cyrilzakka/clinical-trials huggingface dataset:
National Marrow Donor Program (NMDP)

To serve as a focal point for bone-marrow research.

BACKGROUND:

In 1986, the Department of the Navy initiated the National Bone Marrow Donor Registry. Because the support of a National Bone Marrow Donor Registry was not very closely related to the Navy's primary missions, in 1989 the management of the contract for the program was transferred by the Congress from the Navy to the NHLBI.

By 1989, bone marrow transplantation had become an effective and accepted treatment for an increasing number of diseases of the bone marrow and the immune system. Until only a few years prior to 1989, most marrow donors were siblings, carefully matched for HLA (tissue) antigens. Since only a small proportion of candidates for a bone marrow transplant have matched brothers or sisters, additional family members were tried as donors. These included parents, children, slightly mismatched siblings, and other relatives. Even with the broadening of the bone marrow donor source, no more than 30-40 percent of patients with diseases amenable to marrow transplant therapy had available donors. Improved results with these selectively mismatched relatives and a distinct need to provide appropriate treatment for more patients led to trials with unrelated, HLA-matched community volunteers as bone marrow donors. By 1989, research had progressed to the point where transplants from such unrelated donors were nearly as successful as those from matched siblings, when stratified by disease status and risk parameters. In 1989, 20 to 25 percent of patients for whom a formal donor search was initiated received a transplant. This was expected to increase substantially.

DESIGN NARRATIVE:

The program was established by the Department of the Navy in 1986 and transferred to the NHLBI in 1989. The purpose was to develop and maintain a registry of individuals willing to donate bone marrow for patients in need of transplants, to facilitate marrow transplants by serving as a coordinating and communications center for a network of donor, collection and transplant centers in the United States and internationally, and to facilitate research into the efficacy of unrelated donor marrow transplants. In 1992, the program was enlarged to support a limited number of demonstration projects to develop, implement, and evaluate innovative models for minority marrow donor recruitment. In 1995, the NMDP was transferred to the Health Resources and Services Administration (HRSA), although NHLBI provided funds in this year.

Eligibility Criteria:
No eligibility criteria
Safety and Superiority of Penicillamine in Radiosensitization of Recurrent Head and Neck Cancer

Our preclinical study confirmed that copper accumulation can lead to radioresistance in vitro and in vivo, and reducing the concentration of copper with copper chelator help to overcome radioresistance. Therefore, the investigators plan to carry out a prospective interventional phase II clinical trial to explore the safety and efficacy of penicillamine (a common copper chelator) as a radiosensitizer in the treatment of recurrent head and neck cancer.

Head and neck cancer is the sixth most common cancer worldwide. Radiotherapy is an important measure to control tumor recurrence. Although radiotherapy has been widely used in patients with head and neck cancer, the 2-year local recurrence rate of patients with locally advanced disease is still as high as 50%-60%. This is associated with a lower radiosensitivity in head and neck cancer. High doses of reirradiation (\>60 Gy) are associated with severe late complications and treatment-related mortality. Therefore, finding an appropriate sensitizer to improve the radiosensitivity is the key to improve the survival of recurrent patients. Our preclinical study confirmed that copper accumulation can lead to radioresistance in vitro and in vivo, and the results were published in J Hepatol (IF=25.7). Penicillamine is a commonly used copper chelator in clinical practice and can reduce the concentration of copper in the body. Based on this, the investigators plan to carry out a prospective interventional phase II clinical trial to explore the safety and efficacy of penicillamine as a radiosensitizer in the treatment of recurrent head and neck cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Sign informed consent
2. The age is 18-75 years
3. Previously received standard radical radiotherapy or chemoradiotherapy
4. Head and neck tumors with in situ or cervical lymph node recurrence confirmed by pathological biopsy and imaging examination
5. ECOG PS：0/1
6. Laboratory examination confirmed good organ function, which should be carried out within 10 days before the first treatment.

Exclusion Criteria:

1. After evaluation, it does not meet the indications of re-radiotherapy
2. Unable to take oral medication
3. Pregnancy or lactation
4. Known allergy to penicillamine
5. Patients who are judged by the researcher as unsuitable to participate in this trial.
Conservative Treatment for Atypical Endometrial Hyperplasia and Early Endometrial Cancer

Exploring the efficacy and pregnancy outcomes of conservative treatment for atypical endometrial hyperplasia and endometrial cancer. Study the factors related to predicting treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

* (1) age ≤ 45 years old, strong desire to preserve reproductive function, and no factors of reproductive dysfunction evaluated before treatment; (2) The pathological type is atypical endometrial hyperplasia or endometrial cancer; (3) Imaging examination confirmed that the tumor was localized to the endometrium; (4) There are follow-up conditions available.
Return to Work After Hand Injury: the Role of Medical, Demographic and Psycho-Social Factors

The purpose of this study is to investigate the extent of return to work (RTW) after traumatic hand injury and to identify factors that are related to RTW.

RTW is one of the main rehabilitation outcomes after injury, the loss of the ability to work may have psychological as well as economic impact on the injured person. Time off work is also a burden to the economic system, associated with loss of work days, sick leave and national insurance payment. Hand injury can cause limitations in function, therefore influence the ability to work. Review of the literature reveals that time off work after hand injury ranges from a few days to a year and more. Factors associated with time off work include medical, socio-economic and psychosocial factors. Only a few studies have been conducted in Israel to investigate rate of RTW after hand injury and factors that affect RTW . The aim of this study is to explore the extent of RTW after traumatic hand injury and to examine the relationship between several factors - medical, demographic and psychosocial and RTW. This, in order to identify prognostic factors that can be treated during rehabilitation. There is no preliminary hypothesis made about the relationships between the factors and RTW. This study is also retrospective and prospective since it examine individuals under-going occupational therapy treatment and individuals who have been treated in the past.

Eligibility Criteria:
Inclusion Criteria:

* The individual worked until he/she was injured
* Traumatic hand injury including: wrist fractures, fingers fractures, tendon injury, nerve injury, Crush injury, finger amputation

Exclusion Criteria:

* Non traumatic hand injury (such as CTS)
* Mallet finger
* Burns
* Injury in several organs
Use of miRNAs in Growth Hormone Deficiency (GHD)

This study aims at improving knowledge about the diagnosis of growth hormone deficiency (GHD) and treatment with growth hormone (GH), with the goal of providing information on the presence of new biomarkers, such as miRNAs, for diagnostic and therapeutic purposes, with the goal of establishing a personalized GH treatment scheme, optimizing resources, reducing costs, and improving outcomes.

In 200 prepubertal and pubertal subjects with the suspicion of GHD, the levels of three specific circulating miRNas will be measured to establish whether they can be used for the diagnosis of GH deficiency. In subjects with isolated idiopathic GHD (IIGHD), short statured patients born SGA, Noonan and Turner syndromes, and SHOX deficiency, we will also assess the changes of the identified miRNAs before and after 3 months on GH therapy to verify an early growth prediction model for growth response at 12 months on treatment. Finally, we plan to identify any differences in these miRNAs at 3 months on treatment using daily GH versus weekly (long-acting) GH.

Eligibility Criteria:
Inclusion Criteria for aim 1:

* Children with short stature and suspicion of GHD
* Subjects with organic GH deficiency

Exclusion criteria for aim 1:

-Subjects with underlying genetic conditions and chronic diseases

Inclusion Criteria for aim 2-3-5:

* patients having confirmed GHD enrolled for aim 1
* patients with growth failure and born SGA (\>4 yr of age)
* patients with Noonan and Turner syndrome and growth failure
* patients with short stature homeobox-containing gene deficiency (SHOXD) and growth failure

Inclusion Criteria for aim 4:

- Isolated idiopathic prepubertal naive GHD subjects on long-acting versus daily GH therapy
A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction

To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered for 6 (±1) days.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had undergone an uncomplicated ACL reconstruction procedure and were in satisfactory health were included in the study
* In addition, they needed to have a baseline pain intensity of ≥ 50 mm on the VAS and "moderate to severe" pain on the categorical scale within 8 hours of the completion of the surgical procedure to be included

Exclusion Criteria:

* Patient was scheduled to undergo any other surgical procedure, along with the orthopedic procedure, that was expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
* The patient was undergoing bilateral knee arthroscopy
* The patient used conventional NSAIDs, COX-2 inhibitors, or Tramadol during the 6 hours preceding surgery, during surgery or subsequent to the end of surgery, until randomization
* The patient received oxaprozin or piroxicam within one week prior to randomization
* The patient was required to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics and neuroleptics, in the post operative period after the patient was randomized into the study
* The patient had been treated with patient controlled analgesia subsequent to the end of the surgical procedure
Musculoskeletal Imaging of Runners

The investigators aimed to assess the impact of long-distance running on musculoskeletal system of runners, by doing high resolution magnetic resonance imaging analysis before and after marathon running.

Rationale for the study: This research will examine a key modifiable risk factor for health and well- being: exercise. Regular exercise is highly recommended by healthcare professionals because the whole body benefits, including cardiorespiratory, musculoskeletal systems and mental wellbeing. Long-distance running is a popular physical activity with more than 30 million individuals running marathons each year. The increasing participation of first-time runners, including older people, has been linked to a rise in related injuries. The ideal dose of exercise is not known and overdosage affects some musculoskeletal tissues and joints more than others. Overdoing a specific amount of exercise and the presence of chronic injuries may pose a great risk on the joints, leading to serious conditions such as osteoarthritis, musculoskeletal injuries, tendinopathy. However, it is not yet clear whether a high dose of exercise such as marathon running damages the musculoskeletal system and there is a growing need for research in the area of running science to better understand this.

Aim: This research aims to do musculoskeletal imaging before and after long-distance running using 3 Tesla magnetic resonance imaging and to provide evidence on how much exercise people should undertake and how to minimise injury.

Eligibility Criteria:
Inclusion Criteria:

* no previous marathon participations
* no present or previous history of hip injuries or surgeries
* asymptomatic hip joints
* no contradindications to hip MRI scanning

Exclusion Criteria:

* pregnant or breastfeeding women
* individuals aged \<18 years
* claustrophobia
* history of anxiety or panic attacks
* known hip problems
A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.

The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.

The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-two (22) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by a two week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication up to 4 grams per day of acetaminophen (paracetemol) will be allowed.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.

Exclusion Criteria:

* Subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms.
* Any other condition that will cause a risk to subjects if they participate in the trial is also a reason for exclusion.
Trastuzumab in Treating Women With Metastatic Breast Cancer

RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying the side effects of trastuzumab in treating women with metastatic breast cancer.

OBJECTIVES:

Primary

* To evaluate the predictive value of genetic factors on the toxicity and efficacy of a trastuzumab-based therapy in women with metastatic breast cancer.

Secondary

* To analyze tumor factors potentially related to the efficacy of trastuzumab (i.e., expression of proteins involved in cell proliferation and survival).

OUTLINE: This is a multicenter study.

Patients receive standard treatment with trastuzumab. Blood is collected periodically for pharmacogenetic analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer

  * Metastatic disease, defined by the existence of a secondary tumor localization radiologically (i.e., by radiography, CT scan, MRI scan, or ultrasound) or scintigraphically confrimed
* Evaluable disease
* Beginning first-line metastatic treatment with trastuzumab (Herceptin®) with or without chemotherapy
* Primary tumor must overexpress HER2 (IHC 3+ OR IHC 2+ and FISH+ OR FISH+)
* Hormone receptor status not specified
* No brain metastasis

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Life expectancy \> 3 months
* Able to undergo cardiotoxicity evaluation every 4 months by measuring LVEF via an isotopic method or ultrasound with systematic registration
* No chronic uncontrolled disease
* No heart failure
* No respiratory failure or hypoxemia
* No history of another primary cancer except for basal cell carcinoma of the skin
* No severe uncontrolled infection
* No psychological incapacity

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Trial on Use of Coloshield in Transanal and Anal Surgery

In various transanal and anal procedures it is desirable to clean the operating field from stool contamination. Thus mechanical bowel preparation is not well tolerated by patients. Enema does not provide sufficient effect. By the use of Coloshield a rectal washout might be performed and enable a clean operating field. In this randomized controlled trial the macroscopic contamination of the rectum with and without Coloshield is compared using the Boston Bowel Preparation Score (0-3).


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery for Fistula-in-ano, transanal resection of rectal Polyp or Adenoma, haemorrhoids or anal fissure.

Exclusion Criteria:

* Age \<18 years
* inability to give informed consent
* pregnancy
* missing informed consent
* emergency Operation (\<24hours of diagnosis and admission at emergency room)
* rectal strictures or Stenosis
* status post rectal resection or pelvic Radiation therapy
* inflammatory bowel disease with inclusion of the rectum
* need for mechanical bowel preparation
Study of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma

This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti CD22 CAR NK cells in patients with relapsed refractory B cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. CD19 (+) B cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry
2. Previously accepted ≥ first-line regimen chemotherapy
3. Unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation
4. Over 18 years old and under 70 years old
5. The expected survival period is more than 3 months.
6. ECOG≤2
7. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no abnormal electrocardiogram; blood oxygen saturation ≥90%; creatinine clearance ≥40 mL/min; ALT and AST≤3 times normal range, Total bilirubin ≤ 2.0 mg / dL;
8. Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L;
9. The pregnancy test for women of childbearing age must be negative; both men and women must agree to use effective contraception during the treatment period and for the following 1 year.
10. Measurable target lesion

Exclusion Criteria:

1. Patients with extra-medullary relapse
2. Burkitt's lymphoma/leukemia
3. Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19 treatment;
4. Liver and kidney function:

   Total bilirubin \> 2 × ULN (Gilbert Syndrome \> 3 × ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 3 × ULN Serum creatinine clearance \>60 mL/min
5. Serological examination:

   Absolute neutrophil count (ANC) \<0.75×109/L Platelet count (PLT) \<50×109/L
6. Active hepatitis B (HBV-DNA \> 1000 copies / mL), hepatitis C, or uncontrolled infection
7. GVHD ≥ 2 or anti-GVHD treatment
8. IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before infusion, such as donor lymphocyte infusion;
9. Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks
10. Active CNS disease (tumor cells in CSF, but \< 5 WBCs/mL can be included);
11. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation
12. Creatinine \> 1.5 times normal upper limit or ALT / AST \> 3 times normal upper limit or bilirubin \> 2 times normal upper limit
13. New York Heart Association (NYHA) graded above or above
14. Uncontrollable diabetes
15. Suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining
16. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results
D-Lung: An Analytics Platform for Lung Cancer Based on Deep Learning Technology

Lung cancer is one of main cause of cancer death in worldwide, characterized of low 5-year survival rate of less than 20%. Pulmonary nodule is considered as the typical imaging manifestation in early stage of lung cancer. The National Lung Screen Trial has demonstrated that the mortality rates could decline greatly, by the utility of low-dose helical computed tomography for screen of pulmonary nodules. Thus, automatic detection, diagnosis and management of pulmonary nodules, play the vital roles in computer-aided lung cancer screening and early intervention.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with suspicious lung nodules.
* Thin-layer thoracic CT and pathology examination have been performed for suspicious lung nodules.

Exclusion Criteria:

* Subjects with accompanied lesions on CT images that may interfere to lung nodules analysis
Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure

The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves exercise capacity, physical functioning and quality of life in patients with iron deficiency and chronic heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
* Reduced exercise capacity
* Reduced left ventricular ejection fraction
* At least 18 years of age and with written informed consent prior to any study specific procedures

Exclusion Criteria:

* Erythropoietin stimulating agent (ESA) use, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomisation
* Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
* Chronic liver disease and/or elevated liver enzymes
* Vitamin B12 and/or serum folate deficiency
* Subject is not using adequate contraceptive precautions during the study
* No other significant cardiac or general disorder that would compromise participation in the study