cyrilzakka/clinical-trials huggingface dataset:
Molecular Profiling in Small Cell Lung Cancer

This protocol is to obtain tumor tissues and blood samples from patients with a confirmed histological diagnosis of Small cell lung cancer(SCLC) for molecular profiling.

Small cell lung cancer (SCLC) is most invasive subtypes of lung cancer. After diagnosis, the SCLC patients without treatment often die in 2-4 months. SCLC is a highly heterogeneous malignant tumor, the previous treatment principle of the tumor is based on the traditional histopathology, which not provide accurate guidance for precise treatment. In recent years, breakthrough has been made in molecular classification of breast cancer, non-small cell lung cancer, gastrointestinal cancer and of the other tumor, but SCLC molecular classification has not yet reported.

In this prospective study, SCLC tissues and blood samples from extensive SCLC patients will be obtained and evaluated of molecular profiling. Eligible population includes: patients who have not undergone any treatment and diagnosed of extensive SCLC by immunohistochemistry(IHC). The purpose is to evaluate molecular profiling of SCLC patients who are sensitive or resistant to chemotherapy (Cisplatin+Etoposide). To compare molecular alterations of SCLC patients with different prognosis (Overall Survival, Progress Free Survival).

Eligibility Criteria:
Inclusion Criteria:

* Age: between 18 and 75 years old.
* Sexes Eligible for Study: All
* Diagnosed of SCLC by IHC, and divided into extensive stage.
* The ECOG (Eastern Cooperative Oncology Group, ECOG) PS(performance status，PS) Scale score is 0 or 1.
* At least one measurable lesions by CT scan.
* Expect to survive for at least three months.
* Peripheral blood routine and liver and kidney function meet the following criterion (blood draw 7 days before the treatment begins) :
* The White Blood Cell (WBC) is greater than the 3.0×10\^9/L or neutrophils (ANC) more than 1.5 x10\^9/L;
* Hemoglobin (HGB) is greater than 80 g/L.
* Platelet (PLT) is greater than 100×10\^9/L.
* (AST/ALT): Aspartate aminotransferase/Alanine aminotransferase\<3.0 times of normal range.
* Total bilirubin (TBIL) \< 1.5 times of normal range.
* Creatinine (CREAT) \< 1.5 times of normal range.
* Female or male patients must adopt effective birth control measures.
* Informed consent forms provided. Patients must meet each of the above criteria.

Exclusion Criteria:

* Other pathological types of tumors ,rather than small cell lung cancer.
* Incorporating other tumors in the early diagnosis;
* Patients who have received chemotherapy, radiotherapy or any other anti-cancer treatment.
* Patients that known to be allergic to the drug components involved in the study;
* Patients with severe allergies or allergies;
* Pregnant or breastfeeding women;
* Patients with acute infection which is difficult to control;
* Drug abuse, substance abuse, long-term alcohol and AIDS(Acquired Immune Deficiency Syndrome) patients.

Candidates who meet each of the exclusion criteria will not included in the research.
Fiber Blends and Gut Microbiota (FB)

The purpose of this research study is to determine whether consuming snacks containing different blends of dietary fibers alters the type and number of bacteria found in your gut and improves markers of overall health.

All subjects will complete a 47-day, multi-phase feeding study to evaluate the effect of two snack prototypes containing two different fiber blends on gut community structure and features of host biological state (plasma proteome/ metabolome). The information gained from this work will increase our understanding of the importance of specific dietary fibers in manipulating the composition of the gut microbiota in ways that may improve our metabolic health.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥25.0 and ≤35.0 kg/m2
* ≥18 and ≤60 years

Exclusion Criteria:

* previous bariatric surgery
* significant organ system dysfunction (e.g., diabetes, severe pulmonary, kidney, liver or cardiovascular disease)
* cancer or cancer that has been in remission for \<5 years
* major psychiatric illness
* inflammatory gastrointestinal disease
* pregnant or lactating women
* use of medications that are known to affect the study outcome measures and that cannot be temporarily discontinued for this study
* use of medications known to affect the composition of the gut microbiota within the last 30 days (most notably antibiotics)
* bowel movements \<3 times per week
* vegans, vegetarians, those with lactose intolerance and/or severe allergies/aversions/sensitivities to foods and ingredients included in the prescribed meal plan
* persons who are not able to grant voluntary informed consent
* persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits.
A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study

The purpose of this study is to provide a single clinical study with a uniform approach to monitoring long-term safety and efficacy in participants who received delandistrogene moxeparvovec in a previous clinical study. No study drug will be administered as part of this study. Pre-infusion baseline will be defined as the timepoint just prior to infusion of delandistrogene moxeparvovec from a previous clinical study. Each participant will be followed for a minimum of 5 years post-infusion of delandistrogene moxeparvovec from a previous clinical study. The duration of participation in this study is dependent on the length of follow-up the participant completed post-infusion of delandistrogene moxeparvovec from a previous clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Received delandistrogene moxeparvovec for Duchenne muscular dystrophy in a previous clinical study.
* Has (a) parent(s) or legal caregiver(s) or is ≥18 years of age and able to understand and comply with the study visit schedule and all other protocol requirements.

Exclusion Criteria:

* Participant or family does not want to disclose participation with general practitioner/primary care physician and other medical providers.

Other inclusion/exclusion criteria may apply.
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years

This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 given as single dose to healthy adults 56 years or older compared to the meningococcal polysaccharide vaccine MencevaxACWYTM.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol
* A male or female 56 years of age or older at the time of the vaccination.
* Written informed consent obtained from the subject.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Non-child-bearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product.
* Extended administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. Inhaled and topical steroids are allowed.
* Any contra-indication to intramuscular and /or subcutaneous injection.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination and ending 30 days after vaccination. (Vaccination with inactivated influenza vaccines, including H1N1, is allowed at any time during the study as per local recommendations).
* Previous vaccination with meningococcal serogroups A, C, W-135 and Y polysaccharide vaccine within 5 years prior to vaccination.
* Previous vaccination at any time with meningococcal serogroups A, C, W-135 and Y polysaccharide conjugate vaccine.
* Previous vaccination with tetanus toxoid containing vaccine within 5 years prior to vaccination.
* History of meningococcal disease due to serogroups A, C, W-135 or Y.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* History of neurological disorders and seizures
* History of Guillain-Barre syndrome.
* Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests.
* Acute disease and/or fever at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine/product or planned administration during the study period.
* Pregnant or lactating female.
* Current chronic alcohol consumption and/or drug abuse.
Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer.

This study investigates the safety and efficacy of the combination therapy with BAY86-9766 and sorafenib in patients with liver cancer. Safety will be determined by laboratory and other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined by disease control rate, overall survival, time to progression, response rate and duration of response.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female age \>/= 18 years of age
* Life expectancy \>/= 12 weeks
* Histologically or cytologically confirmed diagnosis of HCC, unresectable advanced or metastatic
* Liver function status of Child-Pugh class A. Child-Pugh status based on clinical findings and laboratory results during the screening period
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
* Patients must have at least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Previous or concurrent cancer other than HCC, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors.
* History of cardiac disease: Congestive heart failure (CHF), unstable angina, arrhythmias, Uncontrolled hypertension
* Clinically significant GI bleeding (CTCAE grade 3 or higher) within 30 days
* Renal failure requiring hemo- or peritoneal dialysis
* Known human immunodeficiency virus (HIV) infection
* Known history or symptomatic metastatic brain or meningeal tumors
* History of organ allograft.
* History of interstitial lung disease (ILD).
* Excluded previous therapies and medications:

  * Prior use of systemic anti-cancer treatment for HCC including cytotoxic chemotherapy, targeted agents, or any experimental therapy
  * Radiotherapy within 4 weeks prior to start of study treatment
  * Any other investigational agents within 4 weeks from the first dose of study treatment
  * Major surgery within 4 weeks of start of study
  * Concomitant use of strong inhibitors and strong inducers of CYP3A4
Assessment of an Automated Optical Coherence Tomography and Camera : Reference Database

The objective of this study is to establish the Reference database of Vision-700.

The objective is to collect and establish the Reference database of Vision-700, which is expected to recruit subjects with normal vision to collect the optical coherent tomography measurement data.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects 22 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects presenting at the site with normal eyes bilaterally
4. IOP ≤ 21 mmHg bilaterally
5. BCVA 20/40 or better bilaterally

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging.
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images.
3. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses \> 20% or false positives \> 33%, or false negatives \> 33%
4. Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings: On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; Glaucoma hemi-field test "outside normal limits."
5. History of leukemia, dementia or multiple sclerosis.
6. History of hydroxychloroquine or chloroquine use.
7. Subjects with photosensitivity.
8. Subject having Photodynamic therapy (PDT) within 6 months.
9. Subjects taking photosensitivity drug currently.
A Study of Rovalpituzumab Tesirine to Study Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer

Study to evaluate the effect of rovalpituzumab tesirine on cardiac ventricular repolarization in subjects with small cell lung cancer (SCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed extensive-stage small-cell lung cancer (SCLC).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Adequate hematologic and organ function as confirmed by laboratory values

Exclusion Criteria:

* Clinically significant cardiac abnormalities including QRS duration of \>120 msec; QTcF \>470 msec for women and \>450 msec for men; Abnormal cardiac rhythm; Clinically significant cardiac valve abnormality; Documented history of left ventricular ejection fraction \<0.30 within 6 months; Permanent pacemaker or automatic implantable cardioverter defibrillator; History of torsades de pointes, congenital long QT syndrome, or family history of long QT syndrome or sudden death
* Recent or ongoing serious infection
* Women who are pregnant or breastfeeding
* Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation.
Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients

Comparative study between surgical and non surgical treatment of anismus in patients with symptoms of obstructed defecation.

Anismus is a significant cause of chronic constipation. This study came to compare the results of BFB training , BTX-A injection and PDPR in the treatment of anismus patients. Patients and methods: Seventy two anismus patients fulfilled Rome II criteria for functional constipation were included in this study. All patients underwent anorectal manometry, balloon expulsion test, defecography, and electromyography activity of the EAS. All patients had non relaxing puborectalis muscle.. The patients were randomized into three groups. Group I patients received biofeedback therapy, two times per week for about 1 month. Group II patients were injected with BTX- A. Group 111 partial division of puborectalis was done. Follow up was conducted weekly in the first month then monthly for about 1 year.

Key words:

Obstructed defecation, chronic constipation, puborectalis, pelvic floor

Eligibility Criteria:
Inclusion Criteria:

* 60patients fulfilled Rome II criteria for functional constipation
* All patients were unresponsive to laxatives or enema use

Exclusion Criteria:

* Pregnant patients
* Patients with sphincteric defect
* Any patient proved to have colonic inertia by colon transit time
* Any patient with previous history of pelvic surgery e.g. mesh rectopexy
* Duhamel operation were excluded
Exploration of Gait Biomechanics and Pain

This interventional study aims to test gait biomechanics in healthy individuals with and without experimental knee pain. The main questions it aims to answer are:

* How do gait patterns change during painful walking?
* Can pain sensitivity testing and gait biomechanics predict experimental knee pain intensity?

Participants will receive two knee injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition).

This study will be a randomized, crossover design where experimental knee pain will be provoked in healthy subjects using hypertonic saline injections to the infrapatellar fat pad (IFP). This will be controlled with a second injection of isotonic saline, which is non-painful. The participants will not be informed of the type of injection.

Hypertonic saline injections to the IFP usually provoke pain lasting about 15 minutes. Within this timeframe, motion capture will be conducted to estimate the biomechanics of gait. During the motion capture the participants will perform five 10-meter walking trials and three jumps. This process will be replicated for the control condition.

Additionally, the participants will have their pain sensitivity tested using cuff-pressure algometry before both IFP injections.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged 18-45 years

Exclusion Criteria:

* Pregnancy
* Drug addiction, defined as the use of cannabis, opioids, or other drugs
* Previous or current neurologic or musculoskeletal illnesses
* Current pain
* Lack of ability to cooperate
Surgical Correction of Pelvic Organ Prolapse

Objective:

This prospective randomized trial evaluated outcomes of colposacropexy performed either by open or by conventional laparoscopic approach as therapy for uterovaginal prolapse. Surgical techniques, efficacy and overall results are compared.

Methods:

In this prospective study 40 consecutive patients with uro-genital prolapse are randomized to sacropexy: 20 by an open approach, 20 by a conventional laparoscopy approach. Anchorage is achieved in both groups by two polypropylene meshes.

Check-ups were scheduled at 3, 6, 12 months and then yearly. Pre-operative patient characteristics, operative and post-operative events and follow-up results are recorded.

Surgical technique In both open or laparoscopic approach the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area of at least 3 x 5 cms where the mesh will be attached with four-five Polyglycolic 0 sutures. The procedure is repeated for the posterior vaginal wall, where the mesh will be attached with three-four Polyglycolic 0 sutures.

The sacral promontory surface is prepared and 1 or 2 non-reabsorbable 0.0 sutures are placed into the sacral periosteum about 2 cm below the promontory. A sub-peritoneal tunnel is created through which meshes are passed avoiding traction to the sacrum. The peritoneum is closed over the meshes.

Eligibility Criteria:
Inclusion Criteria:

* Study inclusion criteria were POP \> 2, age ≥ 18 and ≤ 75 yrs.

Exclusion Criteria:

* Malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma)

  * Active pelvic inflammatory disease,
  * Known hypersensitivity to synthetic materials (polypropylene or polyglycolic acid)
  * Pregnancy or lactation
  * Evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases; and
  * Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
The Combination of GnRh Analogue and Aromatase Inhibitor in Receptor Positive Premenopausal Women With Advanced Breast Cancer

The Combination of GnRh Analogue and Aromatase Inhibitor in Receptor Positive Premenopausal Women with Advanced Breast Cancer A Prospective Trial.

The Combination of GnRh Analogue and Aromatase Inhibitor in Receptor Positive Premenopausal Women with Advanced Breast Cancer A Prospective Trial.

Eligibility Criteria:
Inclusion Criteria:

* Receptor Positive Premenopausal Women with Advanced Breast Cancer.

Exclusion Criteria:

* Any woman other than diagnosis of Receptor Positive Premenopausal with Advanced Breast Cancer.
Balance in Children With Cochlear Implants

The purpose is to test the balance of children with unilateral,bilateral cochlear implants and patients having unilateral implants before,bilateral implants after surgery,using the Bruininks-Oseretsky Test 2nd ed. to find out if the cochlear implants have an effect.

Hearing impairment has a significant impact on individual quality of life and stresses community resources. In the last two decades cochlear implantation has developed into the new standard of care for severe to profound haring loss. Recent studies have shown bilateral implantation improves sound localization and understanding of speech in noise. For children, this is seen as a significant benefit. As we begin to offer bilateral cochlear implants to a growing number of children it would be in our patient's best interest to evaluate whether or not this may cause balance impairment. We will evaluate the balance scores of children with bilateral cochlear implants, and compare their results to unilaterally implanted children and a hearing impaired population, with the Bruininks-Oseretsky Test 2nd ed (BOT2). In addition we will take a small group of unilaterally implanted patients and test them before and after a contralateral cochlear implant as a prospective study group.

Eligibility Criteria:
Inclusion Criteria:

* Children with cochlear implant(s) activated for at least two weeks before participation.
* Children with severe to profound deafness that have not received intervention.

Exclusion Criteria:

* Children with mental retardation, associated physical handicaps, or chronic sedative use prohibiting completion of the balance tests.
PeriOperative Bridging - Perioperative Anticoagulation in the Setting of Recent Intracoronary Drug Eluting Stents

The purpose of this study is to determine if an intravenous (IV) antiplatelet medication is as safe and effective at preventing clot formation in your stented artery as compared in people who have stopped clopidogrel prior to surgery.

Stent thrombosis continues to be associated with a high rate of death or myocardial infarction. While this risk has been ameliorated through the use of the oral antiplatelet agent clopidogrel, there is a small but important subset of patients who will require discontinuation of clopidogrel due to unplanned or emergency surgery. These patients are exposed to a high risk of stent thrombosis during this time period. It is not known whether a strategy of intravenous antiplatelet therapy to "bridge" these patients is effective at preventing the morbidity related to stent thrombosis in the perioperative period. We intend to assess, in a prospective observational manner, the clinical course of patients who have undergone stent implantation less than 6 months prior to a surgical procedure requiring discontinuation of clopidogrel therapy and the efficacy of intravenous antiplatelet therapy to prevent morbidity related to stent thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or greater, able to give consent
* DES implantation \< or = 6 months prior to admission
* Undergoing an invasive surgical procedure that will require cessation of clopidogrel therapy for \>48 hours

Exclusion Criteria:

* Age \< 18 years
* Refusal to give consent
* Surgical procedure performed without discontinuation of clopidogrel therapy (or \< 48h of clopidogrel cessation)
* Ongoing anticoagulant therapy other than aspirin (i.e. warfarin, ticlopidine)