cyrilzakka/clinical-trials huggingface dataset:
An Open Label Access Study For Subjects Who Completed A1481156

The purpose of this study is to provide sildenafil therapy to subjects who have completed the A1481156 study for the treatment of Pulmonary Arterial Hypertension (PAH) in India and are judged by the Investigator to derive clinical benefit from continued treatment with sildenafil citrate. Sildenafil citrate will be supplied for the treatment of Pulmonary Arterial Hypertension (PAH) until the subject continues to derive benefits from the treatment. The treating physicians (and the sponsor) will be responsible for reporting serious adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed study A1481156 and are judged by the Investigator to derive clinical benefit from continuous treatment with sildenafil citrate therapy.
* Subjects with pulmonary arterial hypertension (PAH ) being treated at a study site in India
* Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures

Exclusion Criteria:

* Pregnant or lactating female subjects.
* Current participation in other studies and during study participation, except for the A1481304 follow-up period.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
PillCam Colon Capsule Endoscopy for Ulcerative Colitis

Pillcam colon capsule (PCC) endoscopy is a novel strategy tool to inspect colon mucosa. The aim of the present study is to evaluate if PCC endoscopy is able to precisely investigate patients with ulcerative colitis and reach high consistency to conventional colonoscopy.

Symptomatic patients with confirmed ulcerative colitis (UC) were enrolled in this prospective single-center study. No sooner had patients gone through Pillcam colon capsule (PCC) endoscopy solution than they got conventional colonoscopy which is recognized as the "gold standard" examination technique. The extent of mucosal damage and inflammatory lesions during both modalities were recorded for comparison. In addition, the regimen of bowel preparation, completion rate, colonic cleanliness, compliance or adverse events were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged 18-70)
* Ulcerative Colitis history
* Suffering from symptoms such as hematochezia, diarrhea or abdominal pain

Exclusion Criteria:

* Patients with a high risk for capsule retention (such as intestinal diverticula, acute abdominal pain without regular defecation indicating intestinal obstruction or a history of abdominal operation or intestinal reconstructed operation),
* Patients allergic to sodium phosphate or polyethylene glycol (PEG) solution,
* Patients with a history of Crohn's disease
* Patients with serious systematic diseases such as congestive heart failure, renal failure or severe liver disease.
Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer

This is a study to determine the prevalence and severity of alopecia (hair loss) experienced by postmenopausal breast cancer patients receiving endocrine therapy including Tamoxifen, Letrozole (Femara), Exemestane (Aromasin), or Anastrozole (Arimidex).


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Diagnosed with hormone-receptor positive breast cancer
* Commenced adjuvant endocrine therapy ≥ 3 months ago, specifically Tamoxifen, Anastrozole, Exemestane, and/or Letrozole
* Good command of the English language
* Under the care of a medical oncologist at Princess Margaret Hospital

Exclusion Criteria:

* Previously received chemotherapy
* Recurrent and/or metastatic disease
* History of endocrine, dermatology, or immune system disorders known to alter hair growth (ie. Hypothyroidism and iron deficiency)
Computer-based Dosage Calculation for Antibiotics

Adequate dosing of antiinfective therapy in critically ill patients with impaired or lost renal function or continuous renal replacement therapy is nearly impossible without measuring the drug concentration in blood samples. In many hospitals that is still not an option. The investigators aim to show, that computer based calculation can avoid over- or under-dosing.

Adequate dosing of antiinfective therapy in critically ill patients is most important to improve outcome. Patients with impaired or lost renal function or continuous renal replacement therapy are hard to calculate using drug information sheets or "lists" with recommendations. It is nearly impossible to avoid drug levels that are much to low or much to high without measuring the concentration in blood samples. Since that possibility is still not available in every clinic we aim to show, how a computer based calculation can help to find the adequate dosing.

Eligibility Criteria:
Inclusion Criteria:

* patients requiring antiinfective therapy
* patients with impaired renal function or requiring continuous renal replacement therapy

Exclusion Criteria:

* plasmapheresis or liver replacement therapy
* renal replacement therapy with integrated CytoSorb®-Membrane
* extracorporal live support
The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population

This study was conducted to explore whether the non-synonymous single-nucleotide polymorphisms in SCN9A gene can predict individual basal pain perception and postoperative pain intensity in the general population undergoing upper abdominal surgery. Methods: Patients receiving elective upper abdominal surgery under general anesthesia were recruited into this study. Genotyping of SCN9A was carried out by direct sequencing. The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h ,24 h and 48h after operation. And the PCA press frequency and drug consumption were recorded.

Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20-70 years
* Receiving elective upper abdominal surgery
* Anesthesiologists (ASA) physical status I or II
* Received PCA administration
* Agreed to participate the research

Exclusion Criteria:

* History of chronic pain
* Psychiatric diseases
* Diabetes mellitus
* Severe cardiovascular diseases
* Kidney or liver diseases
* Alcohol or drug abuse
* Heavy smoker
* Pregnancy or at lactation period
* Refused PCA administration
* Disagree to participate to the research
Development of a Clinical Trial Specific Question Prompt List

The purpose of this study is to develop a Question Prompt List (QPL) about clinical trials for cancer patients and find out what cancer patients and their caregivers think of the QPL. A QPL is a list of questions patients might want to ask their doctors during their appointments.

We will conduct three focus groups to talk about using QPL's as a new way to recruit patients like you to clinical trials. The three groups will be made of patients who have and have not participated in clinical trials, their caregivers and doctors. This study is also being done to learn about how the QPL affects the question asking behavior of patients during their appointments with doctors at Memorial SloanKettering Cancer Center (MSKCC).


Eligibility Criteria:
Inclusion Criteria:

* Population Segment 1 who have participated in a clinical trial
* Diagnosis and treatment at MSKCC of lung, prostate or breast cancer
* Completion of a Phase I, II, or III clinical trial at MSKCC
* Ability to provide informed consent

Patient caregiver eligibility requirements will be:

* Nomination by patient as the primary caregiver
* Ability to provide informed consent

Population Segment 2 who have not participated in a clinical trial:

* Diagnosis and treatment at MSKCC of lung, prostate or breast cancer or the primary patient caregiver
* Ability to provide informed consent

Patient caregiver eligibility requirements will be:

* Nomination by patient as the primary caregiver
* Ability to provide informed consent

Population Segment 3 who are health care professionals:

* A current health care professional at MSKCC
* Current involvement in recruiting patients with lung, prostate or breast cancer to Phase I,II, or III clinical trials at MSKCC
* Ability to provide informed consent

Exclusion Criteria:

Potential subjects will be considered ineligible for either/both phases of this study if they are:

* Fewer than 18 years of age
* Cognitively or physically impaired, rendering them incapable of providing informed consent to participate in the study
* Population Segment 2 participants will be excluded if they have ever participated in a clinical trial.
Project HOPE 1000: Health Outcomes Pregnancy Exposures

The purpose of this study is to collect biological samples from pregnant women and their babies and to collect data on long-term health, school outcomes, and the use of state and county services. The information learned from this study may help identify important factors that may influence the health of mothers and babies, both short-and long-term.

Humans pass through more biological milestones during gestation and the first two years of life (known as the "first 1000 days") than during any other period of development. Consequently, both intrinsic biology/physiology and extrinsic factors such as environmental exposures can have profound impacts on long-term health and disease outcomes. The purpose of this project is to develop a cohort of mother-infant dyads that can provide a collection of birth samples and be studied long-term - from pregnancy through early childhood - to help identify early life factors that influence lifelong health and disease. The study will include collection of specimens from pregnant women during each trimester of pregnancy, at delivery, and within the first few months after giving birth, as well as collection of specimens from the infants at birth and during their first two years of life. In addition to specimens, health information will be collected from the participants' electronic health records, and via questionnaires to assess health behaviors, social determinants, and environmental exposures. Participants may also consent for yearly review of state administrative data, including educational data, social services, and vital records. The specimens and data collected in this study will allow for assessment of the impact of different factors during pregnancy and early childhood on long-term health and well-being.

Eligibility Criteria:
Inclusion criteria:

* The subject has provided a signed Informed consent prior to any study procedures.
* Maternal age at consent of ≥ 18 years old
* Ability to understand English or Spanish
* Willingness to comply with and be available for all protocol procedures
* Singleton gestation \< 24 weeks 0 days
* Receiving prenatal care at a Duke-affiliated Obstetrics clinic with the intent of delivering at Duke University Health System-affiliated hospital (including Duke University Hospital and Duke Regional Hospital)
* Plans to have their infant seen at a Duke-affiliated Pediatrics practice after birth
* Plans to remain in the area for two years after delivery

Exclusion criteria:

* Non-viable pregnancy
* Having any condition that, in the opinion of the site investigators, would place the subject at unacceptable risk of injury or confound data interpretation
Childhood B-acute Lymphoblastic Leukaemia and Role of CD9 Gene Regulation in Relapse

B-acute lymphoblastic leukaemia (B-ALL) is the most common cancer in children, with 20% of patients relapsing. CD9, a transmembrane protein, is linked to the migratory and adhesion capacities of leukaemia cells and could be associated with relapses. The aim of this project is to understand how CD9 regulation can be a marker of potential relapses, using bone and blood sampling of newly diagnosed patients at 3 crucial moments of therapy.

B-acute lymphoblastic leukaemia (B-ALL) is the most common cancer in children, with 20% of patients relapsing despite major therapeutic advances. A research team of the Development and Genetic Institute in Rennes has identified that the expression of CD9, a transmembrane protein, is linked to the migratory and adhesion capacities of leukaemia cells, enabling them to persist in niches such as the testis. CD9-associated relapses often arise from these niches. Understanding the regulation of CD9 expression is therefore essential.

The hypothesis on which this project is based is that CD9 expression could be orchestrated by ncRNAs. Due to the complexity of deciphering circRNA-miRNA-mRNA networks, an exploration of patient blasts is envisaged in order to delineate a specific non-coding RNA network regulating CD9 expression from bone marrow and blood samples of paediatric-aged patients with B-ALL. If this hypothesis is confirmed, the ncRNAs identified could constitute new specific diagnostic and prognostic markers, or even therapeutic targets.

To confirm this hypothesis, bone and blood sampling of newly diagnosed patients will be collected at the diagnosis, after first phase of treatment and at the relapse, if it occurs.

Eligibility Criteria:
Inclusion Criteria:

* Under 18 years
* With established diagnosis of B-ALL
* Initial diagnosis made in the investigating centre
* Having received oral and written information about the protocol, or oral only if the patient is unable to read.
* Having signed a consent form if the patient is capable of giving informed written consent.
* Whose legal guardians have received oral and written information about the protocol, and have signed a free, informed and written consent.
* Beneficiary of a social security scheme

Exclusion Criteria:

* Isolated extramedullary involvement at inclusion
* Patient of childbearing age without effective contraception.
* Adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty.
Dose Finding Evaluation of Kudzu Root Extract in Women With Menopause Symptoms

The aim of the study is to investigate effects of daily intake of Nordic Kudzu for 28 days in 5 groups of 10 menopausal women with symptoms. Groups:1) 3 capsules x3/day, 2) 3 capsules x2/day, 3) 2 capsules x3/day, 4) 2 capsules x2/day, 5) 3 capsules x1/day. Each capsule equal 1.26 g kudzu root extract. Outcome measures: Serum and urine levels of biochemical marker of bone-degradation, CTX-I, and symptoms of menopause using the Meopause Rating Scale (MRS).


Eligibility Criteria:
Inclusion criteria:

1. Signed and dated informed consent
2. Women in the age between 45 and 60 years considered late peri- (defined as having had a menstrual period more than 3 months ago but less than 12 months ago) or postmenopausal (defined as at least 12 consecutive months without any menstrual flow) at the time of screening
3. Menopause symptoms, defined as a score of at least 5 in the Menopausal Rating Scale (MRS) at screening
4. Body Mass Index between 18 and 40 kg/m2 at the time of screening

Exclusion criteria:

1. Allergy/hypersensitivity/intolerance to any components in the Kudzu herbal extract powder capsules
2. Past or present significant co-morbidity including, but not limited to: Uncontrolled, severe renal, hepatic, cardiovascular, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease
3. History of breast cancer or other malignancy, except adequately treated basal cell or squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
4. Known history of clinically significant thromboembolism
5. Current alcohol abuse
6. Pregnancy, determined by positive serum human chorionic gonadotropin (hCG) test prior to randomization, except for women considered postmenopausal
7. Breastfeeding women
8. Participation in a study trial with any investigational new drug or food supplement within 3 months prior to the start of the study
9. Clinically significant ECG abnormalities, as judged by the investigator
10. Clinically significant biochemistry abnormalities including but not limited to ALT or AST \>2.5 x ULN or other clinically significant liver function parameters, as judged by the investigator
11. Investigator considering the subject inappropriate for inclusion in the study based on medical interview and/or physical examination
12. Use of local or systemic conventional hormone therapy regardless of indication or alternative medication including dietary supplements for the treatment of menopausal symptoms within 28 days prior to randomization.
Development and Validation of a Digital Twin-based Clinical Research System (X Town Stage I)

Chronic diseases, characterized by their prolonged duration and slow progression, have emerged as predominant contributors to global morbidity and mortality. The investigators have developed a digital twin-based clinical research system (termed X Town) for chronic diseases, to predict clinical outcomes under various interventions. In this study, the investigators aim to evaluate the reliability of the developed digital twin-based clinical research system in predicting short-term clinical outcomes via virtual and real-world clinical studies.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years old
2. Receiving care at a community health service centre
3. Able to understand and comply with the study procedures
4. Agrees to participate in the study and signs the informed consent form

Exclusion Criteria:

1. Patients with severe mental illness
2. Patients expected to be unable to complete follow-ups
A Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication

The investigators seek to determine whether Virco®TYPE HIV-1 provides benefits equivalent to those provided by local expert review. The investigators propose that clinic patients of the Ruth M. Rothstein CORE Center who are having genotypic testing performed will be randomized in a 1:1 fashion to local expert review and to Virco®TYPE HIV-1. Results of either method will be shared with primary HIV care providers. Patient outcomes will be reviewed at a time point equal to or greater than 2 months and 6 months following the change in antiretroviral medications following the testing

Patients having some documented genotypic HIV resistance but having more than one fully active medication will be randomized to either local review or algorithmic review by VircoType HIV-1.

Eligibility Criteria:
Inclusion Criteria:

* HIV resistance testing that demonstrates resistance to at least one drug
* Patients of the CORE Center, Chicago Illinois

Exclusion Criteria:

* Wild type HIV on resistance testing or less than or equal to one active antiretroviral medication
Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients

Detailed study of ultrasonographic caudal epidural anatomy

Caudal epidural block is one of the most common methods to provide analgesia for an infraumbilical surgery in children. Although it can be carried out safely and easily, many complications have been described so far, because of inaccurate needle injections. To perform a successful block, a good caudal epidural anatomic assessment is essential. Ultrasonography is an important tool to perform pediatric regional blocks, including caudal blocks. We believe that caudal epidural ultrasound evaluation can be an important option to decrease complications and to achieve a successful attempt; due to that we will try to describe caudal epidural ultrasound imaging and changes from one month to 84 months.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients who applied for any pediatric surgery from 20 january to 20 july

Exclusion Criteria:

* Premature patients
* Patients who have any sendromic diagnosis
* Patients who have any musculoskeletal abnormalities
* Patients who have any spinal abnormalities
I125 Brachytherapy After TURP

Low dose rate brachytherapy using iodine 125 is well established as a treatment for low and intermediate risk prostate cancer. Currently there is uncertainty as to the safety of this technique in patients who have had a previous transurethral resection of the prostate gland (TURP) for obstruction of the urine flow through the prostatic urethra. Early experience when the technique was being developed in the 1980s suggested that there was a higher incidence of urinary incontinence after brachytherapy if there had been a previous TURP. It is however clear that with increasing experience many centres offer this treatment to patients who have had previous TURP, using various parameters to select patients including time from the TURP and persence or absence of a significant cavity within the gland on MRI scanning. There has been no systematic study of I125 brachytherapy after TURP in the current era which might address and inform the practice for future patient. Hence this study is designed to formally assess the safety of I125 brachytherapy after previous TURP.


Eligibility Criteria:
Inclusion Criteria:

* WHO performance status 0-1
* No contra-indication for anaesthesia
* No history of irradiation of the pelvis
* No other oncologic malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient is disease free for at least 5 years.
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;

Prostate (cancer) related:

* Histologically proven prostate cancer (adenocarcinoma) of low or intermediate risk following the D'Amico classification.
* Prostate volume \< 50 cc as measured on transrectal ultrasound
* Neo-adjuvant antiandrogen hormonal treatment is permitted to downsize the prostate volume or to cover waiting time till brachytherapy procedure. No adjuvant hormonal treatment is permitted.
* History of TransUrethral Resection of the prostate (TURp), performed at least 3 months before the brachytherapy procedure.
* Rim of prostate tissue of at least 1 cm around the post-TURp urethral defect at thepostero-lateral sides of the prostate
* Absence of significant TURp-induced urinary incontinence
* IPSS \<15

Exclusion Criteria:

* Locally advanced (stage T3 or T4 , or metastatic (stage N+ or M+) prostate cancer High grade tumours defined by Gleason score 8 or above Co-morbidity which would exclude the patient from a transperineal implant procedure.

Unable to give informed consent.