cyrilzakka/clinical-trials huggingface dataset:
The Changes of Natural Killer Cells Frequency and Function During Antiviral Therapy

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, NKs are the main effector cells in early antiviral innate immune response. This study was aimed at investigating the changes of NKs frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, investigators want to verify whether Peg IFN - alpha suppressed the virus and the reduction of virus led to the recovery of NKs function, or Peg IFN - alpha enhanced NKs function which gave rise to the decline of the virus.

Pegylated interferon α-2a(Peg-IFN-α)and Nucleoside analog(ue) drugs can inhibit viral replication , but Peg-IFN-α also play an important role in immune regulation . In hepatitis B infection, NKs are the main effector cells in early antiviral innate immune response.Peg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than nucleoside analog(ue) drugs, which may be related to the functional activation of pDCs in the case of hepatitis and the function enhancement of NKs during Peg-IFN-α therapy. This study was aimed at investigating the changes of NKs frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, investigators want to explore whether the decline of HBsAg and HBeAg resulted in recovery of NKs function, or recovery of NKs function led to the decrease of HBsAg and HBeAg. Several studies demonstrated that HBsAg and HBeAg could damage NKs function, and the loss of HBsAg and HBeAg led to recovery of NKs function.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg and HBeAg positive for more than 6 months, HBV DNA detectable with ALT level abnormal lasted for three months and at least time190 IU/L or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled.

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
Round Spermatid Injection Protocol

To evaluate embryology outcomes after application of a technique known as round spermatid injection (ROSI) into donor oocytes in a high-volume clinical infertility practice.

The objective of this study is to assess embryology outcomes after implementation of a laboratory protocol known as ROSI at a high-volume clinical infertility practice. All samples from enrolled male patients with azoospermia who proceed with surgical sperm extraction (TESE or microTESE) will be evaluated for the presence of round spermatids. These round spermatids will be used as research samples as opposed to being discarded.

The investigators aim to identify whether the injection of round spermatids into donor oocytes can lead to successful fertilization, progression to the blastocyst stage, and euploid status. Performance of ROSI using donor oocytes not intended for implantation will allow the investigators to gain valuable insight regarding fertilization and development without any direct risk to patients or future offspring. These embryos are being generated for research purposes only and will ultimately be destroyed after the study has concluded. The investigators will measure rates of isolation of round spermatids from surgical samples, fertilization rates using donor oocytes, rates of progression to the blastocyst stage, and rates of aneuploidy using the previously described technique of ROSI.

Eligibility Criteria:
Major Inclusion Criteria: The following are major inclusion criteria:

1. A diagnosis of azoospermia after semen analysis.
2. Indication to proceed with testicular sperm extraction (TESE or microTESE) based on a urologic evaluation.
3. Presence of round spermatids from testicular sperm extraction (TESE or microTESE), irrespective of the presence or absence of mature spermatozoa.

Major Exclusion Criteria (must not meet any): The following are exclusion criteria:

1. Under 18 years old
2. All patients who do not voluntarily give their written consent for participation.
3. Men who do not wish to use their gametes (round spermatids) for fertilization of donor oocytes for research purposes.
NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™

The purpose of this study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Eligibility Criteria:
Inclusion Criteria:

* Subject presents with lung lesion(s) requiring evaluation
* Subject is willing and able to provide informed consent to participate in the study
* Subject is candidate for elective ENB™ procedure
* Subject is over the age of 18

Exclusion Criteria:

* The subject is unable or unwilling to comply with study follow-up schedule
* The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
* Female subjects who are pregnant or nursing as determined by standard site practices
A Study of Moderate-to-severe Plaque Psoriasis Patients Response to Secukinumab Treatment in Real-world Setting

This study was a one-arm, retrospective cohort study that observed clinical psoriasis patients who received secukinumab treatment in Indonesia from the 01 August 2017 until the 31 October 2020. Patients' data were obtained from the medical records of a dermatology clinic in Jakarta, Indonesia. The primary endpoints were set at Week 16, and secondary endpoints at Weeks 16 and 52. At each endpoint, the study assessed effectiveness by measuring the proportion of psoriasis patients receiving secukinumab who achieved Psoriasis Area and Severity Index (PASI) 75 (at Week 8) and PASI 90 (at Weeks 16 and 52).


Eligibility Criteria:
Inclusion Criteria

* Male or female, aged at least 18 years old.
* Diagnosed as moderate-to-severe plaque type psoriasis with PASI score ≥ 5 prior to initiating secukinumab treatment.
* Treated with secukinumab for a minimum of 8 weeks after the initial secukinumab treatment without any interruption.
* Patients included in this study received the initial secukinumab treatment within the period of 1 August 2017 to 31 October 2019. With the secondary endpoint of 52 weeks, the latest recorded data included in the analysis was recorded on 31 October 2020.

Exclusion Criteria

* Patients with other types of psoriasis.
* Patients with incomplete information on PASI score at Weeks 0, 8, and 16 in their medical records.
Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates

The purpose of this study was to evaluate the performance of three Bayer Blood Glucose Monitoring Systems (BGMS) with neonatal blood. Blood samples used in this study were 'left-over samples'. The blood samples were from heel sticks of neonates, collected (into a tube) and sent to the laboratory. All meter Blood Glucose (BG) results were compared with capillary plasma results obtained with a reference laboratory glucose method (Cobas® 6000 instrument).


Eligibility Criteria:
Inclusion Criteria:

* Routine blood samples (heelstick) collected from neonates (less than 30 days of age).
* A portion of the samples (approximately 10%) will be from subjects \<24 hours old.
* A portion of the samples (at least 10%) will be from subjects in the NICU.
* Sample blood volume must be sufficient to complete investigational testing in addition to prescribed testing.

Exclusion Criteria:

* Samples from babies \>=30 days of age
Nasal Resonance Change After Endoscopic Endonasal Transsphenoidal Skull Base Surgery: Analysis of Quality of Voice

The purpose of this study is to determine nasal resonance change after endoscopic endonasal transsphenoidal skull base surgery. Furthermore, the quality of voice is assessed, also.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent endoscopic endonasal transsphenoidal skull base surgery

Exclusion Criteria:

* Patients under 18 year
* Patients cannot following command including loss of conscious
* Patients cannot speak including patient on tracheostomy tube
* Patients who has nasal tumor, nasal polyp, sinusitis
* Patients who has cleft lip cleft palate or submucosal cleft
* Patients who underwent adenotonsillectomy or palatoplasty in same setting with endoscopic pituitary surgery
Validation of Brain Function Assessment Algorithm for mTBI/Concussion

This study is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of validation of the algorithms.

EEG, neurocognitive performance and clinical data will be collected at time of injury (within 3 days) at clinically determined Return to Play (RTP) and 45 days after RTP, for the purpose of independently validating the performance of the algorithms developed in prior studies (NCT02477943, NCT02661633 and NCTXXXXXX). Data collected under this study will be combined with that collected under NCT02957461 for the final analyses of prospective algorithm performance in an independent population ages 13-25 years. Subjects will come from the sports and other populations of concussed individuals. They will be matched with controls i.e. not head injured subjects who will also undergo the same set of tests and the same time intervals as the injured subjects. An additional pool of uninjured (not head injured) subjects will be collected who will be assessed at a single time point.

Eligibility Criteria:
Inclusion Criteria:

For Injured subjects:

1. Having sustained a traumatic closed head injury within 72 hours (3 days) from time of injury at time of BrainScope assessment;
2. GCS 13-15 at time of BrainScope assessment;
3. No hospital admission due to either head injury or collateral injuries for \>24 hours.

For Matched Controls:

1. GCS 15 at time of BrainScope assessment;
2. No prior history of concussion or TBI in the last year.

Exclusion Criteria:

1. Previously enrolled in the BrainScope CAS Studies;
2. Current CNS active prescription medications taken daily, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD);
3. Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection;
4. History of brain surgery or neurological disease;
5. Pregnant women;
6. Subjects who do not speak English (non-English speaking parents are allowed to consent so long as translation of the consent form in their native language is available);
7. Acute intoxication;
8. Evidence of illicit drug usage;

For Injured subjects:

1. Loss of consciousness ≥ 20 minutes related to the concussion injury;
2. Active fever defined as greater than 100ºF or 37.78ºC at time of BrainScope assessment;
3. Evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment).

For Matched Controls:

1. Any focal neurological signs including aphasia, apraxia, diplopia, facial droop, dysarthria/slurred speech;
2. History of Motor Vehicle Accident (MVA) requiring an Emergency Department visit within the past 1 year.
SMART Use of Medication for the Treatment of Adolescent Severe Obesity

This study will examine the timing and sequence of using adjunct obesity pharmacotherapy for adolescents with severe obesity who do not respond to lifestyle modification therapy alone.

This project is studying the best time to add weight loss medication to diet and exercise for helping adolescents who carry extra weight. All participants start with a lifestyle modification program and some participants may also receive study medication.Participants must be 12-17 years of age and carry extra weight. The program will last for 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed assent form;
* Provision of signed and dated informed parental consent form from at least 1 legal parent/guardian;
* Stated willingness to comply with all study procedures and availability for the duration of the study;
* BMI \>/= 1.2 times the 95th percentile or BMI \>/= 35 Kg/m2, whichever is lower;
* Tanner stage \>/= 2;
* Male or female, aged 12-17 at time of consenting;
* For females of reproductive potential: when sexually active, agreement to use highly effective contraception (oral contraceptive pill, intra-uterine device (IUD), or implant) during study participation;
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

Exclusion Criteria:

* Contraindications to phentermine or topiramate use according to package inserts, including: history of glaucoma; current or recent (\< 14 days) use of monoamine oxidase inhibitor; known hypersensitivity to sympathomimetic amines; current pregnancy, plans to become pregnant, or if sexually active refusal to use 2 forms of birth control; history of cardiac disease including coronary artery disease; clinically significant cardiac arrhythmias; heart failure or uncontrolled hypertension;
* Diabetes (type 1 or 2);
* Presence of cardiac pacemaker;
* Current or recent (\<6 months prior to enrollment) use of weight loss medication(s);
* Current use of weight-altering medication(s) (e.g., atypical antipsychotic, metformin) unless dose has been stable for past 6 months;
* Current use of other sympathomimetic amine such as attention-deficit hyperactivity disorder (ADHD) stimulants;
* Seizure disorder (other than infantile febrile seizure);
* Previous bariatric surgery;
* Recent initiation of change in dose (\< 3 months prior to enrollment) of anti-hypertensive or lipid medication(s);
* Tobacco use
* History of or current diagnosis of schizophrenia, psychosis, mania, chemical dependency;
* Unstable depression or anxiety that has required hospitalization in the past year;
* Any history of suicide attempt;
* Suicidal ideation or self-harm within 12 months prior to enrollment;
* Bicarbonate \< 18 mmol/L;
* Creatinine \> 1.2 mg/dL;
* History of cholelithiasis;
* History of nephrolithiasis;
* Untreated thyroid disorder;
* Hyperthyroidism;
* Breastfeeding
Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)

The purpose of this study is to determine the safety and efficacy of an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 6636) as a single agent in Adult Patients With Squamous Cell Carcinoma of the Head \& Neck and will help determine if further development is justified.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven squamous cell carcinoma of the head \& neck.
* Age greater than or equal to 18.
* ECOG performance status of 0 to 1
* Measurable malignant disease.
* Patients that have failed at least one platinum-containing regimen and have received no more than three prior regimens and do not have other curative treatment options.
* Patients must be at least 2 wks post surgery or radiation therapy
* Patients must be at least 4 weeks post chemotherapy
* Meets protocol requirements for specified laboratory values.
* Written informed consent and cooperation of patient.
* Appropriate use of effective contraception if of childbearing potential.
* No investigational drugs of any type within 30 days prior to administration.

Exclusion Criteria:

* Prior exposure to farnesyl transferase inhibitors
* Medical conditions that would interfere with taking oral medications.
* Patients with significant QTc prolongation at baseline (\>500 msec.)
* Pregnant or nursing women
* Known HIV positivity or AIDS-related illness.
* Concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy
* Patients with any signs of involvement of the dura, meninges, or brain.
* Patients with squamous cell carcinoma of the nasopharynx
* Patients who currently have other cancers or have been treated in the last 5 years for any other malignancy.
Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)

This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Biohelix (BHX) Implant system.

This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto BHX Implant system. The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines
* Adequate bone quality to allow for a Ponto BHX implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected

Exclusion Criteria:

* Patients undergoing re-implantation
* Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.
* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus
* Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator
* Any other known condition that the investigator determines could interfere with compliance or study assessments
Modified Functional Magnetic Stimulation Treatment for Constipation Improvement

To prove the modify functional magnetic stimulation could improve constipation.

1. Permission： Any agent without effecting gastrointestinal motility or defecation is allowed.
2. Inhibition： From test day to the next day(48 hours),it's not allowed to take any medication treatment which might affect digestive system or excretory system.

Eligibility Criteria:
Inclusion Criteria:

* Patients who age between 20\~60 years old and have suffered from chronic constipation for more than 6 months will be enrolled in this study.

Exclusion Criteria:

* Patients with implantation chip of brain
* Patients with implantation of pacemaker
* Patients with heart transplantation
* Patients are embedded electronic and Life support products.
* People who have be implanted metal、electronic devices、artificial joints or fixator.
* Patients with hemiplegia
* Patients with peripheral neuritis
* Patients with Prostate abnormalities
* Patients with Pregnancy
* Patients with Fever
* Patients with Injure
* Patients with Heart disease
* Patients with Consciousness disturbance
* Patients with Organic constipation
* Patients with Kidney stone
* Patients with Ureteric calculus
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.

This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-65 years of age;
* HBeAg negative chronic hepatitis B;
* treated with lamivudine for \>=6 months;
* demonstrated lamivudine resistance;
* compensated liver disease.

Exclusion Criteria:

* severe hepatic dysfunction;
* previous treatment with antivirals other than lamivudine;
* immunosuppressant treatment in past 6 months;
* co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
* medical condition associated with chronic liver disease.
The Study to Treat Superficial Femoral Artery Occlusions.

The main objective of this study is to assess the performance of the Cordis SMART™ nitinol self-expandable stent for the treatment of superficial femoral artery (SFA) occlusions in comparison with balloon angioplasty only as determined by binary restenosis at one year.

This is a multi-center, prospective, randomized, two-arm study evaluating the performance of the Cordis SMART™ nitinol self-expanding stent as compared to angioplasty only.

It is anticipated that a total of 150 patients will be entered into the study. Patients will be randomized on a 1:1 basis of stent versus angioplasty only.

150 patients with de novo or restenotic native SFA occlusions (5-22 cm) with reference vessel of \>= 4.0 to \<= 6.0 mm in diameter will be randomized to the SMART™ nitinol self-expanding stent or to angioplasty only.

All patients will be followed for 12 months post-procedure, by telephone contact at 3 and 6 months, and a 12 month clinical and duplex ultrasound assessment. This study will be conducted at up to 12 investigational sites.

Eligibility Criteria:
Inclusion Criteria:

* One superficial femoral artery de novo or restenotic lesion (\> 70% stenosis or occlusions), with a lesion length \> 5 to \< 22 cm.
* Patent popliteal artery on the index side, i.e., single vessel runoff or better with at least one of three vessels patent to the lower 1/3 of the calf prior to the day of the procedure. Additional intervention to further improve blood flow to the lower limb is acceptable during the index procedure, but after successful treatment of the study lesions

Exclusion Criteria:

* Revascularisation involving the same limb within 7 days prior to the index procedure or a planned revascularisation within 7 days after the index procedure Patient having total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow is allowed during the same procedure and prior to the treatment of the study lesion.
* Patients enrolled in this or other clinical trial or anticipated to be included into a trial, without written approval of the Cordis medical monitor and the principal investigator of this study.