cyrilzakka/clinical-trials huggingface dataset:
Effects of Cervical Spine Manipulation on Gait

The purpose of the study is to see if manipulation of the neck will change the way people who may or may not have neck pain, walk under differing conditions.

Volunteers in this study will be asked to do the following: 1) complete a series of questionnaires about health status and undergo physical screening of neck to make sure that manipulation will not be harmful; 2) walk in socks or bare feet across a computerized mat under 3 conditions - normal walking pace, walking while looking up and down repeatedly; and walking while looking left and right repeatedly; 3) have one of 2 manual therapy interventions to the neck; 4) repeat the walking across the computerized mat under those same 3 conditions.

The 2 randomly assigned interventions are: cervical manipulation, or cervical contact. If assigned the manipulation, volunteers will lie face up and the trained therapist will move the joints in the neck in a gentle, but short and sharp manner which may produce a slight 'pop' or 'click'. If volunteers are assigned the cervical contact, they will lie on their back and the trained therapist will gently hold the head and neck for 45 to 60 seconds as they quietly relax.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteers may or may not have mechanical neck pain
2. Aged 18 to 70 years
3. If neck pain is present, must have Neck Disability Index score of at least 10 out of 50 points

Exclusion Criteria:

1. 'Red flag' items indicated in Neck Medical Screening Questionnaire such as history of a tumor, bone fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc.
2. History of neck whiplash injury
3. Diagnosis from physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms
4. Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes
5. Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck)
6. Prior surgery to neck or upper back
7. A medical condition which may influence assessment of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency)
8. Diagnosis from your physician of fibromyalgia syndrome
9. Currently pregnant, or could be pregnant
A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer

Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers. Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, CAR-T cells persistence, tumor elimination and disease status after treatment will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Relapsed or refractory HER2 positive cancer.
2. KPS\>60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 18 years to 80 years.
5. Assessable lesions with a minimum size of 10mm by CT scan or MRI.
6. Acceptable organ function

   Hematology:
   * Absolute neutrophil count greater than 800/mm\^3 without the support of filgrastim.
   * White blood cell (WBC) (\> 2000/mm\^3).
   * Platelet count greater than 50,000/mm\^3.
   * Hemoglobin greater than 9.0 g/dl.

   Chemistry:
   * Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 3 times the upper limit of normal (patients without liver metastasis) or 6 times the upper limit of normal (patients with liver metastasis).
   * Serum creatinine less or equal to 3 times the upper limit of normal
   * Total bilirubin less than or equal to 3 times the upper limit of normal.
7. No other serious diseases(autoimmune disease, immunodeficiency etc.).
8. Adequate cardiac function(LVEF≥40%).
9. No other tumors.
10. Patients volunteer to participate in the research.

Exclusion Criteria:

1. Allergic to cytokines.
2. Uncontrolled active infection.
3. Acute or chronic GVHD.
4. MODS.
5. Treated with T cell inhibitor.
6. HIV affected.
7. Other situations improper for the research.
External Comparison of Ibalizumab in Trials vs. Other Regimens in OPERA

Among heavily treatment experienced people living with HIV, the virologic effectiveness of ibalizumab + optimized background regimen from two clinical trials will be compared to non-ibalizumab-containing regimens in routine clinical care in the OPERA cohort.

The US Department of Health and Human Services (DHHS) HIV treatment guideline suggest that ibalizumab may be considered in the context of multidrug resistance without fully active ART options. However, clinical trials assessing ibalizumab efficacy did not include an active comparison arm in which participants did not receive ibalizumab. The use of external controls can provide valuable information and context to interpret the results of clinical trials when randomization to a control arm cannot be performed.

The OPERA (Observational Pharmaco-Epidemiology Research \& Analysis) cohort, a large US electronic health record database, is well suited for this as the OPERA and trials populations arose from the same geographic location (i.e., US). An external comparison of ibalizumab + optimized background regimen from trials vs. non-ibalizumab containing regimens in routine clinical care in the OPERA cohort may confirm results from prior studies suggesting viral control benefits of ibalizumab.

Eligibility Criteria:
Inclusion Criteria (Trial IBA+OBR group):

* Participant in TMB-202 or TMB-301/311
* Received 800 mg IBA every 2 weeks, with or without a loading dose

Inclusion Criteria (OPERA non-IBA OBR group):

* HIV-1 infection
* 18 years or older
* Heavily treatment experienced (i.e., ever on a regimen containing either DTG BID or DRV BID)
* Documented resistance to ≥1 ARV from each of three ARV classes
* Genotype information available for all the relevant gene regions (see Table 2)
* Viral load \> 200 copies/mL at index regimen initiation
* Not pregnant at index
* No new AIDS defining event within 3 months before/on index (except cutaneous Kaposi's sarcoma or HIVAW)
* No new cancer diagnosis within 12 weeks before/on index
* No IBA prescribed prior to/with the index regimen
* Index regimen does not include cabotegravir, fostemsavir, investigational drugs
* Viral sensitivity/susceptibility to at least one ARV in the index regimen
* Baseline VL available (within 6 months before/at index)
* Baseline CD4 available (within 6 months before/at index)
* ≥1 VL measurement at any time after index
Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

This study evaluates post-operative pain between different insufflation pressures during robotic-assisted sacrocolpopexy. Subjective pain and narcotic usage after surgery will be measured.

This is a prospective single-blind randomized controlled trial of adult women undergoing robotic-assisted sacrocolpopexy for pelvic organ prolapse. Each surgery will be performed by a board-certified Female Pelvic Medicine \& Reconstructive Surgery (FPMRS) surgeon with a standard technique other than pneumoperitoneum level. A sacrocolpopexy for apical prolapse may be performed at the same time as a hysterectomy and other clinically indicated procedures if desired by the patient and as part of the standard of care. Patients will be stratified by hysterectomy prior to randomization. Postoperatively, patients will be evaluated with a Visual Analogue Scale (VAS) as well as prescribed narcotic analgesic use and followed up to 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to have a robotic-assisted sacrocolpopexy surgery for pelvic organ prolapse.
* Age 18-90 years
* Can read and understand the consent form and consents to the procedure

Exclusion Criteria:

* Patients undergoing other procedures
* Patients who do not consent to participate.
Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From MGUS and SMM.

The purpose of this study is to describe DNA copy number variations and gene expression profiles of bone marrow plasma cells of monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). The final objective is to search for correlations with the risk of progression in order to establish a predictive model of early malignant transformation.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 18 to 70 years
* Written informed consent
* One of the following three criteria:

  * Recently diagnosed IgG or IgA monoclonal gammopathy without clinical or biological features of malignant hemopathy
  * IgG or IgA MGUS regardless the date of the diagnosis
  * SMM regardless the date of the diagnosis
* Normal blood count, creatininemia and calcemia \*
* Bence-Jones proteinuria below 1g/24 hours
* Absence of bone pain
* No clinical or biological features of amyloidosis
* No recurrent episode of infection (more than 2 infections requiring antibiotics in the previous 6 months) \* In case of abnormal blood count, renal failure or hypercalcemia, patients may be included if an intercurrent cause is identified (for example anemia associated with iron deficiency)

Diagnostic criteria for MGUS:

* Monoclonal component concentration below 30 g / l AND
* Bone marrow plasmacytosis below 10%
* Bence-Jones proteinuria below 1g/24 hours
* Normal blood count, creatininemia and calcemia \*
* Absence of bone lesions on conventional bone radiographies
* No clinical or biological features of amyloidosis
* Absence of hyperviscosity syndrome
* No recurrent episode of infection (more than 2 infections requiring antibiotics in the previous 6 months) \* In case of abnormal blood count, renal failure or hypercalcemia, patients may be included if an intercurrent cause is identified (for example anemia associated with iron deficiency)

Diagnostic criteria for SMM:

* Monoclonal component concentration greater than 30 g / l AND / OR
* Bone marrow plasmacytosis greater than 10%
* Bence-Jones proteinuria below 1g/24 hours
* Normal blood count, creatininemia and calcemia \*
* Absence of bone lesions on conventional bone radiographies
* No clinical or biological features of amyloidosis
* Absence of hyperviscosity syndrome
* No recurrent episode of infection (more than 2 infections requiring antibiotics in the previous 6 months) \* In case of abnormal blood count, renal failure or hypercalcemia, patients may be included if an intercurrent cause is identified (for example anemia associated with iron deficiency)

Exclusion Criteria:

* Patients younger than 18 years
* Patients older than 71 years
* IgM monoclonal gammopathy (regardless of diagnosis)
* Monoclonal gammopathy associated with hematologic malignancies (multiple myeloma, chronic lymphocytic leukemia, ...)
* Patients with chronic liver disease, autoimmune or neoplastic disease for less than 5 years
* Active viral hepatitis B or C
* HIV seropositive patient
* Pregnant woman
* Breastfeeding woman
Evaluation of the Duration of Oral Combination Therapy in Type 2 Diabetes, Prior to the Initiation of Insulin in the UK

Carry out the cost-effectiveness analysis of rosiglitazone on a population in line with the rosiglitazone license and using UK costs


Eligibility Criteria:
Inclusion Criteria:

* Rosiglitazone Type II Diabetes studies

Exclusion Criteria:

* Studies without the required outcome
Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have advanced breast cancer.

OBJECTIVES:

* Determine the toxicity, including cardiac toxicity, of doxorubicin HCl liposome and trastuzumab (Herceptin) in women with advanced HER-2/neu-overexpressing breast cancer.
* Determine the efficacy of this regimen in these patients.

OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven breast cancer

  * Metastatic disease OR
  * Locoregional relapse following optimal adjuvant therapy and regional treatment
  * HER-2/neu overexpression (3+ by immunohistochemistry OR gene amplification by FISH)
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 10 g/dL

Hepatic:

* SGOT and SGPT no greater than 3 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2 times ULN unless documented to be arising from bone
* Bilirubin no greater than 1.5 times ULN

Renal:

* BUN less than 1.5 times ULN
* Creatinine less than 1.5 times ULN

Cardiovascular:

* LVEF normal by radioisotope method
* No history of congestive cardiac failure, myocardial infarction, cardiac arrhythmia, or ischemic heart disease requiring medication

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No known sensitivity to benzyl alcohol
* No other prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Biologic therapy:

* Not specified

Chemotherapy:

* No prior doxorubicin greater than 240 mg/m2

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior radiotherapy to left breast or chest wall allowed

Surgery:

* Not specified
Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer

This is a interventional clinical trial to assess the efficacy and safety of combinational therapy of paclitaxel-albumin and S-1 for the neoadjuvant chemotherapy of advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. pathologically diagnosed gastric adenocarcinoma
2. Type II and III esophageal-gastric-junction malignancy
3. AJCC stage II-III
4. No contraindications for surgery, radical resection can be expected
5. KPS\>60; ECOG score:0-2
6. Expactant survival period\>6 months
7. Age 20\~75
8. No other major health issues
9. Lab results within 7 days before inclusion must satisfy:

   1. neutrophil≥1.5×109/L
   2. PLT≥100×109/L
   3. hemogloblin≥90g/L
   4. ALT,AST\<1.5 upper limit
   5. Tbil≤1.0×UNL
   6. serum creatinine\<1.5×UNL
   7. PT-INR/PTT\<1.7 upper limit
10. with measurable lesion according to RECIST1.1 criteria
11. with consent
12. co-operative

Exclusion Criteria:

1. with other major health issue
2. allergic to relevant drugs
3. experienced any other drug therapy with 4 weeks before inclusion
4. experienced any drug therapy for gastric cancer at anytime
5. diagnosed with any other malignancy within the past 5 years
6. women at child-bearing age; pregnant or breast-feeding women
7. with severe heart disease
8. with upper GI digestion or disrupted absorption
9. with peripheral neural disease
10. with transplated organs or organs having been resected for transplantation
11. known DPD deficiency
12. with uncontrolled infection
Evaluation of the Effects of Duloxetine on Norepinephrine

The purpose of this study is to evaluate how taking duloxetine 60mg every day affects the transfer of two normal body chemicals, 3,4-dihydroxyphenylglycol (DHPG) and norepinephrine (NE), across cells in blood and cerebrospinal fluid.


Eligibility Criteria:
Healthy subjects between the ages of 18-65 years are nonsmokers or are willing to refrain from smoking and are not taking concomitant medications which may inhibit or induce CYP1A2 or CYPD6 or is an MAOI.
Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone

Background: In perioperative period inhibition of N-Methyl-D-Aspartate receptor prevents opioid-induced hyperalgesia and reduce postoperative opioid requirement after abdominal surgery. Methadone is both a µ-opioid receptor agonist like Morphine and a N-Methyl-D-Aspartate antagonist. Study Aim. To evaluate the efficacy of intraoperative Ketamine and postoperative Methadone analgesia in preventing opioid-induced hyperalgesia after abdominal surgery.

not desired

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing open colo-rectal surgery

Exclusion Criteria:

* ASA status more than II, history of chronic pain, ischemic heart disease or chronic pulmonary disease, allergy to any drugs used in the protocol. Body Max Index more than 35.
Tissue and Hematopoietic/Mesenchymal Stem Cell for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer

The overall goal of this study is to develop a pre-clinical platform of melanoma and head and neck squamous cell cancer that will allow the investigators to learn more about these diseases and discover better and more individualized treatments.

The main objective of this study is to establish a humanized animal model. Investigators will consent patients who have melanoma and head and neck squamous cell cancer (HNSCC) and agree to take part in this research study. They will obtain peripheral hematopoietic stem cells (HSC), blood and tumor tissue at baseline from blood and tumor samples from these patients for use in establishing tumor explants in humanized mice. Therapy results on humanized mice will be correlated with existing or newly acquired efficacy results from those same immune-based or other therapies in patients. A secondary objective is to identify pharmacodynamic markers associated with each drug and biomarkers for evidence of efficacy or lack of thereof. Where possible, subjects receiving therapy with FDA-approved drugs of interest will be asked to provide sequential blood and tumor biopsies to study the molecular and immune events that may occur as a result of drug therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy proven incurable melanoma or incurable HNSCC amenable to have biopsy and/or surgical resection of either the primary and/or locoregional metastatic site, at the University of Colorado Hospital.
2. Age ≥ 21 years old per NCI/NIH guidelines
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0. 1, or 2
4. Adequate bone marrow, hepatic and renal function:

   * Absolute neutrophil count ≥ 1,500/µL.
   * Platelets ≥ 100,000/µL.
   * Hemoglobin ≥ 9.0 g/dL.
   * Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min.
   * Total bilirubin ≤ 1.5x ULN.
   * Aspartate Aminotransferase (AST)/Alanine Aminotransferase ( ALT) ≤ 2x ULN.
5. Measurable disease according to Response Criteria in Solid Tumors (RECIST) version 1.1.
6. O2 saturation ≥= 93% at room air.
7. Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

1. Contraindication (absolute or relative) to granulocyte colony-stimulating factor (G-CSF) filgrastim usage:

   * known hypersensitivity to E coli-derived proteins' filgrastim, or any other component of the product.
   * Sickle cell disorders.
   * Clinically significant and active lung hemorrhagic or inflammatory disease, including but not limited to chronic obstructive pulmonary disease (COPD), autoimmune disease, and alveolar hemorrhage; or hypoxemia of any etiology requiring oxygen.
   * Clinically significant splenomegaly or splenic metastases; history of splenic rupture, recent splenic trauma or other clinically significant splenic disease that increases the risk of splenic rupture.
2. Clinically significant and active malignancy other than incurable melanoma or head and neck squamous cell cancer.
3. Known hepatitis B or C, or HIV.
Predictors of Neuro-cognitive Decline and Survival in HIV-infected Subjects

Patients will be followed every 6 months for a total of 5 visits (Month 0, 6, 12, 18 and 24). The first visit is the screening and entry visit which can occur at any time after the subject finishes SEARCH 001 study but preferably it should occur approximately 6 months after SEARCH 001 study completion.

At each visit, patients will undergo the following

1. Assessment of function including activity of daily living questionnaire
2. History of medical illnesses, medication history
3. Neurological examination: All patients will have a neurological evaluation and neuropsychological evaluation to characterize neurocognitive and neurological status. (It is possible that patients within the non-dementia group will meet criteria for dementia after close testing is completed).
4. Neuropsychological assessment:
5. Thai Depression Inventory.
6. HIV viral load and storage of blood for proviral DNA level

Final outcome assessment based on all available data. If possible, it is intended that these diagnoses will be determined through monthly VTC conference calls with UH investigators. This consensus conference will include the Thai investigators, the UH neurologist, the UH neuropsychologist and the UH principal investigators.


Eligibility Criteria:
Inclusion Criteria:

* All patients who have completed the SEARCH 001 study are eligible to enroll in this SEARCH 001.1 study provided that they understand and voluntarily sign the informed consent form.

Exclusion Criteria:

* None
An Assessment of the Glider Balloon in Complex Lesions

The purpose of this study is to collect data from real-world use with the Glider Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the effectiveness of the Glider PTCA Balloon for crossing into complex coronary lesions.

Observational Study collecting data on commercial cases in which the Glider PTCA Balloon Catheter is used in accordance with the instructions for use. This study includes up 500 patients at up to 50 study sites.

Eligibility Criteria:
Inclusion Criteria:

1. Lesion must be successfully crossed with a guidewire without complication (including Chronic Total Occlusions (CTOs))
2. The Glider balloon may only be used at one lesion during the procedure
3. The lesion in which the Glider balloon is used must be completed first
4. The primary lesion treated during the procedure must be treated with the Glider balloon
5. Intended treatment of a protocol-defined complex lesion that has at least one of the following factors:

   * Significant vessel tortuosity
   * Failed balloon crossing with another balloon
   * Tight stenosis
   * Heavy calcification
   * Side branch present

Exclusion Criteria:

1. Patient \< 18 years of age
2. Lesion longer than 40mm
3. Device use not consistent with Instructions for Use
4. Patient has not given consent for their data to be submitted to this registry
Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia

The purpose of the study is to evaluate the satisfaction level of patients using the Symbicort SMART approach for their asthma management.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma for past 6 months and treated with inhaled glucocorticosteroids for at least 3 months.
* Patients who asthma is classified as uncontrolled or partially controlled as defined by GINA 2006 guidelines.

Exclusion Criteria:

* Patients already on Symbicort SMART treatment.
* Patients who has respiratory tract infection 30 days before study enrolment.