cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults

This is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of MTP-131.

The primary objective of the study is to evaluate the safety and tolerability of MTP-131 in healthy volunteers following a single intravenous infusion. The secondary objective is to evaluate the pharmacokinetics of MTP-131. This is a double-blind, placebo-controlled, randomized trial. A total of 40 eligible subjects will be enrolled and randomized in a 3:1 active to placebo ratio for a total of 5 treatment groups of 8 volunteers. As far as is logistically possible, each treatment group will have similar numbers of male and female volunteers. After the last subject for each cohort has completed the day 3 clinical assessment and no stopping rules have been met according to Safety Review Board decision, the next cohort will commence.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males or females age ≥18 years of age with signed informed consent.
* Women who are not post-menopausal or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment and who agree to use effective contraception for 30 days following the study.

Exclusion Criteria:

* Clinically significant laboratory abnormalities,
* Clinically significant abnormalities on physical examination,
* BMI of less than 18 kg/m2 or greater than 32 kg/m2,
* Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems,
* History of seizures or epilepsy,
* History of serious mental illness,
* Participant in unrelated research involving investigational product within 30 days before planned date of drug administration,
* Positive serology for HIV 1, HIV 2, HBsAg, or HCV,
* Fever greater than 37.5°C at the time of planned dosing,
* Suspicion of or recent history of alcohol or substance abuse,
* Donated blood or blood products within the past 30 days,
* Women who are pregnant or breastfeeding,
* Employee or family member of the investigational site, and
* Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products,
* Subjects who are either unwilling to agree to refrain from use or found to be using:

  1. Alcohol, caffeine, xanthine-containing food or beverages, nicotine products and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement period
  2. Prescription medications from 14 days prior to and 7 days post treatment
  3. Oral contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to and 30 days post treatment
PURI-PRO - Symptoms Impact and eHealth Intervention for Menopausal Women With Urinary Incontinence

Urinary Incontinence (UI) is a public health problem that disrupts the Quality of Life, Productivity, Social Isolation and Sexual Function; its prevalence in peri- and postmenopausal women is around 30-40%. UI remains underreported and undertreated. Previous eHealth interventions have been efficacious with women.

Thus, PURI-PRO (Portuguese Urinary Incontinence Project) (FCT Grant 2020.05710.BD) entailed a low-cost 8-week eHealth cognitive-behavioural multidisciplinary intervention aimed at reducing UI symptoms' severity through Pelvic Floor Muscle Training, development of healthy bladder habits, and promotion of adherence to exercises, realistic UI-beliefs, and functional coping strategies.

Urinary incontinence symptom severity, frequency and its impact on quality of life, beliefs and strategies regarding urinary incontinence, self-esteem, social isolation, and adherence to pelvic floor muscle excercises were evaluated.

PURI-PRO's intervention followed an experimental design (randomised controlled trial) involving UI intervention (Experimental Group-EG) vs. Health Literacy single-leaflet (Control Group-CG), both delivered through the internet (eHealth). The study was comparative, since the sample was distributed in two groups (EG vs CG) through randomised distribution, and longitudinal, since all the outcome measures were evaluated at four different times.

Eligibility Criteria:
Inclusion Criteria:

* Age (40-65 years);
* Sex (women);
* The presence of UI (positive response to a question about experiencing involuntary urine loss during intra-abdominal pressure increment and/or when feeling an incontrollable urge to urinate, occasionally or frequently);
* Internet access.

Exclusion Criteria:

* Pregnancy or delivery in the past 6 months;
* Previous UI-related surgery;
* History of pelvic prolapse:
* Known malignancy in the lower abdomen;
* Neurological disease that could affect bladder control;
* Substance use disorder.
A Study of Epoetin Beta (NeoRecormon) in Anemic Participants With Diabetes and Chronic Renal Failure Who Are Not on Dialysis

This study will evaluate the effect of epoetin beta (NeoRecormon) on correction of anemia and quality of life in participants with diabetes and chronic renal failure and who are not receiving dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or 2 diabetes
* Chronic renal failure (stage 2 to stage 5) defined by Glomerular Filtration Rate (GFR) less than (\<) 90 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2)
* Anemia related to chronic kidney disease and requiring treatment with erythropoiesis-stimulating agent (ESA) (2 values of hemoglobin less than or equal to 11 gram per deciliter \[g/dL\] during the 3 months prior to inclusion), and hemoglobin greater than 8 g/dL

Exclusion Criteria:

* Anemia due to a non-renal cause
* Poorly controlled hypertension
* Treatment with an erythropoiesis stimulating agent (ESA) within 3 months prior to the study
* Planned dialysis in next 3 months or organ transplant
* History of cancer except for basal cell cancer and cervical cancer in situ
Post-partum Depression, Breastfeeding Adherence and Fear in COVID-19

This study aims to explore whether quarantine measures, social distancing and hospital containment policies among women giving birth during the COVID-19 pandemic enhanced psycho-emotional distress in the immediate postpartum period. The investigators tested for depression using the Edinburgh Postnatal Depression Scale (EPDS) in the first 6 postpartum months, and then used the Fear of COVID-19 Scale, measuring also the adherence and practices of breastfeeding according to WHO.


Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥18 years
* Women who delivered singletons at term in the last 6 months during the COVID-19 pandemic

Exclusion Criteria:

* Women who delivered two or more products
* Women who delivered singletons at term past the last 6 months during the COVID-19 pandemic
* Women who delivered singletons pre or post-term in the last 6 months during the COVID-19 pandemic
Artificial Intelligence Evaluation of Fillings

The goal of this Non-Interventional Clinical Research is to detect the prevalence and distribution of filling and overhanging filling without the need for additional bitewing radiographs using panoramic images, based on a deep CNN (Convolutional Neural Network) architecture trained through supervised learning.

In this study, retrospectively obtained radiographs were used in the development of artificial intelligence models for relevant situations. These datasets were obtained from the images of the patients who applied to ESOGU (Eskişehir Osmangazi University) Dentistry Faculty, Dentomaxillofacial Radiology clinic for various dental purposes. Eskisehir Osmangazi University Non-Interventional Clinical Research Ethics Board (decision date and decision number: 04.10.2022/22) approved the study protocol. The principles of the Helsinki Declaration were followed in the study.


Eligibility Criteria:
Inclusion Criteria:

* Images of individuals in the permanent dentition period
* Artifact-free images in the examination region
* Individuals with a history of restorative dental treatment

Exclusion Criteria:

* Images of individuals in mixed dentition
* Radiographic images obtained by incorrect positioning of the patient or containing artifacts
Outcomes of Complete Versus Partial Preservation of the Sub-valvular Apparatus in Cases of Mitral Valve Replacement

The purpose of this study is to evaluate the outcomes of complete (preservation of both anterior and posterior leaflets) versus partial (preservation of posterior leaflet only) preservation of subvalvular apparatus in cases of mitral valve replacement

After mitral valve replacement (MVR), sudden increases in afterload and disruption of the annular-chordal-papillary-left-ventricular wall causes left ventricular (LV) dysfunction in the early postoperative period.

patients with LV dysfunction after MVR have a significantly lower 8-year survival rate compares with patients who did not have LV dysfunction Papillary muscles play an important role in the left ventricular contraction by drawing the mitral ring toward the apex, thereby causing shortening of the long axis and spherity of the chamber contribute for better ejection of blood.

preservation of papillary muscles and chordae tendineae in MVR reduces postoperative mortality, low cardiac output syndrome and improves haemodynamic function.

Partial preservation of the mitral apparatus through preservation of the posterior leaflet (MVR-P) has been proven to significantly reduce perioperative mortality.

The importance of complete preservation of the mitral apparatus remains controversial, but it is hypothesized that complete preservation with preservation of both the anterior and posterior leaflets may contribute to superior postoperative hemodynamic function as compared to partial preservation.

Due to the increased technical complexity of preserving both leaflets, concerns about longer bypass and cross-clamp times, the need to undersize prostheses, and the possibility of left ventricular outflow tract (LVOT) obstruction, the majority of cardiac surgeons currently prefer to preserve the posterior leaflet alone.

Eligibility Criteria:
Inclusion Criteria:

* - Age between 18 and 60 years
* Rheumatic mitral disease indicated for mitral valve replacement
* Concomitant other valve disease

Exclusion Criteria:

* - Patients who have undergone previous mitral valve surgery or other heart surgery.
* Patients with ischemic mitral disease.
* emergency operation.
* patients with significant comorbidities (severe pulmonary disease or end stage renal disease).
Prebiotic Supplementation and Intestinal Barrier Function in Elderly: a RCT

The investigators aim was to assess whether 6 weeks of oral intake of the wheat-derived prebiotic fiber arabinoxylan or oat-derived beta-glucan could improve intestinal barrier function against drug-induced barrier disruption in a general population of elderly people, in a randomized double blinded placebo-controlled clinical trial.

The study consisted of a 9 week clinical trial to which the study participants orally ingested two different prebiotic compounds/one placebo for a total of 6 weeks.

The primary outcome was intestinal permeability which was measured before/after indomethacin intake before starting with the prebiotic supplementation and repeated 6 weeks afterwards.

Indomethacin is an NSAID known to artificially increase the intestinal permeability. The prebiotic fibers arabinoxylan and oat-derived beta-glucan have not been investigated for their effect on intestinal permeability in older adults.

Intestinal permeability was investigated using the multi-sugar permeability test. Participants ingested a water solution containing 5 sugar probes that are taken up in different parts of the gut. These sugars are later recovered in the urine at two different time points, reflecting gastroduodenal, small intestinal and colonic permeability.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed by study participant
* Age ≥ 55 years
* Mentally and physically fit to complete questionnaires during the study period

Exclusion Criteria:

* Known or genic gastrointestinal disease, with strictures, malignance's and ischemia.
* Inflammatory bowel diseases (IBD)
* Participation in other clinical trials in the past three months.
* Intake of medications know to change the inflammatory status (i.e proton pump inhibitors, antibiotic, anti-inflammatory medication (including NSAIDs)
Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy

This study will evaluate the pharmacokinetics of brimonidine following a single intravitreal administration of the 200 ug or 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery System in patients 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Plan on having a pars plana vitrectomy for repair of a posterior segment condition (eg, epiretinal membrane, macular hole, vitreomacular traction)
* Visual acuity in the non-study eye better than 20/200

Exclusion Criteria:

* History of pars plana vitrectomy or retinal detachment surgery in the study eye
* Surgery or laser treatment in the study eye within 3 months
* Use of brimonidine, apraclonidine or other topical alpha-2-agonist in either eye within 2 weeks
* Intraocular infection or inflammation
A Study of Single Dose of LP-003 in Healthy Adult Subjects

The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or females aged ≥18 and ≤ 50 years.
2. Male subjects must weigh ≥50 kg, and female subjects must weigh ≥45 kg, with a BMI between 19.0 and 28.0 kg/m² (inclusive).
3. Male subjects and their partners or female subjects must agree to use one or more non-pharmaceutical contraceptive methods (such as total abstinence, condoms, Iuds, partner ligation, etc.) during the trial period and for 6 months after the trial, and do not plan to donate sperm or eggs.
4. The subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily participate in the experiment and sign the informed consent.
5. The subjects were able to communicate well with the researchers and complete the study according to the protocol.

Exclusion Criteria:

1. People who are allergic to the experimental drug and any of its excipients, have a history of allergy to monoclonal antibodies, and are allergic to multiple drugs and food.
2. Patients who have been or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatric and metabolic abnormalities, or any other diseases that can interfere with the test results.
3. Patients who had undergone surgery within 3 months before the trial that the researchers judged would affect drug absorption, distribution, metabolism, and excretion, or had surgery within 4 weeks prior to the trial, or planned to have surgery during the study period.
4. Any history of infection within 14 days prior to administration.
5. A person who is currently infected with parasites or has traveled to an endemic area within the last 3 months or 24 weeks prior to administration.
6. Pregnant and lactating women.
7. Hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, treponema pallidum antibodies A positive person.
8. Patients who have received any biological agent (including antibodies or derivatives such as omazumab) within 16 weeks prior to administration (or 5 half-lives, selecting the longer time period).
9. Participants who had participated in other clinical trials within 3 months prior to screening.
10. The investigator deems any condition unsuitable for study participation.
Construction and Validation of a Diagnostic Model for Predicting Molecular Residual Disease and Recurrence of Cervical Cancer Based on Circulating Tumor HPV

Systematic evaluation of the value of molecular residual lesions of cervical cancer based on circulating tumor HPV in the prognostic evaluation and recurrence monitoring of cervical cancer patients.

Cervical cancer has a very clear etiology, with the vast majority of cases being caused by persistent and repeated infections with high-risk HPV. In the carcinogenic mechanism of cervical cancer, there are large amounts of HR-HPV integrated into the human genome in cancer cells; these HR-HPV can be released into the bloodstream in the form of ctHPV, and most patients with stages I-IV of cervical cancer can have detectable ctHPV in their blood. Among them, the detection rate in the blood of late-stage patients ranges from 63.3% to 100%. Several studies have demonstrated that ctHPV may serve as a marker for monitoring recurrent tumor molecular residual lesions, which could be of significant importance for prognostic evaluation and monitoring whether the disease has recurred. In this study, we will systematically evaluate the value of molecular residual lesions of cervical cancer based on circulating tumor HPV in the prognostic evaluation and recurrence monitoring of cervical cancer patients

Eligibility Criteria:
Inclusion Criteria:

1. Women, aged between 18 and 75 years, can receive standard treatment, including patients who only receive surgery, and patients who receive radiotherapy and chemotherapy after surgery.
2. Cervical cancer caused by HPV16 or HPV18 infection diagnosed by molecular biology or pathological tissue (p16), with pathological stage of IB1 to IV.

   -

Exclusion Criteria:

1. Patients with other malignancies
2. Patients with any uncontrolled systemic disease, including active infection, uncontrolled hypertension, diabetes mellitus, unstable angina and congestive heart failure, myocardial infarction (1 year) before starting treatment, severe arrhythmia requiring medical treatment, coagulation abnormalities, liver or kidney or metabolic disease
3. Cervical cancer patients who had undergone LEEP knife or conization in primary hospitals
4. Cervical cancer patients whose peripheral blood was negative for ctHPV at baseline. Here, ctHPV negative refers to patients who are both negative for ddPCR and NGS
Prehabilitation in Prostate Cancer Patients, TelePrehabTrial

Localized prostate cancer is commonly treated with radical prostatectomy (RP). Following surgery adverse effects such as urinary incontinence, erectile dysfunction associated with decreased quality of life and decreased physical function are common.

Traditionally, interventions to reduce these adverse effects are introduced postoperatively. However, a growing body of literature shows the benefit of interventions prior to surgery to enhance treatment success, known as prehabilitation.

Hence, the main purpose of this study is to develop and investigate the feasibility of prehabilitation using telehealth, to implement several interventions prior to elective RP.


Eligibility Criteria:
Inclusion Criteria:

* Male \> 18 years
* Diagnosed with prostate cancer and referred to robot assisted nerve sparring RP
* Adequacy in written and spoken Danish
* Cognitively well-functioning
* Able to understand the study procedures and willing to provide signed informed consent

Exclusion Criteria:

* Severe comorbidities that would prevent the patient from exercising, e.g. recent fractures, severe heart disease or neurological disorders.
* No possibility to use a smartphone or tablet.
Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)

Study 0038 compares the safety and effectiveness of an investigational drug, TD-5108 with placebo (a sugar pill) for the treatment of chronic constipation.


Eligibility Criteria:
Inclusion Criteria:

* Meet ROME III Criteria

Exclusion Criteria:

* Constipation caused by:colonic etiology, pelvic floor dysfunction, metabolic disturbances, neurologic disturbances,concomitant medications affecting bowel function
* Chronic treatment with anticholinergics, narcotic analgesics
* Irritable Bowel Syndrome
Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants

The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect), parallel-group, multicenter study of the effects of canagliflozin and phentermine co-administration in non-diabetic overweight or obese participants. The study will be conducted for about 33 weeks, approximately 344 participants will be randomly assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo. All participants will be also provided with diet and exercise counseling for weight loss (standardized non-pharmacological therapy).

Eligibility Criteria:
Inclusion Criteria:

* Must have BMI \>=30 kg/m2 and \<50 kg/m2 at screening or BMI \>=27 kg/m2 and \<50 kg/m2 at screening in the presence of a comorbidity of hypertension and/or dyslipidemia
* Must have stable weight, ie, change of \< =5% in the 3 months before screening
* Must agree to utilize a highly effective method of birth control

Exclusion Criteria:

* An established diagnosis of diabetes mellitus
* Has a history of obesity with a known secondary cause (eg, Cushing's disease/syndrome)
* Has a history of hereditary glucose-galactose malabsorption or primary renal glycosuria
* Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 12 weeks before screening
* Has an Glycated hemoglobin (HBA1c) greater than or equal (\>=) to 65 percent
* An average of 3 seated blood pressure (BP) readings of systolic BP \>= 160 mm Hg and/or Diastolic BP \>= 100 millimeters of mercury at screening