cyrilzakka/clinical-trials huggingface dataset:
Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy

This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.

Primary Objectives

* Bone Marrow Function: To report on the incidence, timing, severity of, and risk factors for bone marrow dysfunction in participants in remission or without bone marrow involvement of disease at 3- and 6-months following CAR T cell therapy. (B-ALL cohort)
* Infection/Immune Reconstitution: To evaluate the incidence, timing, severity of and risk factors for clinically significant infections following CAR T cell therapy at 3- and 6-months following CAR T cell therapy. (B-ALL cohort)
* Neurotoxicity: To evaluate the incidence, timing, severity of, and risk factors for persistent ICANS at 3- and 6-months post CAR T cell therapy. (B-ALL cohort)

Secondary Objectives

* To evaluate bone marrow function, infection/immune reconstitution, and neurotoxicity at 12 months and 24 months post CAR T cell therapy in participants with B-ALL.
* To characterize bone marrow function, infection/immune reconstitution, and neurotoxicity between 3 and 24 months after CAR T cell therapy in other hematologic malignancies and solid tumor cohorts.

Participants will have an assessment of preexisting morbidity and potential risk factors, collection of specimens for banking, scheduled late effects monitoring, laboratory analysis, and screening studies. Data and biospecimens will be collected at 3 months, 6 months, 1 year and 2 years after CAR T cell infusion.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have received an initial systemically-administered CAR T cell infusion within the last 1-3 months (+/- 14 days).

  * Initial infusion is defined as the first administration of a CAR T cell product the participant has not previously received OR receipt of a CAR T cell product previously received after an interval allogeneic HSCT.
* Age ≤ 30 years at CAR T cell infusion.

Exclusion Criteria:

* Active malignancy other than the disease under study.
* Planned consolidative HSCT within 3 months post CAR T cell infusion.
* Received or planned additional disease directed therapy post CAR T cell infusion.
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Interactive Cholesterol Advisory Tool

The purpose of this study is to show that we can effectively deliver health information and education, online, via computer regarding cholesterol. This computer program is called the Interactive Cholesterol Advisory Tool (ICAT).

Participants will be recruited and categorized based on screening labs into 1 of 2 groups: Low or moderate risk of developing cardiovascular disease within 10 years based on risk factors. The low risk group will be advised to take the blood test results furnished by the study to their primary care doctor to discuss managing cholesterol. The moderate risk group will see the study physician for 4 visits about high cholesterol. Both groups complete a total of 4 blood draws over 9 months. Both groups will be randomized at consent into 2 groups: 1 who uses the Interactive Cholesterol Advisory Tool (ICAT) and 1 that does not use the ICAT. Because recruitment goals for the low risk group were met, a third group was created: low risk who both the study physician for 4 visits about high cholesterol and use the ICAT.

Eligibility Criteria:
Inclusion Criteria:

* Fluency in English,
* Willing to come in for 1-5 visits,
* Low and moderate CVD risk.
* Having access to a computer with internet connection

Exclusion Criteria:

* CVD diagnosis or CVD equivalent,
* Psychosis, terminal illness,
* Pregnancy,
* Current statin use if assigned to the low risk group
* Liver disease,
* Peripheral Vascular Disease,
* Diabetes Mellitus,
* Abdominal Aortic Aneurism,
* Cerebral Vascular Disease
* Triglyceride level above 500 mg/dl
* Uncorrected hypothyroidism
Second STOP After Pioglitazone Priming in CML Patients

Single-center study, prospective, phase II trial.

The study objectives are :

* To assess safety and pharmacokinetics of the combination of PIO and TKI in CML subjects who experience a loss of MMR following a first TKI discontinuation.
* To assess survival without loss of MMR over a 12 months period following a second TKI discontinuation in subjects who achieve or maintain \< MR4.5 with the combination PIO and TKI administered for at least 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. CML in any phase. patient in MR4
2. Loss of MMR following a first or subsequent TKI discontinuation trial.
3. Patient prior treated with imatinib, dasatinib, nilotinib, or bosutinib
4. Age \>18 years.
5. Serum bilirubin \<1.5 x upper limit of normal values.
6. AST (SGOT)/ALT (SGPT) \<2.5x upper limit of normal values.
7. Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative urine pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device, transdermal/implanted or injected contraceptives and abstinence.
8. Males must agree to abstain from sexual activity or agree to utilize a medically-approved contraception method during and for 3 months after the treatment period.
9. Signed informed consent.
10. Be able and willing to comply with study visits and procedures

Exclusion Criteria:

1. Known loss of CCyR by marrow cytogenetic or blood FISH for BCR-ABL1.
2. Loss of CHR.
3. Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment.
4. Prior allogeneic hematopoietic stem cell transplantation.
5. Patient requiring anti-diabetic medications to manage hyperglycemia.
6. Cardiovascular disease: history of congestive heart failure, myocardial infarction within the 6 months of study entry, symptomatic cardiac arrhythmia requiring treatment.
7. Hepatic insufficiency
8. History of bladder cancer.
9. Diagnosed hematuria.
10. Known osteoporosis with curative therapy (prophylactic therapy is not an exclusion criteria)
11. Known history of macular edema.
12. Known history of ABL1-domain mutation associated with resistance to the discontinued TKI.
13. Known allergy to PIO.
14. Pregnant or breastfeeding.
15. Use of TZD within 28 days prior to enrollment.
16. Significant gastrointestinal condition that could potentially impair the absorption or disposition of the drug.
17. Uncontrolled peripheral edema (2+ or more) of any etiology
Prospective Study of the Influence of the Diffuse Noxious Inhibitory Controls of the Pain on the Efficacy of Milnacipran in Fibromyalgia Therapy

Fibromyalgia affects 0.7 to 3.3% of the adult population and 7-10 times more women than men. In France, the prevalence is 1.6% according to a French study conducted in 2009 and published in 2011 by Serge Perrot et al.

The definition of fibromyalgia was recently amended with particular consideration of cognitive and somatic symptoms, factors not involved in the initial criteria of the ACR classification. Several factors are in favor of a malfunction of the central modulation of pain and poorer performance noxious inhibitory controls descendants (DNIC: diffuse noxious inhibitory controls) have been demonstrated. In fibromyalgia patients, the DNIC (diffuse noxious inhibitory controls) are altered with less pain inhibition than controls. Dysfunction of the central pain modulation is widely described in the literature and contributes to pain complained of fibromyalgia.

According to the Recommendations of the European League Against Rheumatism (EULAR) 2006, antidepressants have a genuine analgesic efficacy in controlled studies. Milnacipran is an antidepressant known and used in major depressive disorder according to its marketing authorization but is also part of the molecules used in the treatment of chronic neuropathic pain and fibromyalgia according to the recommendations of the EULAR. A review included five double-blind studies on 4,000 participants who took 100 mg or 200 mg milnacipran or placebo over a period of 8 weeks to 24 weeks. A moderate response was obtained for 40% of participants treated for each dose of milnacipran on the criteria of "at least 30% pain relief" Impression and global change. Substantial improvement with milnacipran compared to placebo has been shown.

To date, the link between the weakening of DNIC in fibromyalgia and effectiveness of drug treatment has not been shown.

This study aims to assess the degree of impairment of DNIC in fibromyalgia patients may be predictive of the efficacy of milnacipran.

Visit 1 Inclusion of the patient, Clinical examination, Evaluation of pain, basal Pain and cognitive tests

Visit 2 (can be coupled with Visit 1 if necessary) Randomisation of the patient and allocation of the treatment for 1 month.

Phone contact Visit 2 +7 days, + 15 days, +21 days Follow-up of the compliance of the treatment and collection of adverse events.

Visit 3 (follow up at 1 month) Evaluation of pain, Pain and cognitive tests End of study

Eligibility Criteria:
Inclusion Criteria:

* Patient of more than 18 years old,
* Patient with fibromyalgia

Exclusion Criteria:

* Patient with a contraindication to the administration of the milnacipran,
* Patient with a concomitant spontaneous pain not attributable of fibromyalgia,
* Patient with medical and/or surgical histories judged by the investigator not compatible with the trial.
Dietary Factors and Risk of Gallbladder Carcinoma in China

The purpose of this study is to see how people's diets, other aspects of their lifestyles affect their chances of getting gallbladder carcinoma in China. This survey will enroll 100 patients who have had gallbladder carcinoma，as well as controls with gallstones. The investigators will compare these two groups of subjects to see what factors may lead to gallbladder carcinoma.

The investigators will conduct a case-control study in 10 hospitals from China. Cases will be the patients with newly-diagnosed gallbladder carcinoma. The controls will be matched （1：1）by sex，race and age which will be selected from the patients receiving cholecystectomy due to gallstones from the same hospital with the cases.

There will be 100 cases with gallbladder carcinoma, 100 controls. The investigators will interview participants about known and potential risk factors for gallbladder carcinoma and obtain information on diet. The investigators will obtain the blood and urine samples for further analysis of metabolomics studies. The investigators will use logistic regression to determine odds ratios for disease with various exposures.

Eligibility Criteria:
Inclusion Criteria:

Diagnosed with gallbladder carcinoma by imaging tests (cases) Diagnosed with chronic cholecystitis by imaging tests (hospital controls)

Exclusion Criteria:

The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases
Efficacy of Probiotics on Iron Status During Pregnancy

Determine the effect of probiotics on improving iron status in a population of healthy, pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, pregnant women, aged 18-42 years, with a singleton gestation
* Inclusion at 10-12 weeks of gestation
* BMI ≥ 18 and ≤ 30 at baseline
* Provide signed and dated informed consent form
* Willing to comply with all study procedures

Exclusion Criteria:

* Serum ferritin level \<20 µg/L or Hb\<110 g/L at baseline (visit 1)
* Chronic diseases associated with anemia
* Known Thalassemia
* Hyperemesis gravidarum
* Chronic gastrointestinal disease (inflammable bowel diseases; Crohn's disease, Ulcerative Colitis; diarrheal disease)
* Known gluten intolerance, lactose intolerance, milk protein allergy
* Taking antibiotics within four weeks before inclusion
* Blood or plasma donation within three (3) months prior to baseline
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* Smoking or use of nicotine-containing products (currently or during the last three \[3\] months)
* History of alcohol abuse, or excessive intake of alcohol, as judged by the Investigator
* Hypersensitivity to any of the ingredients in the study products
* Any other reason for exclusion, as judged by the Investigator
Bioequivalence Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochloride Tablets Under Fasting Conditions.

Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22 days.

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of FDC of Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Tribenzor® 40+10+25 mg Tablets containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg (Reference , Daichi Sankyo Inc, USA.) in Healthy Human Volunteers Under Fasting Condition.

Eligibility Criteria:
Inclusion Criteria:

* Sex: male
* Age: 18-45 years
* Volunteer with BMI of 18-25 (inclusive both) kg/m2
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Preferably Non-smokers

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 110 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 70 mm Hg or more than 90 mm Hg.
* Pulse rate less than 60/minute or more than 100/minute. Oral temperature less than 95°F or more than 99°F.
* Respiratory rate less than 14/minute or more than 18/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Comparisons of Novel Double-lumen Endobronchial Tube for Blind Lung Isolation Technique With Conventional Double-lumen Endobronchial Tube in Patients Undergoing One-lung Ventilation

The study is prospectively conducted on 190 patients aged between 20 and 85 years, American Society of Anesthesiologists (ASA) physical status I - III, undergoing one-lung ventilation for thoracic surgery. Patients were randomly allocated into either control group (n = 95) or experimental group (n = 95) by a computerized randomization table. The size of endobronchial tube is decided based on the diameter of left main bronchus measured on the CT finding of patients. After induction of general anesthesia, in patients assigned to control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endobronchial tube (Shiley®, Covidien, Mansfield, MA, USA). In experimental group, patients are intubated with novel double-lumen endobronchial tube (Ankor®,Insung Medical, Wonjou, S. Korea). During intubation, the carina cuff of Ankor® is inflated after the tube is rotated 90º toward the left. The tube is advanced until slight resistance is felt, then the carina cuff is deflated. In both groups, fiberoptic bronchoscope is performed to evaluate the position of endobronchial tube after intubation. If endobronchial tube is not in optimal position, the depth of tube is corrected to optimal position under guidance of fiberoptic bronchoscope. Airway injury is confirmed using fiberoptic bronchoscope before extubation. The success of endobronchial intubation, position of endobronchial tube, the corrected depth of endobronchial tube, time consumption for endobronchial intubation and complication of intubation such as airway injury, pain, and hoarseness are compared between two groups.


Eligibility Criteria:
Inclusion Criteria:

1. ASA classification 1-3
2. aged between 20 to 85
3. undergoing one lung ventilation using left-sided double-lumen endobronchial tube for thoracic surgery

Exclusion Criteria:

1. Expected difficult intubation (neck extension\<35 degrees, mandibular-hyoid distance \< 6 cm, sternomental distance \< 12.5 cm)
2. anomaly of tracheobronchial tree
3. intraluminal lesion in left or right bronchus
4. Obesity (Body Mass Index \> 30)
5. upper respiratory infection
6. Thoracic surgical history
7. blood coagulation disorder
8. emergency operation
Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making

This is a prospective randomized control trial to compare the impact of two different types of pre-operative web-based breast cancer information on the quality of patient decision making. Patients are emailed web-based information prior to the surgical consultation. Outcomes are assess at multiple time points: 1) prior to the surgical consultation, 2) immediately following the consultation.


Eligibility Criteria:
1. \>18 years of age
2. Newly diagnosed stage 0-3 breast cancer
3. English speaking
4. Has an email address
5. No prior recent contact with the breast surgeon
Touch on One Thumb, RSI on the Other Thumb: Which Surgery Shows Better Results

The study aims to determine whether CMC I arthroplasty using a Touch® implant results in higher patient satisfaction compared to RSI arthroplasty in the medium-term in patients with primary thumb osteoarthritis. Additionally, the study compares the patients' clinical and self-reported outcomes between the Touch® implant and the RSI arthroplasty. Therefore, patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb will be recruited.

Patients suffering from osteoarthritis in the first carpometacarpal joint (CMC I OA) are often surgically treated with a resection-suspension-interposition (RSI) arthroplasty. An alternative technique is an arthroplasty with a Touch® implant. There is a growing body of evidence indicating that patients with a Touch® prosthesis recover significantly faster and return to work more quickly than patients after an RSI arthroplasty. However, there have been no studies comparing the two operations in the same patient. By recruiting patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb, this study aims to investigate whether CMC I arthroplasty using a Touch® implant leads to higher patient satisfaction compared to RSI arthroplasty in the medium-term. Further patient-reported and clinical outcomes will be assessed to compare the two surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the patient.
* Patient is diagnosed with primary OA in both CMC I joints and was operated with a Touch® prosthesis on one thumb and with an RSI arthroplasty on the other thumb.

Exclusion Criteria:

* Patient with any type of revision surgery at the CMC I joint
* Patient underwent hand surgery within the last three months
* Legal incompetence
Assessing the Effect of Periodontal Debridement, Tongue Cleaning and Mouth Rinsing for the Treatment of Oral Malodour

This study evaluates the short and long term effect of dental cleaning and mouthrinsing for the treatment of bad breath

The majority of bad breath producing bacteria can be found in pockets around the gums and the top of the tongue. It is generally agreed that one of the most effective means of controlling the production of bad breath gases from these bacteria is their mechanical removal. Tongue cleaning has shown consistent results in the reduction of bad breath, while dental cleaning has shown positive, but less conclusive results. The addition of a mouth rinse to mechanical measures has shown medium-term effectiveness, however there is currently no information available that describes the long-term impact of mechanical and chemical measures for the treatment of bad breath and the appropriate interval for follow-up and on-going management to prevent difficult cases.

Eligibility Criteria:
Inclusion Criteria:

Organoleptic score of 2 or more, and volatile sulfur compound score of greater than 1.5ng/10ml of hydrogen sulfide and 0.5ng/10ml of methyl mercaptan

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Exclusion Criteria:

* Moderate to severe periodontal disease, systemic illness or dental disease associated with halitosis, antibiotic use in the past month, need for antibiotic prophylaxis for dental procedures and current smokers