cyrilzakka/clinical-trials huggingface dataset:
Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification

The aim of this study is to examine whether the same total daily dosage of folic acid, when taken as a single daily dose or as multiple divided doses throughout the day, results in different blood folate and homocysteine levels at the conclusion of the study. Further, a comparison of blood folate and homocysteine levels among women taking daily low-dosage (100mcg) and standard- dosage (400mcg) folic acid with those of women taking daily or weekly high-dosage (4000mcg) folic acid will be conducted.


Eligibility Criteria:
Inclusion Criteria:

-women who have delivered a baby two to four years ago, whose child is still alive, who are not breast-feeding, who are not pregnant or planning to become pregnant within the next 9 months following enrollment, who are using an IUD for contraception, and who have not taken vitamin supplements during the past 3 months

Exclusion Criteria:

-women who have not delivered a baby two to four years ago, whose child is deceased, who are breast-feeding, who are currently pregnant or planning to become pregnant within the next 9 months following enrollment, who are not using an IUD for contraception, and who have taken vitamin supplements during the past 3 months
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy. Summary statistics were presented.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with metastatic, recurrent or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
* Histological or cytological confirmation of hormone-receptor positive (HR+) breast cancer.
* Disease refractory to non-steroidal aromatase inhibitors, defined as:
* Recurrence while on, or within 12 months (365 days) of completion of adjuvant therapy with letrozole or anastrozole, or
* Progression while on, or within one month (30 days) of completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer (ABC).
* Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrolment.
* Patients must have had:
* At least one lesion that could have been accurately measured in at least one dimension

  * 20 mm with conventional imaging techniques or ≥ 10 mm with spiral CT or MRI, or
* Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.
* Adequate bone marrow, coagulation, liver and renal function.
* ECOG performance status ≤ 2.

Exclusion Criteria:

* Patients overexpressing HER2 by local laboratory testing (IHC 3+ staining or in situ hybridization positive). Patients with IHC 2+ must have a negative in situ hybridization test.
* Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites).
* Patients with more than one prior chemotherapy line for ABC. A chemotherapy line is an anticancer regimen(s) that contained at least 1 cytotoxic chemotherapy agent, given for a minimum of 21 days.
* Previous treatment with mTOR inhibitors.
* Known hypersensitivity to mTOR inhibitors, e.g. Sirolimus (rapamycin).
* Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline was not required.
* Patient who were being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
* History of brain or other CNS metastases, including leptomeningeal metastasis.
Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)

The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 18 years of age), or willing and able to provide assent (participants ≥ 12 and \< 18 years of age, where locally and nationally approved) prior to performing study procedures. For participants ≥ 12 and \< 18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures.
* Age ≥ 18 years or aged ≥ 12 and \< 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC))
* Hospitalized with confirmed SARS-CoV2 by polymerase chain reaction (PCR) or known contact of confirmed case with syndrome consistent with coronavirus disease (COVID-19) with PCR pending
* Oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen at baseline
* Alanine aminotransferase (ALT) \< 5 x upper limit of normal (ULN) by local laboratory measure and/or ALT \< 3 x ULN and bilirubin \< 2 x ULN
* Females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Lactating females must agree to discontinue nursing before the study drug is administered and while they are participating in the study

Exclusion Criteria:

* Evidence of multiorgan failure including but not limited to coagulopathy (significant thrombocytopenia), hepatic failure (elevated bilirubin) or renal failure (low urine output or estimated glomerular filtration rate (eGFR) \< 30 mL/min), or significant cardiomyopathy (low cardiac output)
* Use of more than 1 pressor for septic shock (note that use of 1 pressor at low/medium doses for inotropic support due to the use of sedation and paralytics while on the ventilator is allowed)
* Renal failure (eGRF \< 30 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age and Schwartz Formula for participants \< 18 years of age) or dialysis or continuous Veno-Venous Hemofiltration)
* Eligible for enrollment in a randomized clinical trial studying remdesivir for treatment of SARS-CoV2 at the medical facility where the participant is admitted
* Known hypersensitivity to the study drug, the metabolites, or formulation excipient
* Requiring venous arterial (V-A) extracorporeal membrane oxygen (ECMO) (venous venous (V-V) ECMO is not an exclusion criteria)
Exploration of Management Model and Intervention Research on Fear of Cancer Recurrence

1. Through cross-sectional investigation and research, construct an fear of cancer recurrence warning model to identify and screen high fear of cancer recurrencecancer populations, in order to identify predictive factors for high fear of cancer recurrence, study how cancer patients develop susceptibility to fear of cancer recurrence during the diagnosis and treatment process, including which participating factors, explore the development trajectory of fear of cancer recurrence, and effectively prevent the occurrence of high-level fear of cancer recurrence.
2. Through randomized controlled trials, conduct a study on mindfulness and stress reduction psychosocial intervention for high-level fear of cancer recurrence patients, verify the effectiveness of psychosocial intervention measures targeting domestic cancer populations, and improve standardized intervention methods, intervention time, and treatment content.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 18 years old
* Consistent with pathological diagnosis of cancer
* Able to understand and comply with research protocols
* Written informed consent can be provided
* Own and know how to use smart ·terminals (such as smartphones, tablets, computers, etc.)

Exclusion Criteria:

* Patients with mental illness and consciousness disorders;
* Patients with cancer metastasis or recurrence
* End of life treatment for patients.
superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology

The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.

The primary objective of this post-market feasibility study is to confirm the location accuracy of the local registration feature of the superDimension™ Navigation System Version 7.2 in subjects undergoing lung lesion biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. Subject presents with lung lesion(s) 10 mm or greater in diameter amenable to evaluation by ENB at the time of evaluation
2. Lesion is intended to be biopsied by the participating investigator
3. Subject is willing and able to provide informed consent to participate in the study
4. Subject is a candidate for an elective ENB procedure
5. Subject is over the age of 18

Exclusion Criteria:

1. Central lesions that are visible endobronchially or could be reached by a flexible bronchoscope or endobronchial ultrasound (EBUS) without the utilization of ENB
2. Lesions within 10 mm of the diaphragm
3. The subject is unable or unwilling to comply with study follow-up schedule
4. The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
5. Female subjects who are pregnant or nursing as determined by standard site practices
Abdominal Binder Study to Decrease Postoperative Pain

We conducted a controlled randomized trial examining the ability of the Mott abdominal Compression Binder to decrease postoperative pain in gynecologic abdominal laparotomy patients


Eligibility Criteria:
Inclusion Criteria:

* gynecologic abdominal laparotomy patients

Exclusion Criteria:

* non gynecologic abdominal laparotomy patients
Just in Time Intervention to Enhance Physical Activity Among Stroke Survivors

A 3-month single-arm pilot trial to evaluate the feasibility of an automated and individualized coping intervention among stroke survivors.


Eligibility Criteria:
Inclusion Criteria:

1. Adult Patients Diagnosed with Stroke: Participants must be adults (age ≥ 18) who have been clinically diagnosed with a stroke between 3 months and 3 years.
2. Community-Dwelling: Participants should be living independently in the community rather than in institutional settings such as nursing homes or hospitals.
3. Independently Mobile: Participants must be able to walk without any aid or assistance, corresponding to a modified Rankin Scale (mRS) score of 0-2.
4. Physically Inactive: Participants should have engaged in less than 10 minutes of moderate-to-vigorous physical activity (MVPA) in the past week.
5. Internet Access: Participants must have access to the Internet for at least a few hours every day.
6. Medically Cleared to participate: Before enrollment, participants must obtain medical clearance to ensure they are fit to participate in the study.

Exclusion Criteria:

1. Participating in Another Research Project Involving Physical Activity: To avoid potential confounding variables that could affect the study's outcomes.
2. Planning to Move or Have Surgery in the Next 6 Months: Participants who plan to move or undergo surgery within the next six months may face disruptions that could affect their ability to complete the study.
3. Cognitive Impairment: Cognitive impairment can affect a participant's ability to understand and follow study protocols, which is crucial for informed consent and reliable data collection.
A Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus

The aim of this study is to monitor safety and efficacy of treatment with linagliptin in Korean patients with type 2 diabetes mellitus in routine clinical settings.

Study Design:

Post Marketing study- Observational study

Eligibility Criteria:
Inclusion criteria:

Patients who have been started on Trajenta in accordance with the approved label in Korea Patients who have signed on the data release consent form

Exclusion criteria:

Patients with previous exposure to Trajenta and current participation in clinical trials
Azithromycin for Meibomian Gland Disease

This study aims to elucidate the effectiveness of oral azithromycin in treating symptomatic dry eye syndrome secondary to Meibomian gland dysfunction.

This is a randomized, placebo-controlled, double masked trial of the effectiveness of oral azithromycin in treating symptomatic dry eye syndrome secondary to Meibomian gland dysfunction. Dry eye syndrome (DES) is a persistent feeling of ocular discomfort that encompasses dryness, irritation, foreign body sensation and burning. In the United States, it is the most common non-refractive cause of visits to eye care providers, and has been shown to have a significant impact on quality of life of patients who suffer from this condition. most common cause of DES is Meibomian gland disease (MGD). In the vast majority of cases, MGD is not binding, but rather causes persistant ocular discomfort.

Oral antibiotics, particularly the tetracyclines and macrolides, are frequently prescribed for the treatment of MGD. There is little good-quality evidence to support this practice. This study is designed to evaluate the effectiveness of oral azithromycin on patient-reported dry eye symptoms. Concomitantly, we will also study the composition of the ocular surface microbiome in MGD, and its response for oral antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Meibomian gland disease, defined as patient-reported ocular surface symptoms such as dryness, grittiness, foreign body sensation, or eye fatigue in combination with clinically identifiable Meibomian gland disease with Grade 2 or greater involvement on the Meibomian Gland Grading Scale (Section XV, item 2).
* OSDI Score greater than or equal to 20
* Ability to give informed consent

Exclusion Criteria:

* Age less than 18 years
* Allergy or intolerance to oral azithromycin or topical dexamethasone
* Allergy or intolerance to the preservatives used in topical ophthalmic 0.1% dexamethasone: sodium bisulfite, phenylethyl alcohol, benzalkonium chloride
* History of prolonged QT interval, history of torsades des pointes, congenital long QT syndrome, bradyarrhythmias, heart failure
* Patients currently taking medications that prolong the QT interval (Table 1)
* Aqueous deficiency dry eye defined as Schirmer's strip testing without anesthesia with £ 5mm of tears on two separate tests.
* Ocular surface inflammatory disease, including cicatrizing conjunctivitis, graft versus host disease, Stevens Johnson syndrome
* Atopic disease with ocular involvement
* Limbal stem cell deficiency
* Oral or topical ophthalmic antibiotic use within the last 90 days
* Oral prednisone use \>5mg per day
* Topical ophthalmic steroid use within the past 30 days
* Topical ophthalmic anti-inflammatory (including non-steroidal anti-inflammatory medications, lifitegrast, or cyclosporine) use within the past 30 days
* Patients who are currently pregnant, planning on becoming pregnant during the study period, or currently breastfeeding.
KIDNET Versus Meditation/Relaxation - a Dissemination RCTT for Children in Sri Lanka Traumatized by the War and the Tsunami

The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation protocol in treating traumatized children in Sri Lanka when applied by locally trained teacher counsellors.


Eligibility Criteria:
Inclusion Criteria:

* Children with preliminary PTSD diagnosis (except for time criterion) in the age range of 8 to 14 years living in a specific IDP camp after the Tsunami disaster.

Exclusion Criteria:

* Mental retardation, psychosis, any neurological disorder
A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation

To evaluate feasibility of photoplethysmography (PPG) of pulmonary arteries in adults children and neonates and to compare normal controls to premature newborns suffering from patent ductus arteriosus and neonates suffering from pulmonary hypertension.

This study aims to check a new device for measuring lung photoplethysmography (PPG) of pulmonary arteries by delivering light through the chest wall. The aim is to evaluate pulmonary arteries' elasticity and oxygen saturation.

We will study adults children and neonates. We will study 20 healthy adults, 20 healthy children aged 2-8 years, twenty healthy neonates, 20 preterm neonates with patent ductus arteriosus (PDA) and 20 preterm neonates with no PDA. We will study also 20 neonates with pulmonary hypertension.

Each participant will be examined for 5 minutes and PPG signal will be recorded in a computer and evaluated offline later on. Pulmonic saturation will be calculated from absorption difference between two wave lengths of infrared light that will be used.

Our hypothesis is that the mentioned clinical conditions will affect PPG signal and pulmonary arterial oxygen saturation.

Eligibility Criteria:
Inclusion Criteria:

* Hemodynamic stability

Exclusion Criteria:

* hemodynamic instability
Safety and Efficacy of Lansoprazole in Patients With Reflux Disease

The purpose of this study is to measure the safety, efficacy and quality of life of lansoprazole in patients with reflux disease over a five year period.

Lansoprazole is currently approved in Germany for the treatment of erosive reflux esophagitis and active duodenal and gastric ulcer disease, and for long-term treatment including maintenance of healed reflux esophagitis and duodenal ulcer disease and treatment of pathological hypersecretory conditions such as Zollinger-Ellison syndrome.

This study was conducted to evaluate the safety, efficacy and quality of life of patients receiving up to five years of treatment with lansoprazole.

Eligibility Criteria:
Inclusion Criteria:

* Had Gastro Esophageal Reflux disease with or without oesophagitis.
* Had a history of heartburn at least for 5 days per week during the past 6 months or was receiving long-term treatment with a proton pump inhibitor and during two weeks (without proton pump inhibitor treatment) prior to enrolment.

Exclusion Criteria:

* History of surgery of stomach or oesophagus.
* Gastric ulcer (can be included after healing of gastric ulcer).
* Duodenal ulcer (can be included after healing of duodenal ulcer).
* Bleeding (melena, hematemesis).
* Severe concomitant disease (cancer, cardiovascular, renal, hepatic diseases).
* Barrett oesophagus with dysplasia.
* Complicated esophagitis (oesophageal strictures or ulcers).
* Treatment with proton pump inhibitor or Histamine receptor 2 (H2)antagonists within the previous two weeks.
* Pregnancy, wish to become pregnant, breast feeding.
* Treatment with non steroidal anti-inflammatory drugs, treatment with acetylsalicylic acid (aspirin) \> 100 mg/day.
Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia

An effective and safe medical therapy would be most welcome to reduce the need for surgical interventions and related adverse events and psychological impact on patients with cervical cancer precursors. In this clinical trial, the investigators propose to evaluate the efficacy and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to moderate-grade CIN (grade 1-2).


Eligibility Criteria:
Inclusion Criteria:

* Patients with ectocervical CIN1 or CIN2 as verified by local pathology (biopsy) obtained within the last month
* Satisfactory colposcopy examination including:

  * visibility of entire transformation zone including the squamocolumnar junction and
  * visibility of entire lesion margin
* Negative endocervical os by colposcopy
* Colposcopical visible lesion at visit 2, before treatment
* Patients with an average sized uterine cervix (approximately 27mm diameter) suitable for application of the Klemcap
* Age 18 or above
* Written informed consent signed

Exclusion Criteria:

* Previous treatment of CIN or invasive disease
* Lesion(s) extending to the vaginal vault
* Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology, malignant cells on cytology or histology or other suspicion of either micro-invasive or invasive disease
* Suspicion of endocervical disease on colposcopy
* Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per colposcopy and clinical examination
* Undiagnosed vaginal bleeding
* History of toxic shock syndrome
* Known or suspected porphyria
* Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
* Pregnancy, or intention to become pregnant during the study period
* Nursing
* Childbirth or miscarriage within six weeks of enrolment
* Use of heart pacemaker
* Participation in other clinical studies either concurrently or within the last 30 days
* Risk of poor protocol compliance. Patient participation should be considered with respect to living far away from the hospital, plans for moving to another city/state, frequent travelling, planning to become pregnant, drug abuse/alcoholic, difficult working hours, family obligations, other illness (e.g. psychiatric), etc.
* Unwillingness to use adequate birth control (not abstinence) from screening until last PDT
* Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
Effects of Peripheral Magnetic Stimulation

Interventional study of the effectiveness of peripheral magnetic stimulation of the abdominal wall muscles in healthy individuals.

Interventional 8-week study of the effectiveness of peripheral magnetic stimulation of the abdominal wall muscles in healthy individuals. The study will include an experimental and a control group.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults
* BMI between 25,0 and 29,9 kg/m2
* stable body mass with maximal variation of body mass of 2.2 kg a month prior to the inclusion in the study
* waist circumference above 80 cm for females and above 90 cm for males

Exclusion Criteria:

* invasive fat reduction procedures (e.g., liposuction and mesotherapy)
* weight loss supplements in the month prior to the participation in the study
* metal implant
* active implanted electrical device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system
Laparoscopy Combined With Enhanced Recovery Pathway

Laparoscopy combined with an enhanced recovery pathway versus laparoscopy combined with a traditional recovery pathway after ileocolon resection for Crohn's Disease.

Thirty patients with CD of ileocolon will be randomly assigned to two groups.One group is ERP group which include no bowel preparation nor fasting, no abdominal drains, early removal of urinary catheter, early solid dietary intake and mobilization and restrictive fluid management.In the end,we can compare the time to first flatus、time to first flatus 、postoperative length of stay postoperative hospital expense、complication grade readmission within 30 days of discharge between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years≤aged≤75 years) were included if they had histologically or radiographic proven CD with disease localized to the terminal ileum with or without ascending colon involvement.

Exclusion Criteria:

* Those patients were excluded：previous bowel resection or strictureplasty, preoperative radiological evidence of large phlegmons/abscesses/enteric fistulas (assessed by magnetic resonance imaging or computed tomography), emergency surgery, and anesthesiological contraindications to laparoscopy.