cyrilzakka/clinical-trials huggingface dataset:
Natalizumab in Inclusion Body Myositis (IBM)

Muscle biopsies of patients with Inclusion Body Myositis (IBM) have demonstrated a T-cell predominant inflammatory infiltrate, therefore, new agents targeting T -cell mediated cell death may be a novel treatment for IBM. Such an agent capable of preventing T-cell movement out of the vasculature, such as natalizumab, may be beneficial in IBM patients. Six patients will be recruited to participate in this phase I trial.

This is a phase I open label, non-placebo controlled trial evaluating the safety and efficacy of natalizumab in patients with IBM. Pre and post treatment muscle biopsies including measurements of the degree of inflammation as well as the types of inflammatory cells will be measured. The investigators will also assess quality of life, the inclusion body myositis functional rating score (IBM-FRS), and patient and physician global impression of change. Manual muscle testing and quantitative dynamometry will also be evaluated to see if patient's strength improves.

Patients who are eligible to participate and have signed a consent form will have a muscle biopsy performed at baseline and at the end of the study. Physical and neurological exams, as well as IBM-FRS, safety labs will be conducted and collected at monthly visits. Patients will start natalizumab therapy at 300mg intravenously every 4 weeks for 24 weeks. All study related procedures will be conducted at Phoenix Neurological Associates, as well as all infusions and muscle biopsies

Eligibility Criteria:
Inclusion Criteria:

1. Definite diagnosis of sporadic IBM through previous muscle biopsies
2. Age 21-85
3. FVC\> 50%
4. Muscle function adequate for quantitative muscle testing
5. JC virus negative at screening

Exclusion Criteria:

1. Previous therapy with natalizumab.
2. Treatment with other immunosuppressive agents within the last 12 months
3. Quadriceps strength less than or equal to 2/5 at baseline
4. Known malignancy
5. Pregnancy or breastfeeding
6. History of abnormal laboratory results indicative of any significant medical disease that would preclude the use of natalizumab
7. Any clinically significant infectious illness in the 30 days before enrollment
Neuromuscular Training in Recreational Tennis Players

The aim of this study is to investigate the effect of upper extremity neuromuscular exercise training on throwing performance, upper extremity strength, and endurance in recreational tennis players. In this context, 24 recreational tennis players will be included in the study. Participants will be divided into two equal groups using a simple randomization method. The study group (n=12) will receive progressive upper extremity neuromuscular exercise training twice a week for six weeks before each tennis training session, while the control group will perform only routine warm-up exercises. Both groups will be evaluated twice, once at the beginning of the study and again at the end of the six-week intervention. Throwing performance will be assessed using the Functional Throwing Performance Index (FTPI) and the International Tennis Number Test (ITN). Upper extremity endurance will be evaluated through the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) and Scapula Muscle Endurance Test (SME), while upper extremity strength will be measured using the Health Ball Throw Test (HBT) and the Y Balance Upper Extremity Test (YBUET). Statistical analysis will be conducted using SPSS 24.0 software.


Eligibility Criteria:
Inclusion Criteria:

1. Being between the ages of 18-50
2. Being a recreational tennis player
3. Playing tennis regularly for at least 1 year
4. Playing tennis regularly at least twice a week for the last 6 months

Exclusion Criteria:

1. Playing another sport along with tennis
2. Being a professional tennis player
3. Having a history of any injury and/or surgery affecting the upper extremity
Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer

The purpose of this study is to compare the short-term and long-term efficacies and the safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer.

Based on the results of NSABP(National Surgical Adjuvant Breast and Bowel Project) B27 trial, anthracyclines(A) and Taxanes(T) are most commonly recommended in neoadjuvant chemotherapy of breast cancer.

Pirarubicin is one of anthracyclines and by embedding the DNA double stranded, which inhibits DNA replication and RNA synthesis, thereby impedes the rapid growth of cancer cells.

Docetaxel in one of taxanes and by strengthening the tubulin polymerization, inhibiting of microtubule depolymerization and leading to the formation of stable non functional microtubule bundles, which destroys mitosis of tumor cells.

Eligibility Criteria:
Inclusion Criteria:

* histopathologically diagnosed with stage I-III breast cancers;
* clearly confirmed ER, PR and HER2 statuses;
* the state of axillary lymph nodes was determined through the relevant examination steps (puncture or sentinel lymph node biopsy);
* the patients were not treated with neoadjuvant therapy and surgery.

Exclusion Criteria:

* the patients whose breasts or axillary lumps had received excision biopsy;
* the patients who had severely abnormal organ functions or who could not tolerate chemotherapy,
* the patients with severe concomitant diseases;
* the patients with heart disease or left ventricular ejection fraction (LVEF) \<50%.
Major Failure Rate Assessment of Atraumatic Restorative Techniques Versus Hall Technique in the Management of Decayed Primary Molars in Children Aged 4-6 Years Old

This study is designed to compare major failure rate between ART ( excavation of caries with hand instruments and placing glass ionomer restoration without the use of rotary instruments) versus hall technique ( placing a stainless steel crown on the decayed primary molar without prepartion or caries removal)


Eligibility Criteria:
Inclusion Criteria

* Age: From 4 to 6 years.
* Cooperative children
* Children with no systemic disease, occlusal problems or bad habits.
* Primary molars with vital pulp.
* Class II Caries in primary molars within enamel/dentin.
* Molars in occlusion with the antagonist tooth/teeth.
* Teeth with no developmental anomalies.
* Absence of spontaneous pain and tenderness to percussion.
* Absence of any radiolucency in furcation and/or periradicular regions.
* No pathological and internal/external resorption.

Exclusion criteria:

* Presence of signs and symptoms of necrosis (Fistula, abscess, mobility or furcation involvement).
* Root caries.
* History of Spontaneous pain.
Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection

Laser-assisted intracytoplasmic sperm injection (ICSI) has been suggested as a more effective alterative to conventional ICSI when this method of insemination is indicated for patients undergoing in vitro fertilization (IVF). Laser-assisted ICSI differs from conventional ICSI in that a laser is used to drill a small hole through the hard outer coating surrounding an egg before the injection needle containing a single sperm is inserted into the egg. The hole eliminates compression of the egg that normally occurs with conventional ICSI, and thus may reduce the chance of damage. Laser-assisted ICSI is hypothesized to result in increased egg survival, and perhaps improved embryo quality, compared to conventional ICSI.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of infertility
* Scheduled for IVF with ICSI

Exclusion Criteria:

* Retrieval of fewer than 6 mature oocytes
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis

The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.

Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past.

All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device.

The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer.

The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥18 and \<65 years of age at baseline
* Patients with confirmed diagnosis of ulcerative colitis and who are prescribed etrasimod for moderately to severely active ulcerative colitis as per the product label independently of the decision to enroll a patient in this study.
* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Presence of clinical findings suggestive of Crohn's disease.
* Severe extensive colitis evidenced by:

  1. Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of any kind for UC (eg, colectomy) within 12 weeks.
  2. Current evidence of acute severe UC, fulminant colitis, or toxic megacolon 3. Patients with a stoma or planned UC surgical intervention requiring hospitalization.

     4. Prior/Concomitant Therapy:

  <!-- -->

  1. any previous exposure to etrasimod including participation in the etrasimod clinical program.
  2. any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine or tioguanine) or with any of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist); JAK inhibitors (filgotinib, tofacitinib or upadacitinib) or with any other S1P receptor modulator.
* Not owning a digital device with internet connection and/or not willing to complete health questionnaires on this device or not capable of using the health questionnaire collection tool.
* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.
Spread and Course of COVID-19 Infections

The overall goal is to study the immune response to SARS-CoV-2 infection over the period of one year in the blood of a representative cohort of ETH students/employees.


Eligibility Criteria:
Inclusion Criteria:

* ETH employee or ETH student and their family members living in the same household at the start of the study
* Between 18 and 64 years of age at the start of the study
* Signed informed consent

Exclusion Criteria:

* Age over 64 years at the start of the study
* In quarantine or self-confinement at the start of the study
* Active COVID-19 infection at the start of the study:

  * Diagnosed with a laboratory test
  * Suspected based on typical symptoms such as fever (\>38°C), acute pulmonary ex-acerbation or sudden loss of gustatory taste
* The following medical condition

  * With continuous steroid therapy/ chemotherapy/immunsuppressive therapy
  * In treatment for cancer
  * With severe autoimmune disease
An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults

The objective of this study is to evaluate the safety of chronic use of BLI400 laxative in constipated adults.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects at least 18 years of age
2. Constipated, defined by the following adapted ROME II definition:

   * Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12 months:
   * Straining during \> 25% of defecations
   * Lumpy or hard stools in \> 25% of defecations
   * Sensation of incomplete evacuation for \> 25% of defecations
3. If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
4. Negative urine pregnancy test at screening, if applicable
5. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

1. Report loose (mushy) or water stools in the absence of laxative use for more than 25% of BMs during the 12 weeks before Visit 1
2. Meet the Rome II criteria for Irritable Bowel Syndrome
3. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
4. Subjects who have had major surgery 30 days before Visit 1; appendectomy or cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI tract at any time before Visit 1
5. Subjects with hypothyroidism that is being treated and for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of Visit 1
6. Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of Visit 6
7. Subjects who are pregnant or lactating, or intend to become pregnant during the study
8. Subjects of childbearing potential who refuse a pregnancy test
9. Subjects who are allergic to any BLI400 component
10. Subjects taking narcotic analgesics or other medications known to cause constipation.
11. Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG
12. Subjects with clinically significant laboratory abnormalities, deemed as a potential safety issue by the Investigator, may be discontinued at the Investigator's discretion.
13. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
14. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
15. Subjects with an active history of drug or alcohol abuse
16. Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1
17. Subjects who withdraw consent at any time prior to completion of Visit 1 procedures
Efficacy of Cervical Stabilization Exercises on Hand Grip Strength in Chronic Myofascial Neck Pain

The purpose of this study is to examine effect of cervical stabilization exercises on hand grip strength, key pinch strength, pain intensity, pain pressure threshold and hand function in chronic myofascial neck pain patients.

Myofascial pain of the trapezius is considered one of the main causes of neck pain and characterized by deep, intense pain of the skeletal muscles and their fascia and by the presence of one or more MTrPs, Although MTrPs can be formed in any muscle or muscle group, previous studies concluded that the upper trapezius(UT) muscle is the most commonly affected muscle.

Considering the role of synergistic function of the UT muscle in scapula-humeral rhythm during shoulder movement, it is not surprising that MTrPs in UT muscle can result in shoulder dysfunction and disability. Muscle activity of proximal parts is necessary for activation of distal parts. In fact, the stable activity of distal parts needs controlling the proximal parts. Thus, the stability of shoulder girdle is required for activity of distal parts such as fingers, wrists and elbows. In addition, trigger points in the UT can affect grip strength, which depends on shoulder joint and scapular stability. Thus, UT muscle dysfunction can reduce grip strength.

However, little research has been carried out to determine the therapeutic effects of cervical stabilization exercises on chronic neck pain, and up till now, there is a gap in literature to explore efficacy of cervical stabilization exercises on chronic neck pain and hand grip strength. Therefore, this study aims to investigate whether cervical stabilization exercises has an effect on hand grip strength in chronic myofascial neck pain.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic neck pain for more than 3 months.
2. Active MTrPs in the UT muscle with a tender nodule.
3. Constant neck pain, a jump sign during palpation of UT muscle.
4. Referred pain.
5. Symptoms of ipsilateral hand muscles weakness.

Exclusion Criteria:

1. Signs of severe pathology such as malignancy of the cervical area.
2. Fractures of the cervical spine.
3. Cervical radiculopathy or myelopathy.
4. Diabetes.
5. Trauma, congenital anomalies and surgery around neck, shoulder and hand.
6. Fibromyalgia or vascular syndromes such as vertebra-basilar insufficiency.
7. Pregnancy.
Symptom Support During Chemotherapy: A Mixed Method Study in Adult Patients With Cancer

This study evaluates the value of a nursing symptom support en selfmanagement intervention for adult patients with cancer treated with chemotherapy. Using a prospective sequential design with a comparison group who receives standard care and a (later) intervention group who gets the nursing intervention, we will evaluate the effect of this nursing intervention on overall symptom distress (primary outcome) and other measures of symptom burden, self-efficacy, outcome expectations and self-care. By conducting sem-structured interviews with some participants of the intervention group, we will study the patient experience of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients starting first line treatment with (intravenous) chemotherapy
* Ambulatory patients or patients who receive their treatment during short hospital stays
* Regardless of type of cancer, treatment or treatment intention (curative or palliative)
* Who understand sufficiently Dutch to fill out questionnaires
* Who sign informed consent for their participation in the study

Exclusion Criteria:

* Oral anticancer treatment
* Concomitant chemoradiotherapy
* Breast cancer patients who receive nurse counseling throughout their therapy
* Experimental therapy in the context of a clinical trial
Effectiveness of Central Oncology Navigation and the Use of an ORN

This health services interventional study investigates the effectiveness of central oncology navigation (SOC ) alone and central oncology navigation with a new role called an "oncology research navigator (ORN)" who is embedded in central oncology navigation cancer care delivery. This study will examine two patient cohorts: Cohort 1 will enroll patients with new cancer appointments within genitourinary (GU) or thoracic cancers. These clinics have not yet implemented the central navigation program. Participants will be enrolled pre- and post-implementation of the central oncology navigator within these cancer groups to evaluate the effectiveness of the central oncology navigator alone. The second cohort will enroll participants with new cancer appointments within gastrointestinal (GI), hematology, and breast cancer (clinics where the central navigation program was implemented). These individuals will be randomized to receive standard of care, which for these cancer types includes central oncology navigation or the intervention of an oncology research navigator in addition to SOC. This intervention will involve baseline and biweekly follow-up for a total of 3 months. Interactions with the ORN will include facilitating participation in supportive care services and clinical trials. All participants will undergo baseline and follow-up patient-reported outcomes and data collection. The study will evaluate the impact of the central oncology navigation program alone, as well as the addition of the ORN on patient quality of life, as well as enrollment into studies and participation in supportive care services. Additional analyses will evaluate the impact of the central oncology navigation program on patient experience, patient activation, net promoter scores, and overall survival.


Eligibility Criteria:
Inclusion Criteria:

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

* Informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Subject is willing and able to comply with study activities based on the judgement of the investigator.
* Age ≥ 18 years at the time of consent.
* Subject has a new patient appointment for cancer care at a UNC Medical Center and a confirmed cancer diagnosis.

Exclusion Criteria:

* Lack of internet access.
* Inability to understand the English language.
* Psychological or other disability resulting in the inability to provide informed consent.
Integrating Financial Coaching and Smoking Cessation Coaching

This study conduct a two-arm, parallel-group randomized controlled trial. The study will recruit and randomize 900 smokers (n=450 per arm) to either: (1) Control: Standard Smoking Cessation Counseling or (2) Intervention: Integrated Financial-Smoking Cessation Counseling.

The study is a two-arm, parallel-group RCT. The study will recruit and randomize 900 low-income smokers (n=450 per arm) to either: (1) Control: Standard Smoking Cessation Counseling or (2) Intervention: Integrated Financial-Smoking Cessation Counseling. Both groups will receive 8 weeks of nicotine replacement therapy. The study will survey participants at baseline, 6 months, and 12 months to assess outcomes and mechanisms, and biochemically verify self-reported abstinence at 12 months (our primary outcome). The study will assess and compare the costs and cost-per-quit in the two treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years,
* smokes ≥5 cigarettes per day,
* interested in receiving smoking and financial counseling,
* self-reported income below 200% of the current federal poverty level,
* New York City resident,
* speaks English or Spanish language (the interventions and measures have not been validated in other languages),
* able to provide informed consent, and
* does not have a representative who manages his/her funds.

Exclusion Criteria

* people who know a current past study participant (to avoid intervention contamination)
* People who have a medical contraindication to using nicotine replacement therapy:
* allergy to nicotine patch
* pregnancy or intention to become pregnant over the next 12 months
* breastfeeding
* heart attack in the past 2 months
* underlying arrhythmia
* ongoing or worsening angina.
Effects of Physical Activity on Cardiovascular Risk and Quality of Life

Community intervention trial, randomized, to promote regular PA and social and cultural support activities for 9 months in older-adult primary care users and assess their effects on cardiovascular risk factors and health-related quality of life.

A structured program to promote Physical , according to the recommended guidelines and supervised by healthcare personnel should be deployed to assess their short, medium and long-term effects on CVD risk and Qulity of life. The aim of this study was to evaluate the effectiveness of a program to promote Physical, social and cultural activities for 9 months on cardiovascular risk factors and quality of life among older-adults,

Eligibility Criteria:
Inclusion Criteria:

\* Adults users of 4 Primary Health Care Centers in Catalunya.

Exclusion Criteria:

* Previous episode of ischemic heart disease (\<6 months).
* Outbreak of arthritis with limited ability to ambulate.
* Lung or heart disease with dyspnea mild-moderate efforts.