cyrilzakka/clinical-trials huggingface dataset:
Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) is a kind of chronic bronchitis or emphysema with characteristics of long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Anatomically, the pulmonary bronchus structures in COPD patients are damaged and cannot be repaired by recent clinical treatment so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to investigate whether bronchial basal cells can regenerate damaged lung tissue. During the treatment, bronchial basal cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, cultured cells will be transplanted autologously into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 40 to 75;
* Diagnosed with COPD according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by FEV1\<70% predicted value and FEV1/FVC \< 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by CT or blood examination.);
* Clinically stable for more than 4 weeks;
* Tolerant to bronchofiberscope;
* Written informed consent signed.

Exclusion Criteria:

* Pregnant or lactating women;
* Patients positive for syphilis, HIV;
* Patients with malignant tumor;
* Patients with serious significant pulmonary infection and need anti-infection treatment;
* Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
* Patients with a history of abusing alcohol and illicit drug;
* Patients participated in other clinical trials in the past 3 months;
* Patients assessed as inappropriate to participate in this clinical trial by investigator.
LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery

The preclinical data have demonstrated the feasibility of fluorescence-guided tumor resection by the Cancer Vision Googles (CVG) with LS301 in animal models. In this study, the investigators will conduct intraoperative imaging procedures that have minimal interference with ongoing surgery. The underlying hypothesis is that the accurate detection of all cancer cells highlighted by LS301 during surgery will reduce the number of patients with margin positivity to less than 5%, compared to the current surgical paradigm of greater than 15% in pancreatic cancer, for example. The pilot study will obtain critical data required to address the larger question of surgical margin assessment in a full Phase I clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with gastrointestinal cancers, including pancreas, liver, gastric cancer, gastrointestinal stromal tumors, and metastatic cancers undergoing surgical resection as standard of care treatment.
* At least 18 years of age.
* For the first cohort of patients enrolled, must have an ECG with no prolonged intervals.
* Able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Contraindications for surgery.
* Receiving any investigational agents.
* History of allergic reactions attributed to ICG or other agents used in the study, include known iodide or seafood allergy. We do not expect many of these adverse reactions with LS301 because it is not radioactive and does not possess iodinated counterions.
* Presence of underlying lung disease.
* Pregnant. Female patients of childbearing potential must have a negative serum or urine pregnancy test no more than 7 days before start of participation.
* Breastfeeding. Patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LS301.
Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation

Endometriosis is a common benign disease in premenopausal women and causes chronic pelvic pain and infertility. This infertility may be due to pelvic adhesions and surgery but also because of poor oocyte quality. It is known that endometriosis is associated with an increase oxidative stress, wich induce chronic inflammation, deleterious effect for DNA, proteins and can caused cellular death. ROS markers found in follicular fluid or in serum are significatively higher in endometriosis women. The investigators want to dose a marker of apoptosis in infertile women and see if it's significatively higher in serum and in follicular fluid of patients with endometriosis compared to others infertility causes and if it's correlated to oocyte quality and IVF results. Real time PCR will be used to dose cell free DNA in serum and follicular fluid of patients undergoing IVF treatment (endometriosis and infertility due to tubal factor, male infertility or idiopathic cause). Then the investigators will compare cell free DNA rate with oocyte and embryo quality and with pregnancy outcomes in the different group.


Eligibility Criteria:
Inclusion Criteria:

* patients eligible medical assistance to procreation who are about to undergo IVF treatment
* aged between 18 and 43 years old
* and who have signed a consent form

Exclusion Criteria:

* patients who are not eligible for medical assistance to procreation,
* patients who are followed for other inflammatory disease,
* patients followed for premature ovarian failure or
* patients with a recent story of pelvic infection
A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia

This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>=18 years of age;
* Chronic renal anemia;
* No ESA therapy during previous 3 months.

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months;
* Poorly controlled hypertension requiring hospitalization in previous 6 months;
* Significant acute or chronic bleeding.
Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)

The purposes of the study is to determine the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating Myelodysplastic Syndrome patients.

This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Decitabine). Patients in experimental group will receive hUC-MSC, while control group receive placebo (normal saline), four weeks as a course of treatment. All of the patients accept examination before treatment, including

* diagnostic projects: bone marrow test, peripheral blood classification, chromosome, and MDS fusion gene test, etc.;
* routine examination: blood, urine, and stool routine test, X-ray film in chest, electrocardiogram, etc.;
* stem cell-based medicinal products usage, dosage, time, and course of treatment.

Then, patients will accept routine examination everyday, and after treatment, investigator will follow-up for 6 months, to evaluate the security and efficacy of hUC-MSC.

Eligibility Criteria:
Inclusion Criteria:

* MDS patients with international prostate symptom score is moderate or severe symptoms

Exclusion Criteria:

* with serious renal function impaired
* with other organ function abnormal: acute hepatitis B, ejection fraction \< 40%, serum bilirubin \> 3mg/dl, liver function tests abnormal, central nervous system disease, mental disease
* bad physical condition (Karmofsky \< 60%)
* without signing informed consent form
* under other therapy that possibly influence MSC security or efficacy
* HIV or other serious disease infection
* Donor: HIV, active hepatitis B/C infection, Syphilitic antibody positive
* Donor/ participants: alcoholism, drug addicted, mental disease
A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood

2 different formulations of tafamidis will be compared under both fed and fasted conditions. Subjects will be fasted overnight or fed. After swallowing one of the tafamidis formulations, tafamidis blood concentrations will be measured periodically for 8 days. After 16 days, subjects will take a different formulation in the fed or fasted state or take the same formulation in the opposite feeding condition. This will be repeated, 16 days apart, until all subjects have taken each formulation both fed and fasted.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females of non-child bearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria:

* Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
* Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
* Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.
Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)

This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.

This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.

The main objective of the study is to assess the feasibility and safety of home-based tDCS for patients with MDD.

The treatment course will consist of an acute phase of 28 tDCS sessions, conducted daily (7 days per week) over 4 weeks.

Thereafter, participants will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:

1. Three tDCS sessions applied once every other day.
2. Three tDCS sessions applied once every third day.
3. Three tDCS sessions applied once every fourth day.

Eligibility Criteria:
Inclusion Criteria:

1. Major Depressive Disorder
2. Age \>=18
3. Currently experiencing a major depressive episode of at least four weeks' duration
4. MADRS score at least 20 at trial entry.
5. Taking at least one approved antidepressant medication (except bupropion).
6. Has a healthcare provider, and a companion who can help administer study treatments; and be able to connect frequently with study staff
7. Access to wireless internet (wifi) connection

Exclusion Criteria:

1. Any psychotic disorder.
2. Concurrent benzodiazepine medication.
3. High suicide risk
4. History of significant neurological disorder.
5. Skin lesions on the scalp at the proposed electrode sites.
6. Pregnancy.
7. Any antidepressant medications will be permitted (except bupropion) provided the medication dose has been unchanged for 4 weeks prior to trial entry.
8. Any cranial metal implants (excluding ≤1 mm thick epicranial titanium skull plates and dental fillings) or
9. Medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator);
10. Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
11. Substance use disorder (including alcohol) within the past year.
Radiofrequency Ablation of Papillary Thyroid Microcarcinoma

Traditionally, surgery has been the standard recommendation for treating papillary thyroid cancer. The risk of surgery including permanent hoarseness, permanent hypocalcemia, a mid-cervical scar, and the potential for permanent hypothyroidism may be unacceptable for some patients, especially with low risk papillary thyroid carcinoma. The recent American Thyroid Association guidelines have proposed the option of active surveillance with low risk papillary thyroid cancer less than 210 mm. However, most patients find observation anxiety provoking knowing of having cancer. Radiofrequency ablation (RFA) of small low risk papillary thyroid cancer is a promising therapeutic modality for these patients that reduces the risks associated with surgery and the anxiety of taking a watchful approach. However, this technique has not been validated in the North American population.

The investigators aim to describe the investigators' initial experience with RFA of low risk papillary thyroid microcarcinoma (PTMC) compared to active surveillance (AS) done by Head and Neck Endocrine surgeons at Johns Hopkins Medical Institute.

Primary objective:

* To evaluate the safety, efficacy and oncological outcomes of the procedure.

Secondary objective:

* To determine the patient functional outcomes in comparison to the observational control.


Eligibility Criteria:
Inclusion Criteria:

* All patients regardless of sex or race between the ages 18-100 with biopsy proven PTMC with a Bethesda V or VI pathology or indeterminate cytology on fine-needle aspiration cytology (FNAC) who are recommended for treatment (Bethesda III/IV).
* Solitary thyroid nodule \<20mm in maximal dimension.
* No sonographic evidence of extrathyroidal invasion, lymph node metastases, or distant metastases.
* There must be at least 1 mm of normal tissue as a margin, without sonographic evidence of contact with the capsule.

Exclusion Criteria:

* Patients with other histological types of thyroid malignancy other than papillary thyroid cancer such as medullary carcinoma, Proto-oncogene serine/threonine kinase (BRAF) or Telomerase reverse transcriptase (TERT) mutations
* Clinically apparent multicentricity
* Lesions larger than 20 mm in maximum diameter.
* Recurrent laryngeal nerve palsy.
* Extension of nodule to posterior thyroid capsule.
* Ultrasound or other imaging studies revealing cervical lymph node involvement or distant metastases.
* Pregnancy.
* Pacemaker.
* Previous RFA.
SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)

A Phase 2 open-label, single-arm, non-randomized study in the treatment of advanced hepatocellular carcinoma (HCC) patients who failed prior treatment with sorafenib using a Simon's 2-stage design. A set minimum number of patients must demonstrate disease control at 16 weeks to proceed to Stage 2. At Stage 2, a set number of patients must have disease control at 16 weeks to declare that SGI-110 is of interest in the treatment of advanced HCC after failure of prior sorafenib.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Histological or cytological confirmed hepatocellular carcinoma with advanced stage disease
3. Received prior sorafenib treatment, and showed evidence of disease progression, which is defined as Investigator verified radiologic progression, or intolerance of prior systemic therapy, which is defined as having had clinically significant adverse events that persisted despite one or more dose reductions or interruptions
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
5. Acceptable organ function
6. Signed an approved informed consent

Exclusion Criteria:

1. Known hypersensitivity to SGI-110
2. Adequate washout of prior radiation, chemotherapy or other locoregional therapy
3. Abnormal left ventricular ejection fraction
4. Uncontrolled ischemic heart disease or a history of congestive cardiac failure
5. Known brain metastases
6. Clinically evident ascites
7. Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points
8. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, non-metastatic prostate cancer with normal prostate-specific antigen (PSA) or other cancer from which the subject has been disease free for at least three years
9. Known history of human immunodeficiency virus (HIV)
Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples

Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples. In many other types of surgery, surgical incisions are closed with a super-glue called Dermabond. The researchers at the University of Massachusetts believe Dermabond may be a safe alternative to using staples at the time of a cesarean delivery, but this has not been studied. Women who choose to participate will be randomly assigned to have the cesarean delivery skin incision closed with staples or Dermabond. The researchers will survey the patients to see how they felt about the experience and the appearance of their scar. The researchers will survey physicians performing the surgery to see how easy Dermabond was to use. The researchers will ask physicians to evaluate the appearance of the incision after a 6-week recovery period and will analyze complications (such as bruising, infection, or separation of the wound) in the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women undergoing scheduled and non-scheduled cesarean deliveries

Exclusion Criteria:

* Prisoners
* Insulin-requiring diabetics
* Vertical skin incision
* Allergy to Dermabond
Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants

Preterm infants are at risk to develop nephrocalcinosis. Incidence numbers vary according to birth weight and gestation age. Very low birth weight infants have the highest risk index, with \~ 7-10 % of preterm infants developing nephrocalcinosis in the patient population. We, the researchers at the University of Cologne, and others found significantly decreased urinary citrate excretion (hypocitraturia) to be one of the main risk factors. Hence, we hypothesized, that prophylactic treatment with oral alkaline citrate solution (Shol's solution) would help to 1) increase urinary citrate excretion and 2) help to decrease the incidence of nephrocalcinosis.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \< 32 weeks gestation age and \< 1500 g birth weight

Exclusion Criteria:

* Cardial, renal or gastrointestinal malformations
* Chronic renal failure
* Therapy with vitamin B6
* High dose treatment with furosemide or dexamethasone
* Addison's disease
* Severe metabolic alkalosis
* Worse clinical condition of preterm infant, which makes oral feeding impossible
* Participation in other studies
Validity and Reliability of the Turkish Version of the Pectus Carinatum Evaluation Questionnaire for Patients With Pectus Carinatum

Based on the hypothesis that the chest wall was still pliable in adolescence and could be reshaped in a normal position with the external suppressor applied on the chest, a pressure orthosis was started to be used in the pectus carinatum. It is the focus of attention as it is an alternative method to surgery for patients. However, the patient's compliance with the orthosis is difficult. Therefore, in our study, we aimed to investigate the Turkish Validity and Reliability of the Pectus Carinatum Evaluation Questionnaire, which is a questionnaire investigating the compliance with orthosis treatment in patients diagnosed with Pectus Carinatum by the doctor.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been diagnosed with Pectus Carinatum by a doctor, have an orthosis indication (2 cm above the protrusion level) and who are given the orthosis for the first time
2. Having a correction pressure below 10 pounds per square inch (PSI) in the compression test
3. Between the ages of 10-18,
4. Having dissatisfaction with this defect

Exclusion Criteria:

1. Having severe scoliosis (Cobb angle over 20 degrees)
2. Having chronic systemic disease
3. Having a serious psychiatric illness
4. Having complex mixed type pectus deformity
Utility and Validity of a High-intensity, Intermittent Exercise Protocol

The purpose of this study is to identify an exercise-induced fatigue protocol to mimic central and peripheral acute fatigue effects associated with participation in vigorous dynamic sports activities and to understand the expected central (cardiovascular) and peripheral (muscular) impact of this protocol.

Fatigue-related parameters (BORG, heart rate, blood lactate level, concentric/eccentric force of the quadriceps muscle) will be measured before and after different short-term high-intensity, intermittent exercise protocols.

Eligibility Criteria:
Inclusion Criteria:

* Men
* ≥ 18 years
* Volley- and basketball, non-elite
* ≥ 3 times per week sports participation
* No acute or overuse low back/lower extremity injuries in the past 6 months

Exclusion Criteria:

* Women
* \<18 years
* \>45 years
* other sports than volley- and basketball
* elite players
* \<3 times per week sports participation
* acute or overuse low back/lower extremity injuries in the past 6 months
Conversion Rate of (TST) Tuberculin Skin Test and Quantiferon-TB Gold In Tube Assay in Health Care Workers

The purpose of this study is to access conversion rate of TST (Tuberculin skin test) and Quantiferon-TB Gold In tube assay in health care workers.


Eligibility Criteria:
Inclusion Criteria:

* age 20-75, men and women
* participant who was enrolled in the study of latent tuberculosis in health care worker (IRB No.4-2009-0187)
* high risk or low risk health care worker who was performed TST or Quantiferon-TB Gold In tube assay before

Exclusion Criteria:

* age \< 20
* person who don't agree with enrollment
* illiterate
* person who is diagnosed as active tuberculosis now
* person who has history of hypersensitivity on PPD (tuberculin purified protein derivative)
* pregnant woman
* person who is treated as active tuberculosis