cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus (SLE).
* Active disease at screening.
* Stable use of one immunosuppressive drug.
* Use of an antimalarial drug.
* For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation.

Exclusion Criteria:

* Unstable patients with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.
* Active moderate to severe glomerulonephritis.
* Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE.
* Lack of peripheral venous access.
* Pregnant women or nursing (breast feeding) mothers.
* History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies.
* Significant, uncontrolled medical disease in any organ system not related to SLE that in the investigator's opinion would preclude subject participation.
* Concomitant conditions that require oral or systemic corticosteroid use.
* Known human immunodeficiency virus (HIV) infection.
* Known active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics.
* History of deep space infection.
* History of serious recurrent or chronic infection.
* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ.
* Active alcohol or drug abuse, or history of alcohol or drug abuse.
* Major surgery.
* Previous treatment with CAMPATH-1H antibody.
* Previous treatment with any B cell-targeted therapy.
* Treatment with any investigational agent within 28 days of screening (Day -7) or 5 half-lives of the investigational drug (whichever is longer).
* Receipt of a live vaccine within 28 days prior to screening.
* Intolerance or contraindication to oral or IV corticosteroids.
* Use of a new immunosuppressive drug prior to screening or change in dose of ongoing immunosuppressive drug prior to screening.
* Prednisone dose of ≥ 1 mg/kg/day prior to screening.
* Treatment with cyclophosphamide or a calcineurin inhibitor.
* Treatment with a second immunosuppressive or immunomodulatory drug.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 x the upper limit of normal.
Autologous Fat Graft Alleviate Scar Pain

Traumatic wounds inflict small- and large-fiber sensory nerve damage, causing neuropathic pain in scar tissue. Autologous fat grafting has been clinically shown to improve scar quality, but scantly study has explored its effects on pain. The aim of the study was to survey its effect on pain.

Methods: From February 2008 and June 2013, a total of 36 patients received autologous fat grafting in scar areas. Patients who Douleur Neuropathique 4 Questions (scores \>4/10) were enrolled this study. The Visual Analogue Scale (VAS), and Neuropathic Pain Symptom Inventory (NPSI) were used to evaluate pain preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks. The mechanism of trauma, duration of allodynia, fat graft volume, and total follow-up time were recorded.

Eligibility Criteria:
Inclusion Criteria:

* February 2008 and June 2013, patients received autologous fat grafting in scar areas and also had pain over scar area before surgery

Exclusion Criteria:

* patients refused to participate the study
Pharmacokinetic Profile of OROS Hydromorphone in Healthy Taiwanese Participants With Different Genotypes for the UGT2B7 Gene

The purpose of this study is to investigate the pharmacokinetics of OROS hydromorphone in healthy adult Taiwanese participants after the oral administration of a single 16 mg dose.

This is a single-center, open-label (all people know the identity of the intervention), single-dose study in healthy adult Taiwanese participants. A minimum of 6 participants identified as having the UGT2B7 \*2/\*2 variant genotype and 12 participants identified as having the UGT2B7 \*1/\*1 wild type genotype will be included in the study. The study will explore the impact of genetic polymorphism in the UGT2B7 gene (occurrence of variants of this gene) on the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of OROS hydromorphone. This study consists of a screening phase followed by a 5-day open-label treatment phase. During the screening phase, a blood sample will be collected for a genetic test to confirm the presence of the UGT2B7 gene. During the study period, upon completion of a 12-hour overnight fast, participants will receive a single oral 16-mg dose of OROS hydromorphone in the morning of Day 1. Blood samples will be collected through 72 hours after dosing for the determination of plasma hydromorphone and hydromorphone 3-glucuronide concentrations. The safety and tolerability of 16-mg OROS hydromorphone will also be assessed. The total study duration for each participant is approximately 33 days.

Eligibility Criteria:
Inclusion Criteria:

* Participation in the DNA analysis to confirm UGT2B7 genotype status
* Body mass index (BMI) between 18 and 25 kg/m², inclusive and a body weight of not less than 50 kg
* Participants must utilize a medically acceptable method of contraception throughout the entire study period and for 1 month after the study is completed
* Each participant will receive a naloxone challenge test for opioid dependency at screening. Only those participants who pass this challenge test will be allowed to continue in the study

Exclusion Criteria:

* History of or current clinically medical illness or any other condition that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis
* Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG)
* Use of certain prescription or nonprescription medication, and consumption of products that may interfere with the study
Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP): Efficacy and Safety.

TPO-r Switch is a retrospective study of the patients affected by Immune Thrombopenia (ITP) who received alternatively romiplostim and eltrombopag.

Thrombopoietin mimetics agents are available since 5 years in France through clinical trials first and then after their license. Two drugs are used: romiplostim and eltrombopag. These molecules have the same receptor on the megacaryocyte and induce the same stimulation of this cell leading to the differentiation and the proliferation into platelets. But romiplostim and eltrombopag have 2 different characteristics: the way of administration (oral for eltrombopag and subcutaneous for romiplostim) and the binding site to the C-MPL receptor on megacaryocyte. The aim of this study is to describe ITP patients who received these two drugs alternatively in order to know if there is a benefit for switching these molecules in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (Rodeghiero et al, 2009).
* Subject is equal to or greater than 18 years of age.
* Before any study-specific procedure, the appropriate written informed consent must be obtained.
* Subject receiving romiplostim and eltrombopag alternatively
* Available follow-up of 2 months at least for each period

Exclusion Criteria:

- Secondary ITP e.g: thrombopenia related to hepatitis C, HIV, Chronic Lymphocytic Leukemia
Effect of Various Intensities of tDCS on Dual Task Cognitive Functions in Normal Subjects

Transcranial Direct Current Stimulation (tDCS) is a neuroregulatory method that delivers a weak straight tendency to neuronal areas with the intention of changing the brain's basic metabolic processes. Degradation of executive performance may not necessarily arise from cathodal stimulation, and vice versa for anodal stimulation.

Total 48 samples were taken, were randomly allocated into an experimental group of 4 variance of different intensities of tDCS. At F3 and F4, tDCS was applied to the desired region. Electrodes were put in using the 10-20 EEG technique throughout the parietal cortex, with the current electrode being set on F3 area and control electrode being positioned on the F4 area. For 20 minutes over three days per week for up to three weeks, current intensities of 0.5mA for group A, 1.0mA for group B, 1.5mA for group C, and 2.0mA for group D were administered. when engaging in dual-task cognitive processes. The groups are going to receive 9 sessions of tDCS treatment. The MoCA and TMT scale was completed by samples before and after the intervention. Finally, specifics investigation will be carried out using SPSS 26.0 software.

Eligibility Criteria:
Inclusion Criteria:

* Physically healthy students only
* Willing to participate in the study

Exclusion Criteria:

* Any recent trauma or injury on the head of subjects
* If contact with the scalp is not possible
* Any resonant implant close to electrode placement site
Medical Recovery and Social Reintegration for Post-stroke Patients Using Virtual Reality

Application of Virtual Reality therapy and occupational therapy versus and standard physiotherapy and occupational therapy to patients with post-stroke sequelae, using specifical assessment tools, standard physiotherapy and occupational therapy programs.

1. Initial and final clinical and functional evaluation of patients with post-stroke sequelae, storage and use of data obtained.
2. Collection and access of demographic and clinical data of patients included in the study (respecting the principle of confidentiality and non-publication of personal data) only by staff involved in the research project and working in the Clinical Hospital of Psychiatry and Neurology in Brasov.
3. Application of Virtual Reality therapy and occupational therapy versus and standard physiotherapy and occupational therapy to patients who meet the criteria for inclusion in the study (scapulohumeral flexion and abduction of at least 20 degrees, elbow flexion of at least 20 degrees, hip and knee flexion of at least 20 degrees, without severe aphasia or severe behavioural/cognitive disorders).
4. Use of data obtained from the application of Virtual Reality therapy at home, through Telerehabilitation, if patients procure alone or through sponsorship/donation the equipment necessary to continue the Virtual Reality therapy program at home, taking into account that the technology purchased through the project allows this.

Eligibility Criteria:
Inclusion Criteria:

1. stroke survivors after the acute phase, at least 6 weeks post-stroke;
2. stroke survivors within no more than 4 years after stroke,
3. at least 30-degree flexion and scapulohumeral abduction against gravity.
4. elbow flexion of at least 30 degrees
5. hip flexion of at least 30 degrees
6. knee flexion of at least 30 degrees

Exclusion Criteria:

1. no severe cognitive impairments,
2. no global or transcortical sensory aphasia,
3. no other dysfunctions in the upper extremity such as surgery, fractures, shoulder arthritis or severe pain,
4. no other dysfunctions in the lower extremity such as surgery, fractures, arthritis or severe pain,
5. without anaemia
6. without atrial fibrillation
7. without NYHA class IV heart failure
A Safety and Efficacy Study of MIM-D3 Ophthalmic Solution for the Treatment of Dry Eye

The purpose of this study is to assess the safety and efficacy of MIM-D3 Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Provided written informed consent
* Have a reported history of dry eye
* Have a history of use or desire to use eye drops for dry eye

Exclusion Criteria:

* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1, or have been diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months
* Have any planned ocular and/or lid surgeries over the study period
* Have corrected visual acuity greater than or equal to +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1
* Have an uncontrolled systemic disease
* Be a woman who is pregnant, nursing or planning a pregnancy
* Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study
* Have a known allergy and/or sensitivity to the test article or its components
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days of Visit 1
* Be unable or unwilling to follow instructions, including participation in all study assessments and visits
Studying Tumor Tissue Samples From Patients Who Have Undergone Surgery for Localized Kidney Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor tissue samples from patients who have undergone surgery for localized kidney cancer.

OBJECTIVES:

* To identify consistent patterns of VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity as predictive factors in the development of aggressive tumor behavior in tumor tissue samples from patients with localized clear cell renal cell carcinoma.

OUTLINE: Previously collected tumor tissue samples are examined by immunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity). Samples are compared to positive tissue controls (i.e., VEGF- tonsil; E- cadherin-normal breast or endometrium; MMP2- placenta) and a negative control (i.e., isotype matched normal serum) to identify consistent patterns of expression/activity of these factors. Levels of expression are quantified as 5-level scores (0 to 4 scale) and differences between any two areas of a tumor are analyzed.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Tumor tissue samples from patients who recently underwent nephrectomy or partial nephrectomy for clear cell renal cell carcinoma

  * Harvested from the superior, inferior, left lateral, right lateral, and central portions of resected or discarded tumor measuring 4 cm or less
  * Localized disease (pT1a, N0-Nx, M0)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome

This study aims to investigate the prevalence of subclinical oculomotor disorders in a population of patients with radiologically isolated syndrome.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his informed consent and signed the consent form.
* The patient must be affiliated or beneficiary of a health insurance plan.
* The patient is at least 18 years old (≥) and under 50 years old (≤).
* Patients with radiologically isolated syndrome according to the criteria of Okuda et al. (2009)
* Diagnosis of a radiologically isolated syndrome confirmed by the national expert center of Nice for less than 3 years.

Exclusion Criteria:

* The subject participates in another study.
* The subject is in an exclusion period determined by a previous study.
* The subject is under guardianship, curatorship or safeguard of justice.
* The patient is pregnant or breastfeeding
* The subject refuses to sign the consent.
* It is not possible to give the subject informed information.
* Patient presenting a pathological neurological examination.
* Patient with visual acuity less than 5/10 or with ocular instability
Follow-up of NIV At Home in Patients with Duchenne Muscular Dystrophy

The aim of this study is to verify whether full video home polysomnography (sleep study) with nocturnal transcutaneous CO2 monitoring is feasible in the follow-up of non-invasive ventilation (NIV) in patients with Duchenne muscular dystrophy. The researchers would like to investigate whether they could perform sufficient measurements in the home situation and see if correct decision for further treatment could be made. Furthermore, the researchers will make an analysis on the minimal requirements of measurements to make a correct decision for the treatment of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with DMD \> 18 years using NIV
* Signing the written informed consent

Exclusion Criteria:

* /
A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone

This is a phase Ⅲ, multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of narlumosbart (JMT103) in patients with unresectable or surgically difficult giant cell tumor of bone (GCTB). This clinical trial study hypothesizes narlumosbart administration groups are not inferior to active control administration groups.


Eligibility Criteria:
Inclusion Criteria:

1. Fully informed and signed informed consent;
2. Male or female adults aged ≥ 18 years or skeletally mature adolescents must weigh at least 45 kg and ≥ 12 years of age;
3. Pathologically confirmed giant cell tumor of bone that is surgically unresectable or for which the planned surgery is associated with functional compromise or morbidity;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Exclusion Criteria:

1. Previous or ongoing osteomyelitis or osteonecrosis of the jaw, non-healed dental/oral surgery, active dental or jaw condition requiring oral surgery, planned invasive dental procedure during the study;
2. Known or suspected diagnosis of other giant cell-rich tumors, brown cell tumor of bone, or Paget's disease;
3. Known diagnosis of malignancy within the past 5 years, except for definitively treated superficial basal cell carcinoma or cervical carcinoma in situ;
4. Bone metabolic disease including hypo-/hyperparathyroidism, hypo-/hyperthyroidism (except for no need treatment subclinical hypothyroidism), hypopituitarism, hyperprolactinemia, Cushing's syndrome, acromegaly, etc.;
5. Active infections requiring systematic treatment within 7 days prior to randomization;
6. Known human immunodeficiency virus (HIV), syphilis infections or viral hepatitis;
7. Current receiving other anti-tumor therapy (such as radiation, chemotherapy, or embolization, etc.);
8. Concurrent bisphosphonate treatment;
9. Use of anti-receptor activator of nuclear factor-κB ligand (RANKL) antibody within six months prior to screening, or no response to previous RANKL antibody treatment;
10. Known allergic/hypersensitive reaction to JMT103, positive control drug, calcium and vitamin D;
11. Pregnant or lactating females; For those of child bearing potential, refusal to use effective contraception methods from signing informed consent to 6 months after last administration.
Williams Syndrome Strength, Hormones, Activity & Adiposity, DNA Programming, Eating Study

Williams syndrome (WS) is a rare microdeletion genetic disorder that has a broad phenotype including many endocrine and metabolic abnormalities. Dr. Pober and colleagues at MGH have reported the following findings in adults with WS: abnormal body composition (excess body fat accumulation with a lipedema phenotype), decreased bone mineral density, abnormal glucose tolerance, and reduced lean mass. Despite the high prevalence and potential effect of metabolic abnormalities on the health of persons with WS, their full phenotypic range, potential causal factors (either genetic and/or hormonal) along with their impact on other aspects of health (such as risk of falls and fractures or interaction with emotional behavioral concerns) remain incompletely characterized. The purpose of the current study in a large cohort of subjects with WS is to: collect further information to characterize the timing of onset and distribution of body fat; better characterize hormonal status of WS subjects; and screen for genetic variation using single-nucleotide-polymorphism (SNP) analysis that could elucidate genetic contributors to the lipedema phenotype as well as the other observed metabolic and bone abnormalities.


Eligibility Criteria:
For those participating in-person at Massachusetts General Hospital:

Inclusion Criteria

1. Male or Female age 18-70 years old
2. Diagnosis of Williams syndrome (WS), established by experienced clinician, parent report, or confirmed by genetic testing such as FISH (fluorescent in situ hybridization) or chromosomal microarray (WS only)
3. Availability of a parent or guardian to review details of the study with their family member with WS and participate in the consent process (all WS regardless of age)
4. Availability of a parent or guardian to provide selected medical information (WS only)

Exclusion Criteria

1. History of weight loss surgery or liposuction
2. Positive urine pregnancy test (females only)
3. Obesity or abnormal fat distribution due to a known secondary cause (except WS) such as Cushing syndrome, HIV-infection, etc.