cyrilzakka/clinical-trials huggingface dataset:
Early Detection of COPD Patients in GOLD 0 (Smokers) Population

Even though the main risk factor for the development of chronic obstructive pulmonary disease (COPD) is smoking only in less than one third of the smokers the clinically manifest COPD will develop. The disease progressive nature with high disability and mortality especially in the final stages makes it plausible to detect the disease as early as possible thus allowing for the early intervention. Major intervention trials in COPD, "Towards a Revolution in COPD Health" (TORCH), "Investigating New Standards for Prophylaxis in Reducing Exacerbations" (INSPIRE), and "Understanding Potential Long-term Impacts on Function with Tiotropium" (UPLIFT) have recently shown that the beneficial impact of intervention was larger in patients being treated in earlier stages of the disease development. Till now the only tool for an early diagnosis and early intervention that could be used on the global scale was spirometry even though symptoms and deprivation of quality of life (QoL) precedes clinically relevant spirometric changes. So there is a need for a new simple tool that would allow detection of patients in a very early stage of COPD.

So the aim of this study is the development of diagnostic tools for an early detection of COPD, even before the significant change in spirometry.


Eligibility Criteria:
Inclusion Criteria:

* Smokers or ex-smokers
* 40-65 years of age
* at least 20 pack-years of smoking history

Exclusion Criteria:

* any clinically relevant chronic disorder with a significant influence on QoL
* immuno-suppressive treatment
* significant acute respiratory disorder during last 4 weeks
* hospitalization during last 3 months
* acute myocardial information, cerebro-vascular infarction or transient ishemic attack during last 6 months
* asthma
* unable to perform the study protocol (diagnostic workout)
Ovarian Tissue Cryopreservation for Fertility Preservation

To provide a novel fertility preservation option for patients facing a fertility threatening cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation program. To determine if ovarian tissue cryopreservation provides women with a useful, successful option for fertility preservation

The hypothesis is that ovarian tissue cryopreservation for fertility preservation provides an alternative option for fertility preservation.


Eligibility Criteria:
Inclusion Criteria:

* Will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy which are likely to result in permanent loss of subsequent ovarian function or diminished fertility
* Have a medical condition or malignancy that requires removal of all or part of one or both ovaries
* Patients may have newly diagnosed or recurrent disease
* Be in good health so as to be able to undergo laparoscopic surgery as determined by history and physical examinations, and consultation with the medical oncologist, reproductive endocrinologist, surgeon and anesthesiologist

Exclusion Criteria:

* Moderate to high-risk of ovarian failure due to treatment
* Documented ovarian metastasis
* HIV or hepatitis (B, C)-positive serology
* Absolute surgical contraindications
* ECOG performance status of 0 or 1
* Pregnancy
* Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
Clinical Study of NK Cells in the Treatment of Severe Endometriosis

Dysfunction of natural koller cells (NK cells) is an important factor in the development of endometriosis. NK cell therapy was applied to treat severe endometriosis, which is an exploration of the pathogenesis of this refractory disease.

Endometriosis (EMs) is one of the common and frequently occurring diseases in women of childbearing age, which seriously affects the health and quality of life of the vast majority of women. The pathogenesis of endometriosis is unknown until now, and the recurrence rate of existing treatment methods is high. It is more and more necessary to introduce new therapeutic methods and strategies in view of the mechanism associated with the reduction of natural killer cell (NK) cytotoxicity. In this study, routine therapy combined with NK cell therapy was used in the treatment of severe endometriosis. The clinical data were collected to confirm the efficacy and safety of NK cell therapy. It is expected to provide a new way of thinking and method for the clinical treatment of EMs.

Eligibility Criteria:
Inclusion Criteria:

1. Diagonsed as endometriosis stage III\~IV
2. Age ≥18 years ≤ 45 years at the time of informed consent
3. With indications for conservative endometriosis surgery
4. With complete clinical data

Exclusion Criteria:

1. Severe allergy to drugs
2. Patients with abnormal immune status (Autoimmune disease or long-term use of immunosuppressive agents)
3. With serious cardiac, cerebrovascular diseases and liver, kidney disorders
4. With a history of severe mental illness
Safety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma

A single centre, open label, study to assess the safety, tolerability and biodegradation of PA5108 ocular implant in adults who have Open Angle Glaucoma (Primary or Secondary).

Participants who are currently managing their Open Angle Glaucoma with combination drop therapy will be recruited. Drop therapy will cease in the treatment eye and continue in the contralateral eye. The treated eye will receive via injection, a single PA5108 ocular implant. Participants will be monitored for safety and tolerability of the ocular implant until it completely biodegrades.

Eligibility Criteria:
Inclusion Criteria:

* Grade 3 or 4 open angle glaucoma (Shaffer-Etienne scale)
* Visual acuity in non-study eye same or better than study eye
* Currently taking topical ocular hypotensive medication including a prostaglandin analogue

Exclusion Criteria:

* Aphakic eyes
* Only one eye
* History of, or current uveitis, Cystoid Macular Edema (CME) or cornea edema
* Intraocular surgery or cornea/refractive surgery in study eye in past 6 months or anticipate need for eye surgery (including laser) in study eye during study period
* Current retinal detachment
* Uncontrolled infection in the eye
SNAP 25 Gene Study

To enhance our capacity to correctly choose the appropriate medication for ADHD patients on the first try based on the presence of a particular variant of a gene that could be identified on a laboratory test. It is hypothesized that patients with Attention Deficit Hyperactivity Disorder (ADHD) who have failed to respond to methylphenidate medication, but do respond to amphetamines, have a higher than expected incidence the allelic variants of the SNAP 25 gene associated with ADHD, and mutations of the dopamine system genes DRD1, 2, 4, 5 and dopamine transporter and COMTand MAOA.

Previous research has demonstrated that while 75% of patients respond to any stimulant, of those who do not 33% will respond to a stimulant of the other class. Based on previous research correlating increased mutations in the dopamine system genes DRD1, 2, 4, 5, dopamine transporter, COMT, and MAOA with ADHD, we will also be investigating the relationship between mutations in these genes and patient response to MPH and amphetamines. This study is a pilot, but it was an obvious next step in the studies that are being done on the genetics of ADHD. The outcome of this research, whether an association is or is not found, will be of considerable interest to researchers internationally, and will demonstrate the value of HELP funding in promoting research that can alleviate mental illness in children The study will make a significant contribution to appropriate intervention for these children, and promote greater awareness that the deficits suffered by children with attention problems is neither willful nor a matter of intelligence, but rather a syndrome that can be explained and can be modified with appropriate medical care.

A chi-square test will be conducted to determine whether there is differential representation of SNAP 25 among therapeutic methylphenidate responders versus non-responders. Statistical comparison will be performed using a two-tailed test at the .05 level of significance.

Eligibility Criteria:
Inclusion Criteria:

1. Patients will be male or female outpatients who are at least 6 years of age (there is no upper age limit)
2. Patients must meet DSM-IV criteria for ADHD
3. Patients and parents/guardians must have a degree of understanding sufficient to be able to communicate suitably with the investigator and study coordinator
4. Patients must have tolerated the drug at therapeutic doses, but have shown a true lack of improvement in symptoms
5. Must have shown clinically significant superiority in improvement in ADHD symptoms on amphetamine relative to MPH.

Exclusion Criteria:

1. Must not have a true allergy to methylphenidate or amphetamines
2. Must not have a history of serious adverse reactions to methylphenidate
Adherence-Suppression-Resistance Relationships for Atripla Compared to Historical Antiretroviral Regimens

The study is recruiting 50 patients initiating or switching to Atripla and comparing them to 250 individuals previously followed in a prospective study of HIV+ low income individuals recruited from homeless shelters, single room occupancy hotels and free meal food lines as part of the UCSF Reach Study. Adherence will be measured through monthly unannounced pill counts and electronic medication monitors.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years old;
* HIV+;
* Initiating Atripla within 6-months of recruitment;
* Lives in the Tenderloin, South of Market, or Mission District San Francisco;
* Capable of providing informed consent; and
* Willing to complete all study procedures.

Exclusion Criteria:

* Intoxication, cognitive dysfunction or psychosis will preclude potential subjects from informed consent.
Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.

This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug. It is a prospective, randomized clinical trial with two cohorts: Group A: standard of care (SOC) plus liposomal bupivacaine (n=30) and Group B: SOC (n=30). All subjects will undergo open single-level posterior decompression and instrumented fusion for degenerative spondylolisthesis. The surgery is not an experimental procedure. Prior to closing the surgical wound, liposomal bupivacaine will be administered to Group A. The administration of the drug is a study procedure, but note that this is an indicated use of the drug. Postoperatively, subjects will be assessed for pain and opioid consumption. The investigator's hypothesis for statistical analysis is that there will be a 30% decrease in pain medication requirement for the experimental group (Group A: Liposomal bupivacaine ) versus the control group (Group B: No Liposomal bupivacaine).

Eligibility Criteria:
Inclusion Criteria:

* Has a primary diagnosis of single-level lumbar stenosis, disc herniation, and/or spondylolisthesis excluding degenerative disc disease
* Receives open, one-level posterior spinal fusion

Exclusion Criteria:

* Is opioid-tolerant. Opioid tolerant patients are receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.
* Experienced intraoperative complications (i.e., a dural tear or durotomy). Intra- and post-operative data will be excluded from the analysis for these patients.
* Has severe liver disease. Bupivacaine is primarily metabolized in the liver via conjugation with glucuronic acid. Patients with liver disease, especially severe disease may be more susceptible to toxicity.
* Has severe renal disease. Bupivacaine and the metabolite are primarily excreted by the kidneys. Excretion can be significantly changed by urinary perfusion, the presence of renal disease, factors affecting urinary pH, and renal blood flow
* Is less than 18 years old.
* Is pregnant.
* Cannot read and speak English.
Outcomes for Manual Lymphatic Drainage

In this context, the purpose of our study is to investigate the effect of MLD(manual lymphatic drainage) technique applied in addition to the standard postoperative rehabilitation protocol on pain, kinesophobia and quality of life in early periods in patients undergoing primary TKA(total knee arthroplasty) surgery. Our hypothesis is that the addition of the MLD technique to the standard postoperative rehabilitation protocol will improve the early clinical outcomes of patients undergoing primary TKA. In the future perspective, we anticipate that the data obtained as a result of our study will make a significant contribution to the relevant literature on the early and mid-term ameliorative effects of MLD on postoperative pain, kinesiophobia and quality of life, which will be possibly applied in addition to standard postoperative rehabilitation protocols in patients undergoing primary TKA.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 40-85
* were diagnosed with stage IV gonarthrosis
* planned primary total knee arthroplasty (TKA)
* were evaluated before the operation
* whose informed consents

Exclusion Criteria:

* Patients with postoperative pulmonary thromboembolism or treatment-related complications in the past,
* patients with osteoarthritis secondary bone or joint infections,
* patients with morbid obesity,
* patients with presence of hematological disease and malignancy,
* major cardiac pathology,
* venous insufficiency,
* patients taking high-dose anticoagulants
* patients with communication problems
A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects

The purpose of the study is to find out whether an experimental autologous dendritic cell vaccine is safe, well tolerated, and whether it can strengthen the immune system's response to HIV.

This is a randomized trial to evaluate whether mRNA-transfected dendritic cell vaccination is safe and immunogenic in HIV-infected participants who are on antiretroviral therapy.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 positive
* CD4+ T Cell count \>200
* Undetectable HIV viral load for 6 months prior to screening
* On antiretroviral treatment for 12 months prior to screening

Exclusion Criteria:

* Hepatitis C positive
* Detectable HIV viral load within 6 months prior to study entry
* Females who are pregnant or nursing
ROSE in Sunset Park

The purpose of this study is to learn more about pregnant women's' experience with Reach Out, Stay Strong, Essentials for mothers of newborns (ROSE) and to evaluate the effectiveness of the ROSE program in preventing and reducing post-partum depressive symptoms, decreasing stress, and increasing social support among pregnant women.

This is a 2-phase study, including a feasibility phase (Pilot, Phase 1), and an outcomes evaluation phase (Phase 2). Phase 1 tests the acceptability and feasibility of a postpartum depression prevention intervention among pregnant women attending a prenatal clinic in Sunset Park, Brooklyn. NYU research staff will be trained to implement this intervention. Based on the feedback received from women and staff in phase 1, the intervention will be modified accordingly. Phase 2 will be an outcomes evaluation to test the effectiveness of the intervention to decrease maternal stress and depressive symptoms, and increase perceived social support and self-efficacy among new mothers.

Eligibility Criteria:
Inclusion Criteria:

* Receive prenatal care at the Sunset Park Family Health Center for Women's Health and Pediatrics (SPWHP)
* Female
* At least 18 years of age
* Speaks and understands English or Spanish (depending on the language of the next group)
* Is pregnant
* Is in the second trimester of her pregnancy
* Capable of providing informed consent.
* Scores between 4 and 12 on Edinburgh Postnatal Depression Scale or records 2 or more ACEs on adapted ACEs questionnaire

Exclusion Criteria:

* Not receiving prenatal care at the Sunset Park Family Health Center for Women's Health and Pediatrics (SPWHP)
* Not female
* Under18 years of age
* Does not speak and understand English or Spanish
* Is not pregnant
* Is not in the second trimester of her pregnancy
* Is not capable of providing informed consent.
* Scoring \< 4or \>12 on Edinburgh Postnatal Depression Scale and scores 1 or less on adapted ACEs questionnaire.
* Positive score to #10 on the Edinburgh Postnatal Depression Scale
Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies

The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy on the development of these children over 7 years of clinical follow-up.

Although the effects of inhaled Nitric Oxide on pulmonary vascular tone are well-described and relevant to term infants with persistent pulmonary hypertension, the pathophysiology of respiratory failure in preterm infants may be quite different. Chronic lung disease (CLD) represents the final pathway of a heterogeneous group of pulmonary disorders of infancy that usually start in the neonatal period. CLD most commonly occurs in preterm (\<30 weeks of gestational age (GA) infants with birth weights less than 1,500 grams (g), and especially in those very preterm (\<26 weeks GA) with birth weights less than 1,000 g, and who have been treated for respiratory distress syndrome (RDS).

Eligibility Criteria:
Inclusion Criteria:

* Inborn preterm infants 24+0 weeks-28+6 days weeks gestational age (defined by first trimester ultrasound or if not available based on the last menstrual period) who requires the use of surfactant within 24 hours of birth (either prophylactically, or for signs of developing respiratory distress), or who requires the use of continuous positive airway pressure (CPAP) (fraction of inspired oxygen concentration (FiO2) ≥ 0.30 on a mean airway pressure ≥ 4cm water (H2O)) within 24 hours of birth in order to maintain an oxygen saturation (SpO2) ≥ 85%.
* Informed consent of the guardian.

Exclusion Criteria:

* Outborn infants.
* Infants ≥ 29 weeks gestational age.
* Infants requiring FiO2 \>0.5 to maintain SpO2 \>85%, on a sufficient mean airway pressure (e.g., \> 8 cm H2O on controlled mechanical ventilation (CMV)) in order to achieve adequate chest inflation (8-9 ribs on Chest X-ray) two hours after the proper administration of exogenous surfactant.
* Any suspected congenital heart disease other than patent ductus arteriosus or atrial septal defect.
* Any infant with severe bleeding or coagulation abnormalities at high-risk of diathesis, e.g., platelet \<50,000 per millimeter cube (mm³), fibrinogen \<0.5 gram per liter (g/L), other clotting factors \<10%.
* Any infant in whom a decision has been made not to provide full treatment, e.g., chromosomal abnormalities, severe multiple abnormalities, severe birth asphyxia, etc.
* Use of another investigational drug or device before or during the active study period.
Safety and Efficacy of Fetoscopes Used in Fetoscopic Selective Laser Photocoagulation

The purpose of this study is to evaluate the safety and efficacy of the investigational fetoscopes used in patients undergoing fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic pregnancies.

All patients who choose to undergo fetoscopic selective laser photocoagulation (S-PLC) at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and patients provided a copy of the signed consent.

Fetoscopic Procedure: Selective laser photocoagulation (S-PLC) is standard of care for the treatment of complicated monochorionic twin pregnancies and will be performed with the same technique in this study as it is with the use of the currently approved fetoscopes. In the majority of cases, in utero access has been achieved using a small percutaneous incision under ultrasound guidance with the instruments inserted through the maternal abdomen, uterine wall and into the recipient fetus' gestational sac. The fetoscope is then used to "map" the placental vascular pattern. Communicating vessels between the fetuses are ablated using laser energy via a 400-600 micron laser fiber that has been introduced through the instrument channel of the operating sheath. Intravenous sedation with local anesthesia at the site of insertion has been found to provide sufficient maternal anesthesia for the procedure. At the completion of the S-PLC, the excess amniotic fluid in the recipient twin's sac is removed to achieve a normal volume.

Follow-Up: The investigators will follow patients for the immediate post-procedure period (until they leave the OR).

Eligibility Criteria:
Inclusion Criteria:

* Patients who are eligible and elect to undergo fetoscopic selective laser photocoagulation for the treatment of complicated monochorionic-diamniotic pregnancies.

Exclusion Criteria:

* Patients who do not elect to undergo fetoscopic laser photocoagulation for treatment of complicated monochorionic-diamniotic pregnancies.
A Longitudinal Prospective Outcomes Study of Laparoscopic Abdominal Wall Hernia Repair Using Symbotex™ Composite Mesh

This study is being done to test the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias.

This study is being done to validate the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias. It will also set the groundwork for a future clinical trial in which the efficacy of Symbotex® can be compared to other synthetic mesh products on the market.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Grade I or II ventral hernia according to VHWG classification system
* Pre-operative informed consent is obtainable

Exclusion Criteria:

* Not candidate for laparoscopic approach for repair of their hernia
* Determination in the operating room that biologic mesh is needed over permanent mesh
* Fascial defect less than 3 cm in greatest dimension
* Concurrent placement of another mesh (synthetic or biologic ) at the site where the study mesh is placed
* Grade III or IV ventral hernia according to VHWG system
* ASA score IV or above
* Any disease or condition along with the surgeon's clinical judgment that contraindicates the use of study mesh. These include but are not limited to the presence of chronically infected tissues subjecting patient to risk of synthetic mesh infection, accidental bowel injury during surgery or anatomy of the patient that is not receptive to laparoscopic surgery or mesh implantation.
* Pregnancy
* Use of more than one of the same study mesh is not an exclusion criterion in and of itself, so long as the type of mesh is selected according to the randomization protocol. In other words, if the hernia defect is larger than the largest Symbotex™ mesh available, two or more Symbotex mesh pieces may be used to appropriately repair the hernia defect.