cyrilzakka/clinical-trials huggingface dataset:
A Real World Study About PMN

We designed a randomized, controlled, multicenter clinical study to compare the efficacy and safety of rituximab combined with hormones versus rituximab monotherapy in the treatment of primary membranous nephropathy. At the same time, we conducted a real-world study on patients who did not meet the inclusion and exclusion criteria or were unwilling to enter the RCT cohort, to further observe the trial results in a broader population.

Outcomes

* Primary objective Treatment of primary membranous nephropathy with conventional clinical protocols and observation of its effectiveness and safety in a wide population.
* Exploratory purpose

  1. Evaluate the genome-wide changes in kidney and peripheral blood during treatment.
  2. To evaluate the changes in the single-cell transcriptome of the kidney and peripheral blood during treatment.
  3. Evaluate the changes in the RNA transcriptome of the kidney and peripheral blood during treatment.
  4. Evaluate the changes in the renal and peripheral blood proteome during treatment.
  5. Assess the changes in the metabolome during treatment.
  6. Assess changes in the microbiome during treatment.
  7. Predict the effective population of rituximab by baseline renal pathological images.
* Primary outcome The complete response rate at 12 months;
* Secondary outcomes

  1. Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response);
  2. Median remission time;
  3. Proportion of patients without recurrence at 12, 18 and 24 months;
  4. Median non-recurrence time;
  5. Cumulative dose of glucocorticoids;
  6. CD19+ cell count, anti-PLA2R antibody expression level;
  7. Renal function index: eGFR;
  8. Incidence of adverse events;

Eligibility Criteria:
Inclusion Criteria:

1.Men and Women aged over 18 years; 2.Patients diagnosed as primary membranous nephropathy (PMN) by renal biopsy; 3.After treatment with ACE inhibitors or ARBs for at least 3 months, those who have an average 24-hour urine protein ≥ 3.5g twice a week.

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Exclusion Criteria:

1. Patients with secondary membranous nephropathy (such as hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes;
2. Active infection, such as active hepatitis B or hepatitis C, tuberculosis (evidence of active tuberculosis infection within 1 year), or human immunodeficiency virus HIV infection (positive for anti-HIV antibodies), etc.
3. A history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or organ transplantation.

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A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723

Study IDS116406 will be a non-interventional, phlebotomy study in Hunter Syndrome patients who are currently being treated with idursulfase, an enzyme replacement therapy, and in at least a single patient who is naïve to treatment, if possible to recruit. All patients enrolled into the study will have a single blood draw for the analysis of antibodies induced by this enzyme replacement therapy (idursulfase). Patient samples with positive responses to antibodies induced by idursulfase will be used to further evaluate whether the antibodies induced by idursulfase bind to GSK2788723 molecules in vitro and if these antibodies neutralize the bioactivity of GSK2788723 in vitro. Each subject will have a screening visit, which may occur at their regularly scheduled out-patient visit. If the patient consents to participate in the study, a blood sample (total volume of approximately 3mL) for immunogenicity analysis will be drawn before their current treatment infusion

Study IDS116406 will be a non-interventional, phlebotomy study in Hunter Syndrome patients who are currently being treated with idursulfase, an enzyme replacement therapy, and in at least a single patient who is naïve to treatment, if possible to recruit. All patients enrolled into the study will have a single blood draw for the analysis of antibodies induced by this enzyme replacement therapy (idursulfase). Patient samples with positive responses to antibodies induced by idursulfase will be used to further evaluate whether the antibodies induced by idursulfase bind to GSK2788723 molecules in vitro and if these antibodies neutralize the bioactivity of GSK2788723 in vitro. Each subject will have a screening visit, which may occur at their regularly scheduled out-patient visit. If the patient consents to participate in the study, a blood sample (total volume of approximately 3mL) for immunogenicity analysis will be drawn before their current treatment infusion

Eligibility Criteria:
Inclusion Criteria:

A subject will be eligible for inclusion in this study only if patient meets criteria 1 and 2 or 1 and 3:

* Diagnosed with Hunter syndrome
* Patients with Hunter syndrome who are being treated with idursulfase
* Patients with Hunter syndrome who are naïve of idursulfase treatment (if possible\*) \*This study will also attempt to recruit 1 patient who has never received idursulfase. If a naïve patient has not been identified within an agreed amount of time between GSK and the investigator, the study will concluded without this sample

Exclusion Criteria:

* Subjects who are currently participating in another clinical trial are not permitted to be enrolled in this study.
The Impact of Carbon Monoxide and Altitude on Vascular Function

The CarMA (Carbon Monoxide and Altitude) Study aims to observe the vascular effects of carbon monoxide exposure at low and high altitudes.

Each year, millions of people make journeys from low altitude regions to high altitude for recreation, travel, and religious pilgrimage. Carbon monoxide (CO) is commonly associated with cigarette smoke, exhaust fumes, and is viewed as a life-threatening toxic gas. Exposure to CO occurs during travel to and during activities common in high-altitude travel and pilgrimage including vehicle fumes, incense, and second-hand smoke exposure. High altitude exposure and CO exposure have been observed independently to have complex and opposing effects on vascular endothelial function. Observation of these stimuli together in a controlled environment may allow for further understanding of the underlying mechanisms of vascular physiology and adaptations to both high-altitude and CO exposure. The CarMA (Carbon Monoxide and Altitude) Study aims to observe the vascular effects of carbon monoxide exposure at low and high altitudes. Recently, other studies have showed a significant improvement in flow mediated dilation (FMD) with acute exposure to low levels of CO To date, no research has been presented concerning the effect of CO on vascular function at altitude. The present study aims to observe the effect of acute carbon monoxide exposure on 1) flow mediated dilation, 2) conduit artery flow in exercise induced reactive hyperemia at sea level and at altitude, and 3) the effect of CO on vascular function in a high altitude dwelling (sherpa) population.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-50 years
* No medical history of cardiovascular, respiratory, nervous system, or metabolic disease.
* Women must be pre-menopausal.

Exclusion Criteria:

* Participants with any known cardiovascular, respiratory, nervous system, or metabolic disease.
* Having travelled above 2,000m within 1 month of testing at low and high altitude.
* Women who are pregnant, confirmed by a pregnancy test.
* Women who are post-menopausal.
* Participants that are classified as obese (body mass index \> 30 kg/m2).
* Participants who are current daily smokers.
* Participants that are currently taking monoamine (MAO) inhibitors, or tricyclic antidepressants.
A Study Treating Participants With Early Axial Spondyloarthritis (axSpA) Taking an Intense Treatment Approach Versus Routine Treatment

A study comparing a treat-to-target (T2T) intense treatment approach with routine treatment (Standard of Care \[SOC\]) in reducing disease activity in participants with axial spondyloarthritis (axSpA).


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent before start of study-related assessments or procedures
* Diagnosis of axSpA (either ankylosing spondylitis or non-radiographic axSpA) and fulfilling the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axSpA
* Participants aged ≥ 18 years
* Disease duration \< 5 years
* Participants must have a Baseline disease activity as defined by an ASDAS ≥ 2.1 or a Bath AS Disease Activity Index (BASDAI) ≥ 4
* NSAID-naive or not treated with the maximal recommended NSAID dose during the last 2 weeks prior to the Baseline visit
* Participants must never have failed a NSAID taken at maximal recommended dose for 2 weeks or more.

Exclusion Criteria:

* Contraindications for NSAIDs or tumor necrosis factor (TNF) blocker according to local labeling
* If entering the study on concomitant NSAIDs, participants taking the maximal recommended dose during the last 2 weeks prior to the Baseline Visit or have failed or developed intolerance to a NSAID taken at maximal recommended dose for 2 weeks or more at any time
* Prior exposure to any anti-TNF therapy; any biologic therapy with a potential therapeutic impact on SpA, or participant has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Baseline visit.
Comparison of Therapeutic Effects of Trigger Point Injection and Twin Nerve Block in Chronic Myofascial Pain Patients

To see if there is there any difference in the treatment outcomes/results such as changes in pain intensity in patients with myofascial pain who have been treated with trigger point injections or twin block?

Most treatment approaches for chronic myofascial pain are not evidence-based. Studies are usually controversial. Most are short-term, non-randomized. An essential limitation has been the lack of standardization of diagnosis. Some studies do not differentiate between joint pain and muscle pain, which can significantly affect the outcome of the treatment provided.

Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) was recently published and validated. Their protocol allows standardization of the assessment and diagnosis of patients with temporomandibular disorder, including myofascial pain.

To the investigator's knowledge, no previous prospective, randomized study has been conducted demonstrating the treatment outcomes of either trigger point injections or twin block in patients with chronic myofascial pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Myofascial pain with referral based on the DC/TMD criteria
* Pain on the masseter and or temporalis muscles
* Pain present for at least 3 months

Exclusion Criteria:

* Generalized muscle disorder such as fibromyalgia
* Subjects on chronic pain medication
* Subjects who are known to have hypersensitivity to the local anesthetics.
* Pregnant women. A pregnancy test will not be given before subject enrollment. Women of childbearing ages will be asked verbally if they are pregnant. If they are unsure, then they will be excluded from the study.
* Subjects with cognitive problems e.g. Alzheimer's disease.
Developing Mouse Models of Breast Cancer Using Tissue Samples From Women With Breast Cancer

RATIONALE: Changing the genes in laboratory mice to create a living model of human breast cancer may help doctors learn more about breast cancer.

PURPOSE: This research study is developing mouse models of breast cancer using tissue samples that were previously collected from women with breast cancer.

OBJECTIVES:

* To develop new in vivo models of human breast cancer.
* To correlate response in this model to actual treatment outcome in patients, if the in vivo model is proven feasible.

OUTLINE: Previously collected breast tumor fragments are implanted into the renal capsule site of SCID mouse hosts (mouse with severe combined immune deficiency) to establish metastatic spread patterns, and both histologic and molecular tumor characteristics.

Patients' medical charts are reviewed to obtain relevant information, including general demographics, smoking and alcohol use, as well as outcome data such as survival and response to treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

  * Any stage of disease
  * Primary or metastatic disease
* Human breast tumor tissues available after the diagnoses have been made
* Enrolled on the ongoing Breast Tissue Repository trial VU-VICC-BRE-03103

  * Have consented to the use of their tissues for research purpose
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Core Strengthening vs Pilates Exercises on Posture, Body Awareness and Fatigue Among Female Athletes

The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive Core Strengthening exercises. Group B will receive Pilates exercises.

The objective of the study is to determine the Effects of Core Strengthening and Pilates Exercises on Posture, Body Awareness, and Fatigue among Female Athletes. The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive Core Strengthening exercises. Group B will receive Pilates exercises. York posture rating chart, body awareness scale, and modified fatigue impact scale will be done at the baseline and after the completion of treatment at 6 weeks.

The data will be analyzed by SPSS, version 25. Statistical significance is P=0.05.

Eligibility Criteria:
Inclusion Criteria:

* Amateur female athletes 18-26 years of age,
* Duration of playing at least 6 months to 1 year,
* BMI \<29 kg/m2, Core training not less than 4 weeks,
* Females having no previous injury that could interfere with the study,
* Females are not currently using nutritional supplements

Exclusion Criteria:

* Smoking,
* sleeping medications,
* complementary medicine use over the last six months,
* Stressful events in the past three months,
* presence of a physical or mental illness, or surgical history,
* Presence of any neurological and vascular disease,
* Participants having another exercise program which can affect the results,
* Participants who are not able to participate in any regular exercise program.
Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis

The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA injection.


Eligibility Criteria:
Inclusion Criteria:

* Have radiographic evidence within the prior 6 months, as shown in the radiology reports, of OA grade 2 or 3 using Kellgren-Lawrence Grading for OA.
* Symptoms in the index knee for at least 12 months.
* Fully ambulatory Subject (ability to perform a 15 meters walk test).
* Male and female Subjects 40 through 85 years of age.

Exclusion Criteria:

* BMI \>40 kg
* Secondary OA (acute knee injury, rheumatoid arthritis, gout, history of joint infection, osteonecrosis, chronic fibromyalgia) or other chronic autoimmune disease.
* Intra articular steroid therapy in last 3 months
* Intra articular viscosupplementation in last 6 months
An Intervention to Improve HIV Pre-exposure Prophylaxis Initiation, Adherence and Linkage to Care for Recently Incarcerated Men Who Inject Drugs.

Pre-exposure prophylaxis (PrEP) is effective in preventing HIV infection among people who inject drugs (PWID) yet studies suggest that its use is low among this population which is particularly vulnerable to HIV infection. The criminal justice (CJ) system, at the intersection of increased risk of HIV infection and substance use, presents a unique opportunity to engage PWID in HIV prevention care that incudes PrEP. The study will characterize the facilitators and barriers to PrEP initiation, adherence and linkage to care among male PWID that are experiencing incarceration and develop the "PrEPare-for-Release" intervention to promote PrEP initiation, adherence and linkage to care upon release from incarceration into the community.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Incarcerated at the Rhode Island Department of Corrections
* Identifies as male
* Reports a history of injection drug use
* Meets CDC clinical criteria for PrEP use
* Able to provide written and verbal consent in either English or Spanish

Exclusion Criteria:

* Unable to provide written and/or verbal consent
Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery

Laparoscopic surgery has become very popular and standard in many indications after advancements of technique. Various methods have been used in first entry to the abdomen. Safety, wound size, to be not time-consuming, low cost, learning curve and efficacy are important. Several techniques, instruments, and approaches to minimize the risk of injury (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have been introduced.

There is no consensus yet on an optimal method has yet emerged.

The investigators aimed to evaluate efficacy of entry methods that ensures safe insertion of the first trocar at any site of the abdomen.

To evaluate the efficacy of entry technique, the investigators used cohort of patients who will be planned to laparoscopic obesity surgery.

Two methods are commonly used in surgical literature and in our center.

The investigators have been used visible optical-entry technique in some patients for first entry and Veress technique in some other patients.

For this purpose, the investigators designed an observational study.

Several techniques, instruments, and approaches to minimize the risk of injury (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have been introduced.

These methods include the standard technique of insufflation after insertion of the Veress needle, the open (Hasson technique), the direct trocar insertion and optical trocar insertion. Furthermore, it is more difficult to perform in the obese patient, especially if the first trocar is not umbilical, like obesity surgery. This is because obese patients have a very thick abdominal wall (particularly in women) as well as a thick peritoneum.

Very different complications, some even potentially fatal, i.e., injury to viscera or to major intra-abdominal and abdominal wall vessels, have been reported in surgical literature. Complications of first entry develop in up to 1-2% of patients and more than half of all are fatal complications. Major vascular and abdominal organ injury rates of 0.03-0.1% and 0.08-0.14%, respectively, have been reported. Surprisingly, there has been little change in entry techniques since the dawn of laparoscopic surgery. Some risk factors are defined for prediction of complications, such as obesity. Laparoscopic obesity surgery has become very attractive and gaining popularity, recently, and however it possess many complications and challenges such as (it starts with) entry to the abdomen.

Eligibility Criteria:
Inclusion Criteria:

* Patients with body mass index of \>40

Exclusion Criteria:

* Patients who have skin disease at operation area
Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis

This study will compare the plasma pharmacokinetic profile and the change in disease activity score in patients with active rheumatoid arthritis following treatment with two 1000 mg doses of DRL_RI or one of two sources of rituximab (Rituxan® or MabThera®). Patients will also be monitored for safety, B cell depletion and recovery, and for the development of immune responses to the administered study drugs


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, 18 to 65 years of age
2. Diagnosis of RA, according to ACR criteria (1987), of at least 6 months duration
3. At randomization, tender joint count ≥ 6 and swollen joint count ≥ 6
4. Evidence of at least moderate disease activity
5. Patients receiving oral or parenteral MTX with a dose of 15 to 25 mg per week when given alone or 10 to 25 mg per week in combination with additional non-biologic DMARD(s) for at least 6 months and on stable dose for at least 3 months
6. Patients must be on a stable dose of folic acid or equivalent (≥5 mg per week)
7. Chest X-ray not suggestive of any lung infections including pulmonary tuberculosis (TB)
8. Contraception required per protocol

Exclusion Criteria:

1. Prior therapy with

   * Rituximab, abatacept, tocilizumab, anakinra or an agent/antibody targeting CD20, CD19 or B cells
   * Tumor necrosis factor (TNF) alfa antagonists or other biologic DMARDs

   Other prior or concurrent therapies may also be excluded
2. Any clinically relevant abnormality detected on screening history, physical examination, clinical laboratory, chest X-ray, or electrocardiogram (ECG), other than values consistent with RA
3. Evidence of active, suspected or inadequately treated TB
4. Positive serological test for hepatitis C virus antibodies, hepatitis B surface antigen, hepatitis B core antibody, or human immunodeficiency virus
5. History of cardiovascular disease, history of stroke, or uncontrolled hypertension
6. History of lymphoproliferative disease or organ allograft
7. History of cancer (except for in situ cancer, excised, or limited stage, curatively treated cancer with no sign of disease for \>5 years)
8. History of allergy (medication history) to any of the compounds used in the study
9. Pregnant or lactating women or women planning to become pregnant during the study
Cardiac Surgery and Diaphragm Function

Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical ventilation and cause respiratory distress.

The investigators' main objective is to determine the incidence of diaphragm dysfunction ( using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic thickening fraction) in a selected population of cardiac surgery patients during weaning from mechanical ventilation.

The second endpoints are to determine the associated risk factors to post-operative diaphragm weakness and the consequence on the patient outcome.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and older
* planned surgery
* ready for weaning from mechanical ventilation

Exclusion Criteria:

* protected patient
* patient refusal