezing, coughing, chest tightness, and trouble breathing. Although asthma is a major public health problem among Puerto Ricans, little research has been done to determine the influence of heredity and environment on the disease in this population. To learn more about these relationships, this study will examine the effects of certain genes and allergens on the development and severity of asthma in Puerto Rican children.

This observational study will recruit both children with asthma and children without asthma. Participants will meet with study staff twice during the study. The first visit will take place at participants' homes. Participants will complete questionnaires about demographics, respiratory and general health, and household characteristics. Lung function testing, collection of blood samples, and collection of household dust samples will also take place at the home-based visit. The second visit will take place at the study site. At this visit, participants will undergo allergy tests on the skin and a methacholine challenge test to assess their airway responsiveness and asthma severity. The methacholine challenge test will involve inhaling mist through a mouthpiece and blowing forcefully into a special apparatus called a spirometer. Parents will be asked to provide information about their children's exposure to pets in early life. Each visit will last approximately 1.5 hours and will be scheduled close to the date on which a participant enters the study.

Eligibility Criteria:
Inclusion Criteria:

For participants with asthma:

* Diagnosis of asthma
* History of wheezing within 12 months prior to study entry
* Has four grandparents that were born in Puerto Rico

For participants without asthma:

* No diagnosis of asthma
* No history of wheezing within 12 months prior to study entry
* Has four grandparents that were born in Puerto Rico

Exclusion Criteria:

* Significant pulmonary disease other than asthma
* Hospitalization in the neonatal intensive care unit and requiring ventilatory support
* History of cigarette smoking for more than 5 pack-years (\[number of packs smoked per day\] x \[number of years of smoking\])
Feasibility of a Wireless Patch System (WPS) to Measure Gastrointestinal Motility and Gastric Emptying

The purpose of this study is to evaluate the utility of a new device - an external wireless patch system (WPS) - to measure gastric motility and to compare this external wearable device with the most commonly used test to measure stomach emptying, the nuclear medicine gastric emptying scan (also called gastric scintigraphy).


Eligibility Criteria:
Inclusion Criteria:

* Referred to the nuclear medicine department for a scintigraphic gastric emptying scan.

Exclusion Criteria:

* Have had prior gastric or esophageal surgery.
* Have had surgery to the GI tract within the last 60 days (e.g., appendectomy, cholecystectomy).
* Are on chronic opioids or other medications known to affect gastric emptying (e.g., GLP-1 agonists, high dose tricyclic agents).
* Have been recently hospitalized for complications of diabetes or have a HgbA1c \> 10.
* Have severe psychological distress preventing study participation.
* Unable to read or understand the consent form.
PAIN OUT: Improvement in Postoperative PAIN OUTcome

PAIN OUT is a multi-national, non-interventional registry and benchmark project, assessing and analysing clinical and patient-reported outcome data of postoperative pain.

PAIN OUT offers a large registry as well as a system for benchmarking and feedback of outcome quality and decision support in acute pain conditions. It collects demographic, clinical and outcome data, using a validated assessment tool available in multiple languages.

The registry part of the project aims at performing population-based research. Furthermore, its infrastructure allows for the conduct of prospective studies comparing the effectiveness of processes of care.

The benchmark part of the project provides the medical community with a unique, user-friendly system to improve treatment of patients with postoperative pain. A web-based information system, featuring two main functions, was developed:

1. a feedback and benchmarking system which provides participating sites with continuously updating data and analyses about the quality of care they provide compared to other institutions and allows identification of best clinical practice.
2. a knowledge library which provides clinicians with easily accessible and regularly updated summaries of evidence-based recommendations tailored to specific post-operative situations.

PAIN OUT is leading and overseeing sub-projects in Mexico, China, a number of European countries. Additional countries will join over time. The sub-projects are scheduled to take place over a period of two years. The design is an uncontrolled pre- post-study, in which approximately 10 hospitals from each country participate. The project consists of collecting data (processes and patient reported outcomes) at baseline from 1-3 wards in participating hospitals; analyzing of the findings, selecting and implementing measures for change in practice; carrying out another round of data collection; summerizing the findings and discussing options for further work.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years or \>= 4 years for sub-project QUIPSI/PAIN OUTinfant
* patient is post-op day 1
* patient is at least 6 hours on the ward
* patient has given consent

Exclusion Criteria:

* patient cannot communicate
* patient is cognitively impaired
* patient is asleep
* patient is too ill
* patient does not want to fill in the questionnaire
Intravitreal Injection of MSCs in Retinitis Pigmentosa

The purpose of this study is to determine the feasibility and safety of adult human bone marrow-derived mesenchymal stem cells by intravitreal injection in patients with retinitis pigmentosa.

Retinitis pigmentosa (RP) is an inherited disorder of the photoreceptor cells in the retina. Patients may lose vision since they were young or later in life. Currently, there are more than 60 genes identified as the cause of this condition, one of which, RPE65, has been studied in several gene therapy trials for Leber congenital amaurosis with promising results. Another treatment approach for RP is stem cell therapy. Studies in animal models of RP have shown that subretinal injection of bone marrow-derived mesenchymal stem cells may delay degenerative changes of photoreceptor cells.

Eligibility Criteria:
Inclusion Criteria:

* Retinitis pigmentosa patients diagnosed by ophthalmologists
* Age 18-65 years old
* Central visual field less than or equal to 20 degrees
* Best corrected visual acuity less than 6/120 by Snellen visual acuity chart
* Electroretinogram nonrecordable or the amplitudes were less than 25% of normal

Exclusion Criteria:

* Other eye conditions that could mask the interpretation of the results
* Unable to return for follow up
* Underlying diseases including asthma, heart failure, myocardial infarction, liver failure, renal failure
* Pregnant and lactating women
Study of Disrupted Sleep in Somali Americans

The aims of this study are to determine the types and severity of previously undiagnosed sleep deficiencies in otherwise healthy Somali Americans, apply a research framework to define psychosocial, behavioral, environmental, and biological mechanisms mediating sleep deficiencies in Somali Americans, and examine the relationship between sleep deficiencies and increased blood pressure in Somali Americans.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with no known history of hypertension, diabetes, or sleep disorders.
* Self-identify as Somali.
* Adult males and females who are older than 18 years of age.

Exclusion Criteria:

* Anyone under 18 years or over 70 years.
* Positive pregnancy.