cyrilzakka/clinical-trials huggingface dataset:
Safety of Total Daily Doses of Polyethylene Glycol (PEG) 400 Administered Orally to Healthy Male Human Subjects

To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
* Age ≥ 18 and ≤ 55 years
* Broca ≥ - 20 % and ≤ + 20 %

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram \[ECG\]) deviating from normal and of clinical relevance
* History of current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
* History of orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within one month prior to administration
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within one month prior to administration or during the trial
* Smoker (\> 10 cigarettes or three cigars or three pipes/day) or inability to refrain from smoking 10 hours before the morning dose and one hour before afternoon/evening dose and one hour after any dose
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation within one month prior to administration or during the trial
* Excessive physical activities within five days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range and of clinical relevance
Registry of Bleeding Risk in Real World Chinese Acute Coronary Syndrome Patients-II

The present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.

Acute coronary syndrome (ACS) is a group of clinical syndromes characterized by rupture or erosion of coronary atherosclerotic plaques secondary to complete or incomplete thrombus formation.

With the development of antithrombotic drugs and percutaneous coronary interventional therapy, bleeding has become one of the major complications for ACS patients after PCI.Moreover,Bleeding after PCI therapy significantly increased short-term and long-term risk of death.

However, there is a lack of data on the risk of bleeding in ACS patients treated with PCI in the clinical reality world of china.

Therefore,the present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.

The present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.

This study will provide sufficient and reliable evidence for the risk of bleeding and the choice of antithrombotic drugs in ACS patients undergoing PCI in China, and provide a reference for individual antithrombotic therapy after PCI.

Eligibility Criteria:
Inclusion Criteria:

* age≥18 years, male or female;
* confirmed acute coronary syndrome patients;
* undergo percutaneous coronary intervention (PCI) treatment;
* agree to participate in this clinical study and sign a written consent form.

Exclusion Criteria:

* ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure;
* patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements;
* pregnant women or lactating women;
* investigators consider patients who were not suitable for participation with other reasons
Prevalence and Risk Factors in Unipolar Depression Patients Without Remission After One Antidepressant Trial

A non interventional, descriptive, longitudinal cohort study is designed, trying to obtain local data about the prevalence of non remitted depressed patients after an antidepressant treatment, and to get information about sociodemographic and clinical characteristics of these patients as well as features of their treatments and compare them with those of the patients that achieve remission. Also the effect of patient´s expectation in the treatment outcome will be examined.

A non interventional, descriptive, longitudinal cohort study is designed, trying to obtain local data about the prevalence of non remitted depressed patients after an antidepressant treatment, and to get information about sociodemographic and clinical characteristics of these patients as well as features of their treatments and compare them with those of the patients that achieve remission. Also the effect of patient´s expectation in the treatment outcome will be examined.

Non psychotic depressed patients that are initiating an antidepressant treatment will be recruited. Socio demographic and clinical features will be recorded as well as their expectations before the treatment. Severity of depression and treatment characteristics will be recorded after 4 to 8 weeks of drug treatment at an adequate dose. Variables will be compared between the patients that will achieve remission and those that do not.

Eligibility Criteria:
Inclusion Criteria:

Female and male aged 18 to 75 years old. Outpatients with a current episode of non-psychotic unipolar major depression according to the DSM IV-TR.

Severity of illness assessed by means of a score ≥ 14 in the HAM D17 Have not been medicated for the current depression episode with an antidepressant Provision of subject informed consent

Exclusion Criteria:

Patients participating in any clinical trial, the subject cannot take part in this study.

The individual has participated in the last 3 months (including this study) or is participating in a clinical trial.
Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.


Eligibility Criteria:
Inclusion Criteria:

* Women \> 18 years old
* English-speaking
* Stage \> 2 pelvic organ prolapse
* Undergoing pelvic organ prolapse procedure (including native tissue vaginal procedure, native tissue laparoscopic procedure, mesh-augmented laparoscopic procedure, obliterative procedure)
* Planning overnight stay

Exclusion Criteria:

* Renal dysfunction (creatinine clearance \<60 mL/min)
* Allergy to acetaminophen and ibuprofen
* Allergy to gabapentin
* Patients on a Controlled Substance Agreement or Opioid Contract from another provider. This information is available in the IU Health electronic medical record, Cerner.
Comparison of Keloid Volume and Symptoms Reduction Between Intralesional Umbilical-Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide Injection as Keloid Therapy: A Randomised Controlled Trial

This study is a double-blind randomized controlled trial (RCT) examining the effect of intralesional injection of umbilical cord-derived mesenchymal stem cells (UC-MSC), umbilical cord-derived conditioned medium (UC-CM), or triamcinolone acetonide (TA) on keloids carried out using CONSORT statement. Research is directed at studying keloid volume reduction and changes in POSAS score.

Patients were screened initially by measuring the length and thickness of the keloids using a ruler. Patients who met the study inclusion criteria were randomly divided into three groups. Each patient in the groups was given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure. Group 1 was given umbilical cord-derived mesenchymal stem cells (UC-MSC) 2 million cells/mL/cm3, group 2 was given umbilical cord-derived conditioned medium(UC-CM) 1 mL/cm3, and group 3 was given triamcinolone acetonide (TA) 40 mg/mL/cm3. All patients received a single dose and 1 booster dose. The percentage of keloid volume regression in each treatment group was calculated by calculating the difference in volume before and after therapy with a 3-dimensional CT-scan, then expressed as a percentage. The CT-scan volume was obtained with the SmartVitrea application (Figure 2), then a POSAS examination will be carried out for subjective and objective assessment.

Eligibility Criteria:
Inclusion Criteria:

* The patient has keloids with a length of 2-10 cm and a thickness of 3-5 mm located on the chest, back, abdomen and extremities
* Patients aged 18 - 55 years
* Post-surgery patients more than 3 months that cause keloids
* The patient is willing to fill in the informed consent form

Exclusion Criteria:

* Patients with hypertrophic scars
* History of kidney failure
* Hypertension
* Pregnant and breastfeeding
* History of blood disorders
* History of tumor or malignancy
* Get other keloid therapy outside of the research procedure
Melatonin as Adjuvant Therapy in Breast Cancer Patients

The study evaluate the effect of melatonin in improving quality of life and reducing post operative pain and chemotherapy-induced toxicity in breast cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in stage II or III breast cancer patients. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into two groups: melatonin 20 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first night prior to surgery and continue for 24 months. Standard treatment is surgery followed by chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT-B), pain (VAS 0-10), adverse event frequency, sleep quality (VAS 0-10), recurrence rate and progression-free survival.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven stage II or III breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
* platelet count ≥100,000 cells/mm3
* white blood cell count ≥ 3,000 cell/mm3
* hemoglobin ≥ 10 g/dL
* serum creatinine ≤ 1.5 mg/dL
* bilirubin ≤ 2 mg/dL
* AST ≤ 2.5 times upper limit of normal (ULN)
* New York Heart Association grade ≤ 2
* written consent

Exclusion Criteria:

* received prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization,
* had more than one type of cancer or brain metastasis
* moderate neuropathy (CTCAE grade ≥ 2)
* active infection
* uncontrolled complications (i.e. blood glucose \> 200 mg/dL, uncontrolled hypertension, unstable angina, history of congestive heart failure or history of myocardial infarction within one year).
Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes

125 children with Type 1 Diabetes mellitis (T1DM) between 4 and 16 were recruited and 62 healthy siblings also enrolled in the study.

Children with T1DM and sibling controls ages 4 to 16 were assessed on memory and executive control skills at entry to the study (Test 1) and after two years of close monitoring for blood sugar events (Test 2). Diabetic children have their blood sugar tested directly before and after cognitive testing to ensure their blood sugar is within range during the testing. The 2-year follow-up period involves parents/child reporting any severe diabetic episode and periodically providing the results of the diabetic child's usual blood tests from their glucose monitoring device.

Children 7 and older also underwent high resolution MRI scans.


Eligibility Criteria:
Inclusion Criteria:

* Age 4 - 16 (for MRI, must be 7 or older)

Exclusion Criteria:

* Pregnant or lactating (females 13+)
* Chronic disease other than T1DM, well-controlled asthma, or Hashimoto's thyroiditis. (Exclude for hypothyroidism)
* Other current serious medical illness
* Co-morbid psychiatric illness: such as mania, ADHD, LD, major depression, mental retardation, or psychoactive drug dependence
* Co-morbid neurological illness: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries (i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness
* EXCEPT T1DM-related
* Pre-maturity at birth \>4 wks early (\<36 wk term) w/ sequelae e.g. on respirator at NICU
* Use of psychoactive medications or exposure to neuroleptics (except that exposures of less than 1 month, occurring more than 5 years ago, will be allowed) or pts. w/recent tx w/dopamine depleting agents or stimulants such as Ritalin, Cylert, Adderall
* Contraindication to MRI scan (e.g. claustrophobia, metal implants, foreign bodies) - N/A if \< 4 years old
* Full set (top and bottom) orthodontic braces. (Half set braces, fillings, and retainers are OK)
Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
* Diagnosis of T2DM for at least 4 weeks prior to study entry
* Age 18 - 78 years inclusive
* Body mass index (BMI) of 22 - 40 kg/m2
* HbA1c: 7.5 - 11% inclusive
* FPG \<270 mg/dL (15 mmol/L)

Exclusion Criteria

* Pregnant or lactating female
* A history of type 1 diabetes
* Evidence of significant diabetic complications
* Other protocol-defined inclusion/exclusion criteria may apply
An Open, Uncontrolled Study of GK567 in the Deodorization of Malodorous Fungating Neoplastic Tumours

This clinical trial objective is to investigate the safety and efficacy of GK567 to alleviate malodour of foul smelling, anaerobically infected fungating neoplastic tumours, over 14 days of treatment.

The clinical hypothesis is that the success rate is no worse than 70% in the population of interest, where success for a patient is defined as a smell score of 0 or 1 at Day 14/end of treatment, as assessed by the Study Investigator.


Eligibility Criteria:
Inclusion Criteria:

* The subject is a male or female aged between 20 years or older.
* The subject has a cutaneous fungating neoplastic tumour with a smell that suggests established or early infection, with a minimum score of 2 (i.e. mildly offensive smell) on a 0-4 smell scale, (based on the Study investigator's assessment)

Exclusion Criteria:

* The subject is currently receiving systemic antibiotics or received in the last 2 weeks,
* The subject is currently receiving systemic or topical Metronidazole or received in the last week,
* The subject is currently receiving topical antibiotics or received such treatment applied on cutaneous fungating neoplastic tumour in the last 1 week,
* The subject already receives any topical treatment on the cutaneous fungating neoplastic tumour
Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

The purpose of this study is to determine whether patients with Hashimoto thyroiditis and impaired well-being may have a partial secondary adrenocortical insufficiency.

Many patients with Hashimoto thyroiditis who are correctly substituted with thyroid hormones have an impaired well-being. in some people an isolated ACTH deficiency was found.

In this study a 1 µg ACTH test is performed to evaluate the adrenocortical function.

Eligibility Criteria:
Inclusion Criteria:

* Hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written informed consent

Exclusion Criteria:

* • hypothyroidism of other origin

  * pregnancy and lactation
  * oral contraception
  * glucocorticoid therapy during the last 2 months
  * History of malignancy or chronic infections (Hepatitis, HIV)
MOMSonLINE2 ; A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers

This is a 6-week pilot study to see how research participants feel about an internet support site after a stillbirth or infant death. Losing a baby through stillbirth or early infant death is typically devastating for families. However, investigators do not know if internet on-line support for parents helps manage grief more easily.

In addition to using the BabyCenter.com website, participants will be asked to complete online surveys at the beginning and the end of the study, as well partake in an interview.

Data from this pilot study will help develop a much larger randomized control study of on-line support outcomes after perinatal loss.


Eligibility Criteria:
Inclusion Criteria:

* Michigan residence and infant delivery
* Non-Caucasian race and/or Hispanic ethnicity
* Read/speak English
* Gave birth to a stillborn baby or had an infant death in the first 28 days of life
* Did not give the baby up for adoption pre-loss
* Internet access

Exclusion Criteria:

* Don't Read/speak English
Clinical Evaluation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression

This study will be a 2 year, double-masked, randomized, controlled mono-center monocular exploratory clinical investigation to test and compare the efficacy of the test lens in slowing down the increase of axial length and controlling myopia progression.

The clinical trial aims to assess the efficacy and safety of a test lens, designed to emit red-light when exposed to natural daylight that can produce a cumulative red-light exposure equivalent to the sham device (Dong et. al, 2023) when children spend about 30 minutes in a day. The primary goal of this clinical trial is to evaluate the effectiveness of the test lens in slowing down the increase of axial length and controlling myopia progression compared to the reference lens design.

Eligibility Criteria:
Inclusion Criteria:

* Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.
* Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.
* Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.
* Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen).
* Be in good general health, based on his/her and parent's/guardian's knowledge.
* Agree to wear spectacles for \>12 hours/day and at least 6 days/week.
* Willingness and ability to participate in investigation for 2 years and attend scheduled visits.

Exclusion Criteria:

* Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.)
* Any binocular vision anomalies
* Amblyopia
* Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month.
* Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
* Participation in any clinical investigation within 30 days of the baseline visit.
Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease

This study will compare the safety and efficacy of TrueTear™ to standardized moist heat compress (Thermalon® Dry Eye Compress) for the treatment of Meibomian Gland Disease (MGD).


Eligibility Criteria:
Inclusion Criteria:

* Dry eye disease or Meibomian Gland Disease as evaluated by Standard Participant Evaluation for Dryness (SPEED) score, Schirmer test, Tear film breakup time and other applicable objective measures at the Screening and Baseline Visits.
* Use of an artificial tear product, lid hygiene, omega-3 supplementation, antibiotics for the treatment of dry eye disease or Meibomian Gland Disease within one year of the Screening Visit.

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding.
* History of nasal or sinus surgery.
* Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit.
* Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of the Screening Visit.
* Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head.
Preoperative Stent Study

Randomized study comparing the effect of plastic stents to that of expandable metal stents as pre-operative drainage of the bile ducts prior to Whipple operation.

Patients suffering from a locally invasive tumour process in the Periampullary area usually seek medical attention because of jaundice. Not only do patients suffering from jaundice show significant symptoms of exhaustion and purities, but they are also at higher risk for developing post-operative complications. Experimentally, the liver exhibits a reduced capacity for tolerating ischemia in the presence of jaundice. Several different etiologic factors suggest cause complication such as presence of toxic substances as bilirubin and bile salts, impaired nutritional status, effects of endotoxins, bacterial translocation, modulation of the inflammatory cascade with cytokine release, reduction of cellular immunity and nutritional. These complications primarily consist of septic complications (cholangitis, abscesses, and leakage), haemorrhage, impaired wound healing and renal disorders. Summarily, these issues have motivated pre-operative bile flow drainage by way of stent. Traditionally, pre-operative bile flow drainage has been achieved by insertion of a EP because these are considered easy to remove and cause less tissue reaction in the bile ducts. However, multiple studies have found the disadvantage with the EP is that it provides poorer bile drainage than the SEMS.

In palliative situations, metal stents have been associated with fewer side-effects in the form of fever relapse of jaundice, etc. These effects are likely due to better bile flow through the stent. It remains unclear if metal stents can provide similar advantages in the curative situation.

Eligibility Criteria:
Inclusion Criteria:

* The primary inclusion criteria are all patients with operable Periampullary cancer and jaundice who have not previously undergone bile flow drainage.

Exclusion Criteria:

* Define as failed ERCP, patients who have previously undergone bile flow drainage or radical surgery is not possible.