cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the RNA Signature of Rheumatoid Arthritis From Synovium and Whole Blood

Rheumatoid arthritis is a systemic disease, it is not clear whether the gene expression profile exhibited by circulated peripheral blood cells and that expressed by the inflamed synovium mirror one another. Understanding this relationship would be useful not only in potentially having a relatively non-invasive means to predict response to therapy but it might be useful in better understanding differences in RA expression amongst patients with this disease, thus perhaps assisting in target identification through a better understanding of disease processes.

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease affecting approximately 1% of the adult population. The disease is characterised by inflammation of synovial tissue (ST) in multiple joints, which often leads to destruction of joint integrity, contributing to serious functional impairment and disability. The contributors to its pathology include joint inflammation, abnormal cellular and humoral responses, and synovial hyperplasia. Ultrasonography is a powerful, non-invasive, and feasible way to evaluate synovial hyperplasia and guide its collection by biopsy.

Eligibility Criteria:
Inclusion criteria

* Adult men and non-pregnant, non-lactating women between 18 and 75 years of age. Sexually active females must be of either non-childbearing potential or willing to comply with the contraceptive requirements
* Body weight greater \>40 kg and \<120 kg with a body mass index (BMI) between 19-31 kg/m2
* Clinical history of rheumatoid arthritis as defined by ACR criteria
* Negative urine pregnancy test for women of child bearing age (except those with documented proof of hysterectomy or bilateral oophorectomy)

For populations B and C only

* Currently on a stable dosing regimen of methotrexate 7.5 to 25 mg once weekly, as their only DMARD (no changes in dosing regimen for 4 weeks prior to screening).

Exclusion criteria

* History of an acute illness within 2 weeks prior to the study
* History of drug abuse within 2 years
* Donation of blood in excess of 500 mL within 56 days prior to the first dose of study medication

For group A only

* Prior treatment with disease modifying anti-rheumatic agents or biologicals.
Interest of the Addition of Docetaxel to Standard Treatment in First-line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients

The purpose of this retrospective study is to evaluate the efficacy and the safety of trastuzumab + chemotherapies with or without taxanes among HER2-positive advanced gastroesophageal adenocarcinoma patients.

Studies have reported a beneficial role of trastuzumab combined to platin-5-FU based chemotherapy in first-line advanced HER2 positive gastroesophageal adenocarcinoma. However, the effect of taxanes combined with platin-5FU + trastuzumab (TPFT) is understudied.

In this context, the aim of this study is to evaluate the efficacy and the safety of trastuzumab + chemotherapies with or without taxanes among HER2-positive advanced gastroesophageal adenocarcinoma patients.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed non-resectable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastro-esophageal junction;
* tumor samples scored as 3+ on immunohistochemistry or FISH (Fluorescence in situ Hybridization) positive (HER2:CEP17 ratio ≥2);
* measurable disease;
* treated by trastuzumab, platin (cisplatine or oxaliplatine), fluoropyrimidine (5-FU or capecitabine) +/- taxanes (docetaxel or paclitaxel),
* as first-line therapy for advanced gastric cancer.

Exclusion Criteria:

* previous chemotherapy by taxane for metastatic disease,
* previous anti-HER2 therapy.
Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa

The objective of our study is to determine the clinical utility related to the maintenance oral nifedipine therapy in patients with symptomatic placenta previa. This study is a prospective, randomized controlled trial with the inclusion, after 24 weeks gestation, of hospitalized patients with symptomatic placenta praevia. All patients may initially receive oral nifedipine therapy with steroid prophylaxis for 48 hours. After then, patients are randomly assigned to receive either oral nifedipine (20 mg every 8 hours) or placebo (one every 8 hours) until 37 weeks of gestation.

The primary outcome for the trial is the length of pregnancy in days after the enrollment. A sample size calculation is designed to detect at least a 14 -day difference in time gained in patients with maintenance oral nifedipine therapy. A sample size of about 52 patients per group would have a 80 % chance of detecting this difference at the 5 % level of significance.


Eligibility Criteria:
Inclusion Criteria:

* Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasonography
* Placenta previa may be symptomatic with at least one episode of bleeding
* Estimated gestational age within 24 to 34 weeks
* Maternal age \> 18 years
* Informed consent after received an explanation of the study and an information sheet
* Social affiliation

Exclusion Criteria:

* Premature rupture of membranes
* Severe bleeding requiring an immediate termination of pregnancy
* Abnormal fetal heart rates requiring an immediate termination of pregnancy
* Intrauterine fetal death
* Pre-eclampsia, chorioamnionitis, liver disease, severe chronic renal disease, heart disease
* Abruptio placentae
* Nifedipine sensibility
* Drugs interaction with nifedipine
Inner and Middle Ear Effects of Hyperbaric Oxygen Thrapy

Audiological evaluation performed to patients on hyperbaric oxygen therapy to see its effects on middle ear pressure

Thirty patients will be recruited from center pf hyperbaric oxygen therapy Every patient who received HBOT was submitted for Demographic data:age,gender,condition raquiring HBOT,use of analgesics,history of diabets ,cardiovascular or respiratory disease ,psychatric illness,smoking history facial/ENT problems and previous HBOT problems then tympanometry and basic pure tone audiometry including air and bone conduction is done following each of the first five treatment

Eligibility Criteria:
Inclusion Criteria:

* patients above 18 years old already recieving hyperbaric oxygen therapy for treatment of other medical conditions required treatment by it as in diabetic foot

Exclusion Criteria:

* patients who already had tympanostomy tubes
Effects of Core Stabilization Exercises vs. Schroth's Program on Posture and Quality of Life in Females With Scoliosis.

The objective of this study is to compare the effects of core stabilization exercises versus schroth's program on posture and quality of life in females with idiopathic scoliosis

Scoliosis is a 3 dimension condition that effects most of our population specifically females. It is not only a bend in your spine but according to new research, its also twisting it. The curvature effects the effected individual physical and the social anxiety due to appearance and a continues state of lethargy effects their quality of life immensely. The posture is poorly effected along with a visual appearance. Often someone with scoliosis might find good posture difficult. Often someone with scoliosis will lean forwards and to the side either slightly or a lot. They will often try to avoid doing this, which can lead to slightly bent knees and the pelvis tilting backwards. Scoliosis is often defined as spinal curvature in the "coronal" (frontal) plane. While the degree of curvature is measured on the coronal plane, scoliosis is actually a more complex, three-dimensional problem which involves all 3 planes. It is defined by the Cobb's angle of spine curvature in the coronal plane and is often accompanied by vertebral rotation in the transverse plane and hypokyphosis in the sagittal plane. These abnormalities in the spine, costal-vertebral joints, and the rib cage produce a 'convex' and 'concave' hemithorax.

Only females having idiopathic scoliosis with cob's angle 10°-26° with age ranging between 19-30 are included and any subjects with surgical interventions are excluded.

Population will be divided in to two groups. One group will perform scroth exercises for 4 weeks and the other group will perform core straightening exercises for 4 weeks each. Once the time period is complete, the posture will be measured using pelvic and shoulder goniometers to check the level of tilt and for quality of lifestyle, we will be using quality of life (Scoliosis Research Society-22 questionnaire)

Eligibility Criteria:
Inclusion Criteria:

* Females only
* Positive Forward bend test (FBT)
* Idiopathic scoliosis
* Cob's angle 10°-26°
* Age group ranged between 19-30 yrs.
* Normal BMI (18.5-24.9 kg/m2)
* Chronic Scoliosis patients
* Riser Sign 4-5

Exclusion Criteria:

* Subjects with any surgical intervention for scoliosis
* Pregnant women
* Subjects with any serious health condition
Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion

A total of 600 patients undergoing coronary procedures via transradial access using 6F sheath were randomized at the end of the procedure to receive either 250-µg nicardipine or 500-µg nitroglycerin administered to the radial artery through the radial sheath before sheath removal. A continuous patent hemostasis was applied in each patient with the use of an oximetry to maintain an oxygen saturation of \>95%, measured in the finger of the accessed arm until compression device was totally removed. The primary outcome is early RAO which was evaluated by color duplex ultrasonography of the accessed arteries at the day after the radial procedure. Secondary outcome was the change of blood pressure at 2-3 minutes after drug administration. Radial artery angiogram was performed after radial sheath insertion and doppler ultrasound of the accesed radial artery was examined at the day after the procedure.

Doppler ultrasound of the accessed artery was performed at the day after the radial procedure in all patients. The absence or presence of antegrade flow in the radial artery will be examined while compressing the ulnar artery as previously described.

The internal lumen radial artery diameter was evaluated by doppler ultrasound as the distance between the inner walls of the artery by personnel that are blinded to the study protocol.

Radial artery angiogram was performed soon after radial sheath insertion and the radial artery diameter was measured in AP projection in all patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing transradial catheterization

Exclusion Criteria:

* Systolic blood pressure \< 100 mmHg
A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer

This is a multicenter, open-label, single-arm, expanded access study designed to provide T-DM1 to patients with HER2-positive locally advanced or metastatic breast cancer and to evaluate the safety and efficacy of T-DM1 administered by intravenous (IV) infusion.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented breast cancer
* Locally advanced or metastatic breast cancer
* HER2-positive breast cancer documented as FISH-positive, IHC 3 + or CISH-positive by local laboratory assessment
* Histologically or cytologically confirmed invasive breast cancer: incurable, unresectable, locally advanced breast cancer previously treated with multimodality therapy or metastatic breast cancer
* Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both: a taxane, alone or in combination with another agent, and Trastuzumab, alone or in combination with another agent in the adjuvant, unresectable, locally advanced, or metastatic setting
* Documented progression of incurable unresectable, locally advanced, or metastatic breast cancer during their most recent treatment regimen
* Progression must occur during or after most recent treatment for locally advanced/metastatic breast cancer or within 6 months after completing adjuvant therapy
* Adequate hematologic and end organ function
* Agreement to use an effective form of birth control throughout the study
* Life expectancy ≥ 90 days as assessed by the investigator

Exclusion Criteria:

* Less than 14 days from the first study treatment since the last anti-cancer therapy, including chemotherapy, biologic, experimental, immune, hormonal or endocrine therapy
* Prior T-DM1 therapy
* History of exposure to cumulative doses of select anthracyclines
* History of intolerance or hypersensitivity to trastuzumab, murine proteins, or any of the excipients, that resulted in trastuzumab being permanently discontinued
* Brain metastases that are untreated or progressive or currently require any type of therapy, including radiation, surgery, and/or steroids to control symptoms from brain metastases within 30 days before the first study treatment
* Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, at the time of the first study treatment
* History of clinically significant cardiac dysfunction
* Current known active infection with HIV, hepatitis B virus, or hepatitis C virus
* Current severe, uncontrolled systemic disease
* Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment
* Pregnancy or lactation

NOTE: The site selection process has been completed. Patients can enroll at participating sites.
Blending Two Worlds: Traditional Aboriginal Healing Strategies for Depression and Anxiety

1. Purpose

   1. Provide a culturally sensitive and supportive treatment environment for children, youth and families in the aboriginal community experiencing stress, anxiety and depression.
   2. Gain insight into understanding of the role of Traditional Healing options provided by Aboriginal Healers and Helpers in the management of stress, anxiety and depression.
   3. Encourage Aboriginal and First Nation clients to seek treatment earlier from a culturally supportive system.
2. Hypothesis

This will be a descriptive hypothesis generating research project, however it is anticipated that members of the Aboriginal community experiencing stress, anxiety and depression may experience improved care and outcomes if their treatment includes traditional healing methods. A number of measures of subject and treatment characteristics, stress, anxiety and depression will provide the foundation for triangulation of outcomes in order to describe the impact of the various treatment options (standard care, Traditional Healing, combined standard care and Traditional Healing).

Aboriginal clients, including first nation youth, may not be confident or comfortable with the standard treatments offered by the current Mental Health environment. Incorporating traditional aboriginal healing methods such as dream work, energy healing, healing circles, pipe ceremonies, self care, smudging, sweat lodge and traditional learning into standard practice will provide a culturally sensitive and supportive environment for children, youth and families experiencing stress, anxiety and depression.

It is believed that Aboriginal and First Nation clients that access treatment options consistent with cultural beliefs will be encouraged to seek treatment earlier and will experience improved care and outcomes.

In addition, the improved understanding of the role of traditional healing methods provided by Aboriginal Healers and Helpers in the management of these disorders will help clinicians incorporate these practices in the management of anxiety and depression

Eligibility Criteria:
Inclusion Criteria:

* children and adolescents (less than 18 years of age)and families with anxiety and/or depression attending the Surrey North Child and Youth Mental Health Team.

Exclusion Criteria:

* Subjects with severe anxiety or depression requiring intervention (i.e. hospitalization) or have a past or present history of suicide attempt. Subjects with special needs including medical contraindications (i.e. medical conditions including pregnancy), brain injury, developmental disability or fetal alcohol syndrome). Those subjects unwilling or unable to participate in a Traditional Healing options.
Ischemic Memory Imaging With Myocardial Contrast Echocardiography

The overall aim of this study is to determine whether non-invasive imaging with myocardial contrast echocardiography using can provide information on the presence and spatial extent of recent myocardial ischemia by non-invasive echocardiographic imaging.


Eligibility Criteria:
NORMAL CONTROL GROUP

Inclusion Criteria:

* Normal control individuals

Exclusion Criteria:

* History of cardiovascular disease (coronary artery disease, MI, peripheral artery disease)
* allergy to eggs or ultrasound contrast agents
* known or detected right to left shunt
* presence of a wall motion abnormality
* pregnancy

ACS GROUP

Inclusion Criteria:

* Patients with diagnosis of acute coronary syndrome with either unstable angina or non-ST-elevation MI
* Referred for primary percutaneous intervention
* At least 1 high risk features (ST changes, positive troponin, wall motion abnormality)

Exclusion Criteria:

* allergy to eggs or ultrasound contrast agents
* hemodynamic instability or shock
* known or detected right to left shunt
* pregnancy
* multivessel CAD requiring multivessel PCI
A National Registry on Chinese Patients With Lymphangioleiomyomatosis

Pulmonary lymphangioleiomyomatosis (LAM), a disease characterized by diffuse cystic changes in the lung, is a rare disorder that affects almost exclusively women. The main objectives of this study are to accurately evaluate the prevalence of LAM, the status of disease, the diagnosis and treatment, the quality of care, and the health related outcomes in China.

Pulmonary lymphangioleiomyomatosis (LAM), a disease characterized by diffuse cystic changes in the lung, is a rare disorder that affects almost exclusively women. The main objectives of this study are to accurately evaluate the prevalence of LAM, the status of disease, the diagnosis and treatment, the quality of care, and the health related outcomes in China. This is a register study lasting 4 years, aims to raise 800 subjects. Primary endpoint is the annual change of forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) in pulmonary function tests.

Eligibility Criteria:
Inclusion Criteria:

1. Gender: female.
2. Age: no limitation.
3. Diagnosis meets one of the following criteria, (1) definite or probable diagnosis of LAM based on ATS/JRS and ERS criteria. (2) Investigators recommend including of the patient.

Exclusion Criteria:

1. Suspected LAM patients without other supporting evidence for LAM diagnosis.
2. No diffuse cystic lesions in the lung.
3. Patients with bilateral cystic lung lesions but the LAM diagnosis cannot be established.
4. Without signed informed consent.
5. Difficult to follow up.
Comparison of Botulinum Toxin Injection Techniques in Spasticity

The aim of the study is to compare the effectiveness of the classical (2-4 points to the muscle proximal) application of botulinum toxin in the treatment of spasticity with the application along the length of the gastrecnemius muscle.

The main question it aims to answer Is botulinum toxin more effective in the treatment of spasticity than the classical application applied along the length of the gastrocnemius muscle? Participants will be evaluated for spasticity before and 1 month after injection.

Researchers will compare classical versus application along the length of the muscle to see if there is a reduction in spasticity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with spastic hemiplegia
* Spasticity in the gastrocnemius muscle

Exclusion Criteria:

* Those who have spasticity in other muscles that will affect ankle movements
* Those who use myorelaxant or myospasm-effective drugs
* Those who have been applied botulinum toxin in the last 3 months
* Those who have contractures in the ankle and knee due to orthopedic reasons.
Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis

1. Registry of demographic, clinical, endoscopic and histological data at baseline.
2. Registry of patients treated with PPI:

   * Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
   * Clinical, endoscopic and histological response at 6 and 12 months weeks of maintenance treatment
3. Registry of patients treated with two foods elimination diet:

   * Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
   * Identification of food trigger: milk, gluten or milk and gluten
   * Clinical, endoscopic and histological response at one year elimination of food trigger
   * Registry of adverse events
4. Registry of patients treated with swallowed steroids (budesonide or fluticasone):

   * Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
   * Clinical, endoscopic and histological response at 6 months of maintenance steroid treatment
   * Registry of adverse events


Eligibility Criteria:
Inclusion Criteria:

* Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis (EoE) according to the recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus \> 15 eos / CGA)
* And that they need to start treatment with any of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids .

Exclusion Criteria:

* Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis)
* Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).
Efficacy of Ben-Guard Garment in Reducing Pediatric Central Line Complications

Central venous catheter (CVC) insertion is a common surgical procedure performed in children for the delivery of nutritional support, medications, frequent blood draws or transfusions. Maintaining hygienic conditions is absolutely necessary in order to avoid contamination of the catheter and tubing to avoid bloodstream infections. Fractures in the tubing is a common complication that places children at increased risk for infections. In order to help keep the tubing stable to avoid fractures and dislodgements, a wearable device was created called Ben-Guard. This pilot study is being undertaken to determine if the Ben-Guard device will reduce the incidence and severity of adverse events in children requiring CVCs.

Conduct a pragmatic pilot study of the Ben-Guard Catheter Safety Device in 40 pediatric patients with central venous catheters (CVC). Participants will be issued 3-5 garments, which are expected to be worn at all times. This study will be conducted over an 18 month period. Participants are expected to wear the garment daily for the duration of the study (or duration of their treatment if \<18 months). Data will be reviewed every 3 months to measure the garment's acceptability and effect on the frequency of central line-associated complications. Outcomes will be compared to a matched retrospective cohort. This study will use the device consistent with the description as a registered FDA Class 1 device. The investigators are conducting this study to clinically and scientifically evaluate the device's ability to change the frequency of CVC fractures and CVC complications in children.

Eligibility Criteria:
Inclusion Criteria:

* Participants age 0-10
* medical disease or condition that requires a CVC for treatment, supportive care or nutritional support
* English Speaking

Exclusion Criteria:

* Any patient who received a non-tunneled CVC
* Any patient who had a tunneled CVC placed from an outside institution
* Age \> 10
* Patients that cannot communicate or read English