cyrilzakka/clinical-trials huggingface dataset:
Faecal Microbiota Transplantation for Liver Cirrhosis

The purpose is to investigate the effect of faecal microbiota transplantation (FMT) on complications, progression, and mortality of patients with liver cirrhosis. Further, the investigators want to examine the impact of FMT on the gut microbiota, gut barrier function, systemic inflammation, and immune function.

Patients with liver disease have a disturbed gut microbiota. This is often associated with disease progression and development of complications, so-called episodes of decompensation. In this trial, we will change the microbiota of these patients by transferring a healthy microbiota through faeces from a healthy donor, a procedure known as faecal microbiota transplantation (FMT). We will examine the effect of FMT on the prognosis and disease progression of the patients. Further, we will examine the mechanistic effects of FMT. We will at random divide 220 patients admitted with decompensation of liver cirrhosis evenly into two groups. One group will receive FMT and the other group will receive placebo. After the treatment, we will follow the patients for one year and examine disease progression as well as changes in their gut microbiota, gut barrier, and immune function.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Liver cirrhosis with Child-Pugh ≤ 12
* Acute decompensation requiring intervention (ascites, gastrointestinal bleeding, infections leading to progressive liver failure, overthepatic encephalopathy, alcoholic hepatitis)

Exclusion Criteria:

* More than one organ failure defined by CLIF-SOFA score
* Untreated malignancy apart from non-melanoma skin cancer
* Untreated viral hepatitis
* HIV
* Inflammatory bowel disease
* Celiac disease
* Clostridioides Difficile infection
* Pregnancy
* Unable to participate based on medical judgement
PF-06741086 Multiple Dose Study in Severe Hemophilia

This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of multiple subcutaneous and/or intravenous doses of PF-06741086 in subjects with severe hemophilia.


Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia A or B (Factor VIII or Factor IX activity ≤ 1%), including patients with inhibitors to Factor VIII or Factor IX
* Episodic (on-demand) treatment regimen prior to screening
* At least 6 acute bleeding episodes during the 6-month period prior to screening

Exclusion Criteria:

* Known coronary artery, thrombotic, or ischemic disease
* Currently receiving treatment for acute bleeding episodes with APCC and cannot substitute treatment with rFVIIa
DTx Algorithms for Personalized Parkinson's Disease Treatment and Medication Plan Optimization

The study is aimed at developing Digital Therapeutics (DTx) algorithms for personalized PD treatment and medication plan optimization, based on Real World Data (RWD) collected from patients via digital mobile app and wearable sensors.

The study design is observational/noninterventional, prospective, single-arm, aimed at collecting data from wearable sensors for validation of symptom detection algorithms, through (1) a supervised in-clinic motor assessment, performed using validated clinical scales (Visit 3, Visit 4), and (2) an unsupervised, home-based, 6-month (Visit 3 to Visit 4) data collection from wearable devices (passive monitoring) for algorithm cross-validation using patient reported outcomes (PROMs) and remote clinical assessments. The devices used in the study will be a commercial smartwatch (Garmin Vivosmart 5) for inertial data collection and a digital application through which subjects will report PROMs via a digital symptom diary. Screening visits (Visit 1 and Visit 2) will be conducted prior to enrollment to verify eligibility criteria through clinical assessments, the subjects' symptom diary, and by assessing adherence to the use of the study tools provided (i.e., mobile application and smartwatch).


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent (IC) obtained.
2. Age \> 18 years.
3. Male or female patients Meeting the MDS clinical diagnostic criteria for Parkinson's Disease (Postuma et al., 2015)
4. At least one motor symptoms OFF-period each day, excluding early morning akinesia.
5. On treatment with Levodopa
6. Stable Levodopa regimen for 4 weeks before Screening Visit;
7. Levodopa Equivalent Daily Dose (LEDD) \> 400 mg, OR Levodopa Intake \> 2 administration/day;
8. The subject is willing and able to attend study procedures and to use wearable and mobile devices.

Exclusion Criteria:

1. Secondary or atypical PD.
2. Cognitive problems which significantly impair his/her ability to give an IC and perform the study tasks.
3. Levodopa Equivalent Daily Dose (LEDD) \> 800 mg, OR Levodopa intake \> 8 administration/day;
4. Any condition that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part in the study.
5. Concomitant participation to clinical trials with investigational medicinal products.
6. Failure to show, in opinion of the investigator, acceptable/appropriate use of wearable and mobile device (e.g. weekly average daily wearable wear time \< 8 hours).

Having an advanced treatment (including Deep Brain Stimulation, Apomorphine, Duodopa), is not an exclusion criterion, as well as the subject decision or capability to attend the exercise and speech training programs within the mobile app.
Study of Chinese Newly Diagnosed Participants With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

Observational medical record review of newly diagnosed CML-CP participants in China


Eligibility Criteria:
Inclusion Criteria:

* Ph+ CML-CP patients who were diagnosed between August 1, 2014 to August 1, 2016
* 18 years or older at time of diagnosis

Exclusion Criteria:

* Participants once enrolled in any interventional clinical trial for CML
* Participants whose records are not available

Other protocol defined inclusion/exclusion criteria could apply
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)

Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.


Eligibility Criteria:
Inclusion Criteria:

* Minimal age of 18 years
* Episode of threatened preterm labour

Exclusion Criteria:

* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
* Spontaneous rupture of membranes at the time of randomization
* Cervical cerclage in situ
* Active vaginal bleeding
* Placenta previa

Sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).
Lung Protection and Pediatric Cardiac Surgery

The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung perfusion is maintained solely by the bronchial arterial system

The study will be performed in the pediatric cardiothoracic unit, pediatric Assiut University Hospital. After obtaining approval from the local ethics committee and written informed parents consent 60 patients will be included in this study according to the following criteria:

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery
* Ventricular septal defect (VSD).
* Atrial septal defect (ASD)

Exclusion Criteria:

* Cyanotic heart disease.
* Patients with preoperative chest problems.
* Patients with known renal or hepatic dysfunctions.
* Planned off-pump cardiac surgery.
* Emergency cardiac surgery.
THC and CBD: a Controlled Human Study Probing a Harm Reduction Strategy

The purpose of this research is to assess the impact of CBD on the effects of THC.

Some evidence indicates that cannabidiol (CBD), a non-intoxicating cannabis component, might mitigate certain effects of THC. This study will examine possible roles for CBD in modulating THC's adverse and analgesic effects.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant and non-lactating females aged 21-55 years
* Report cannabis use 1-7 days per week over the month prior to screening
* Not currently seeking treatment for their cannabis use
* History of inhaled cannabis use
* Have a Body Mass Index from 18.5 - 34 kg/m2
* Able to perform all study procedures
* Must be using a contraceptive (hormonal or barrier methods)

Exclusion Criteria:

* Meeting DSM-V criteria for severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine, mild or moderate CUD
* Evidence of severe psychiatric illness (e.g. mood or anxiety disorder with functional impairment or suicide risk, schizophrenia) judged by the study physician (and PI) to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.
* Report using other illicit drugs in the prior 4 weeks
* Current pain
* Pregnancy
* Currently enrolled in another research protocol
* Not using a contraceptive method (hormonal or barrier methods)
* Insensitivity to the cold water stimulus of the Cold Pressor Test
* Any disorders that might make cannabis administration hazardous as determined by evaluation physician after review of all medical assessments along with medical history.
* Not able to speak and read English
Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

The purpose of this study is to investigate the combination of gemtuzumab ozogamicin, mitoxantrone and etoposide as second line therapy in patients with acute myeloid leukemia.

The combination of mitoxantrone and etoposide is an active regimen in refractory/relapsed AML patients. In order to improve the efficacy of mitoxantrone and etoposide as second line therapy in patients with AML we proposed to conduct a phase I/II clinical trial combining gemtuzumab ozogamicin with mitoxantrone and etoposide. The phase I portion of the trial will determine the maximum tolerated dose of gemtuzumab ozogamicin combined with mitoxantrone and etoposide and the phase II portion of the trial will determine the efficacy and safety of the combined regimen in patients with AML.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and have the ability to provide written consent
* Between 18 and 70 years of age
* Patients with CD33 positive (determined as CD33 expression in ≥ 20% of leukemic blasts) de novo AML that did not respond to first line induction therapy
* ECOG Performance Status of 0-2
* Patients must have the following laboratory values within 48 hours prior to beginning protocol treatment: Serum creatinine ≤ 1.5 mg/ml and calculated creatinine clearance ≥ 50mL/min (using the Cockcroft-Gault equation); AST ≤ 59 IU/L; ALT ≤ 72 IU/L; Total bilirubin ≤ 1.3 mg/ml; Note: Hematologic abnormalities will not be used as a criteria for entry or exclusion.
* Patients must have left ventricular ejection fraction (LVEF) ≥50%
* Females of child-bearing potential must have a negative pregnancy test during screening and all subjects must agree to use an effective method of contraception.

Exclusion Criteria:

* Patients with acute promyelocytic leukemia
* Prior use of mitoxantrone or etoposide or gemtuzumab ozogamicin
* Antecedent hematologic disorder preceding initial presentation of AML or therapy related AML
* History of thromboembolic event within the past 12 months
* Hepatitis B or C or HIV positive serology
* Symptomatic central nervous system (CNS) involvement
* History of congestive heart failure
* Myocardial infarction in the past 6 months
* Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
* History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
* Patient may not be receiving any other anti neoplastic investigational agents
* INR\> 1.5 or patient is receiving systemic anticoagulation (e.g warfarin)
* Patient undergone autologous or allogeneic stem cell transplantation
* Other active malignancies except for non-melanoma skin cancer or cervical intraepithelial neoplasia
* Women who are pregnant or breastfeeding.
A Study in Healthy Men and Women to Test Which Effects Memantine and BI 425809 Have on Each Other

Investigate the effect of steady state exposures of memantine on the steady-state pharmacokinetics of BI 425809 and vice versa in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* BMI of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
* Male subjects, or female subjects who meet any of the following criteria from the first administration of trial medication until 30 days after trial completion:

  * Use of adequate contraception that does not contain hormones, i.e. nonhormonal intrauterine device plus condom
  * Sexually abstinent
  * A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
  * Surgically sterilised (including hysterectomy)
  * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* Further exclusion criteria apply
Evaluation of Safety and Performance of the Orbix Breast Lift System

The study is using a new breast lift system to complement a breast-lift operation.

In general there will be recurrence of breast-ptosis after a correcting operation.

With this device we want to minimize this recurrence and provide an "internal bra".


Eligibility Criteria:
Inclusion Criteria:

1.Female subject between 30-50 years of age 2. Subject is referred for mastopexy(breast lifting)due to one of the following reasons:

* Breast ptosis grade I or II (minimal invasive)
* Breast ptosis grade I to IV (open procedure)
* pseudoptosis following breast reduction surgery 3. subject willing to participate as evidenced by signing the written informed consent 4. Minimal invasive: breast cup size \<C

Exclusion Criteria:

1. Pregnant or lactating women
2. history of surgical procedures involving the ribs and rib cage
3. Osteoporosis
4. breast implants
5. breast carcinoma
6. auto-immune disease -
A Custom-Designed MR Coil for Spine Radiotherapy Treatment Planning

The purpose of this study is to assess the image quality improvement provided by a custom MR spine coil in comparison with the FDA approved coil when used for radiotherapy treatment planning.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers age 18 or older

Exclusion Criteria:

* Anyone who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire
* Volunteers with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
* Female volunteers who are pregnant or nursing
* Volunteers who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety
* Volunteers who are under direct supervision of any investigators on the study will not be eligible to participate
External Validation of Delirium Prediction Models for Intensive Care Patients

Delirium is frequently observed among critically ill patients and is associated with detrimental outcomes. Currently, no evidence-based prevention or treatment exists for delirium, and especially, the inability to identify effective preventive measures of delirium has increased the focus on identifying patients with a high risk of delirium through prediction models. Two prediction models have been developed to estimate the risk of delirium in ICU patients: the prediction model for delirium (PRE-DELIRIC) and the early prediction model for delirium (E-PRE-DELIRIC). These robust and well-calibrated prediction models have the potential of assisting in identifying patients with the highest risk for delirium and thereby to focusing preventive strategies on the most vulnerable group. However further validation is needed in a Danish population.

Adult ICU patients admitted to the participating ICUs in the Region Zealand are included according to eligibility.

Eligible patients will be assessed with E-PREDELIRIC at admission to the ICU and PREDELIRIC 24h after admission to the ICU. Patients will be screened twice daily with CAM-ICU until ICU discharge, death, transferal to non-participating ICU or for a maximum observation period of 14 days.

Central screening via EPIC PDM and registration in central database (REDCap, ZUH) by the principal investigator.

The following are registered: Age, sex, history of cognitive impairment, history of alcohol abuse, admission category, urgent admission, mean arterial blood pressure at the time of ICU admission, use of corticosteroids, respiratory failure, Blood Urea Nitrogen/Carbamide, APACHE-II score, administered morphine does, use of sedatives, metabolic acidosis, coma, presence of infection, delirium status by CAM-ICU, time of ventilation, length of ICU and hospital stay, mortality.

Eligibility Criteria:
Inclusion Criteria:

* Acute admission to an ICU AND
* Age \> 18 of years

Exclusion Criteria:

* Total admittance to the ICU less than 24 hours
* Delirium assessment nonapplicable (hearing or visual disabilities, language barriers, or mentally incompetent
A Single Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of MYK-491

Up to 72 healthy volunteers will be given a single dose of MYK-491 or placebo and be monitored for safety and tolerability over a 7 day period.

Up to 72 healthy volunteers will be given a single dose of MYK-491 or placebo and be monitored for safety and tolerability over a 7 day period. After the 28 day screening period, the eligible subject will be admitted to the clinical site and will receive a single dose of study drug or placebo. Subjects will be confined to the clinical site for five days (Day -1 to Day 4) and will return to the clinic on Day 7 for a safety follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Weight between 60 and 90 kg inclusive
* Resting heart rate of \< 80 beats per minute
* Documented LVEF greater than or equal to 55% during Screening
* Normal electrocardiogram (ECG) at Screening
* Normal acoustic windows on transthoracic echocardiograms at Screening
* All safety laboratory parameters within normal limits at Screening
* History or evidence of another clinically significant disorder, in the opinion of the investigator.

Exclusion Criteria:

* Active infection
* History of coronary artery disease
* History of malignancy with the exception of in situ cervical cancer more than 5 years prior to Screening or surgically-excised non-melanomatous skin cancers more than 2 years prior to Screening
* Positive serology tests at screening
* Current use of tobacco or nicotine-containing products exceeding 10 per day.
Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination

HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true among traditionally underserved adolescents. Few parent-targeted interventions have focused on the parental decision-making process. Self-persuasion, generating one's own arguments for engaging in a behavior, may be an effective means to influence parents' motivation to vaccinate their children. In a three-phase study, investigators are using quantitative and qualitative research methods to develop and refine a tablet-based self-persuasion intervention for parents who are undecided about the HPV vaccine. This clinical trial submission focuses on the second phase of the study. The results of the second phase will inform the third phase of the trial (also registered in clinical trials).

Despite the fact that HPV vaccination is recommended for male and female adolescents, HPV vaccine 3 dose coverage among adolescents is poor (38% for girls, 14% for boys). HPV-related cancers are a significant burden on the US healthcare system and could be prevented through adolescent vaccination. Rates of vaccination are suboptimal among underserved populations (uninsured, low-income, racial and ethnic minorities) often seen in safety-net clinics. Few interventions have been designed that target decision-making among parents of unvaccinated adolescents. Self-persuasion, generating of one's own arguments for a health behavior, may be an effective means of influencing HPV vaccination behaviors among undecided or ambivalent parents. Through three stages, investigators will identify and develop a self-persuasion intervention strategy to promote adolescent HPV vaccination in safety-net clinics. The current trial, Stage 2, is a four-arm randomized controlled trial (RCT), using a 2x2 factorial design, in which investigators will assign participants to one of four self-persuasion intervention conditions that vary by cognitive processing level (verbalize vs. listen to arguments) and choice of argument topics (parents choose vs. are assigned topics) to identify which intervention condition is optimal. Conducted in a laboratory setting, investigators will identify and select the optimal intervention condition through quantitative analysis of the effects on parents' vaccination intentions and qualitatively by exploring parental experiences with the self-persuasion tasks.

Eligibility Criteria:
Inclusion Criteria:

* Undecided parents (18 years and older) whose children are 11-17 year old patients who have not begun the HPV vaccine series.

Exclusion Criteria:

* Parents whose child is a pregnant adolescent
* Lack telephone access
* Having impairing hearing or speech
* Participants will be excluded from participation in future stages