cyrilzakka/clinical-trials huggingface dataset:
Regulation of Mucosal Healing in Inflammatory Bowel Disease

The objective of the current study is to compare non-healing colonic ulcers in patients with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients will be biopsied at baseline and again at a follow-up visit in a "biopsy of the biopsy" approach. These biopsies will be used to reveal patterns about gene expression and mitochondrial function during ulcer healing.

Induction of mucosal healing in inflammatory bowel disease (IBD) is associated with reduced hospitalizations, surgeries, and reduced cancer risk. However, previous studies have shown that 54-69% of ulcerative colitis (UC) patients fail to heal ulcers after several weeks of treatment, and roughly half do not maintain remission at one year. The single most important factor in preventing severe medical consequences, like colon removal surgery or cancer, is treatment to completely heal the top layer of the intestine as quickly as possible. Healing is a complex process and the dysfunction observed in colitis can only be fully understood by comparison to healing in non-IBD patients.

This is a prospective trial involving three groups of patients: 1) IBD patients with active disease, newly treated with anti-TNF therapy (biologic failure or naïve); 2) non-IBD patients with rheumatoid/psoriatic arthritis who are receiving anti-TNF therapy, and 3) healthy control patients. Biopsies will be collected at baseline during standard of care endoscopy and at a follow-up research endoscopy.

This study will probe mechanisms of ulcer healing by analyzing gene expression patterns and mitochondrial function.

Eligibility Criteria:
Inclusion Criteria (Group 1):

* Diagnosed ulcerative colitis or Crohn's disease
* Biologic failure or naive to biologic treatment
* Eligible to be treated with anti-TNF therapy

Inclusion Criteria (Group 2):

* Diagnosed rheumatoid or psoriatic arthritis
* Receiving anti-TNF antibody therapy at the time of enrollment

Inclusion Criteria (Group 3):

* Endoscopically unremarkable colonic mucosa
* Absence of inflammatory bowel disease

Exclusion Criteria:

* Classified in an anesthesia risk group, ASA Class =4
* History of bleeding diathesis or coagulopathy
* Stroke or transient neurological attack with the last 6 months
* Pregnant
* Receiving anticoagulants or anti-platelet medications other than low-dose aspirin
* Receiving steroid therapy or metformin
* HIV positive
* Incarceration
* History of total proctocolectomy
* History of system chemotherapy within 18 months
* Uncontrolled intercurrent illness
Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial of LMTM continued access to therapy and to evaluate the long-term safety of LMTM.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with all cause dementia and probable Alzheimer's disease at enrollment and who completed participation in one of the following three TauRx studies (inclusive of the 4-week post-treatment follow-up visit): TRx-237-005, TRx-237-008, or TRx-237-015.
* Subjects with a diagnosis of probable bvFTD at enrollment and who completed participation in TauRx study TRx-237-007 through Visit 9 (Week 52).
* Females, if of child-bearing potential, must practice true abstinence or continue to use adequate contraception and agree to maintain this throughout the study
* Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law and ethics approval is/are able to read, understand, and provide written informed consent
* Has an identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥1 hour/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
* Able to comply with the study procedures

Exclusion Criteria:

* History of swallowing difficulties
* Pregnant or breastfeeding
* Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging abnormality (in originating study) or emergent intercurrent illness that, in the judgment of the principal investigator, could result in the risk of participation outweighing the potential benefit
* Current participation in, or intent to enroll in, another clinical trial of a drug, biologic, device, or medical food
* In Germany, subjects mandated to reside in a continuous care or assisted living facility or those whose willingness to participate in the clinical trial may be unduly influenced
Antiproteinuric Efficacy of Losartan Potassium in Patients With Non-Diabetic Proteinuric Renal Diseases (0954-213)

Antiproteinuric Efficacy of Losartan Potassium in Patients with Non-Diabetic Proteinuric Renal Diseases.


Eligibility Criteria:
Inclusion Criteria:

* Males or females at least 18 years of age with non-diabetic proteinuric renal diseases
A Single Ascending Dose Study To Evaluate Safety And Pharmacokinetics Of Compound PF-06648671 In Healthy Subjects

This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending doses of PF-06648671 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential
* BMI of 17.5 to 30.5 kg/m2 and a total body weight \>50 kg (110 lbs)
* Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drg allergies, but excluding untreated asymptomatic, seasonal allergies at the time of dosing);
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer)
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.
Helping Moms Quit Pilot Trial

The objective of this study is to test the feasibility and preliminary effectiveness of a tailored text message program to support smoking abstinence among postpartum women who smoke or recently quit.

This pilot trial will evaluate a text message intervention (Moms Quit) to be initiated with postpartum women within one month of delivery. Moms Quit is a tailored program to support smoking abstinence among new mothers who are either current smokers or quit during their most recent pregnancy. Investigators will randomize 30 postpartum women, stratified by recent/current smoking status, into Moms Quit versus vs. CONTROL. Investigators hypothesize that participants receiving Moms Quit will have, on average, a significantly longer period of self-reported prolonged abstinence compared to CONTROL.

Eligibility Criteria:
Inclusion Criteria:

* Less than one month postpartum
* Live delivery
* Smoked at least 100 cigarettes/lifetime
* Smoked anytime during their most recent pregnancy
* English-speaking
* Own a mobile phone
* Provide an email address
* Willing to receive intervention-related texts
* Willing to complete surveys
* Willing to provide a saliva sample at the end of the study

Exclusion Criteria:

* Women whose pregnancy did not result in live birth
* On a 7-point scale, participant indicates that they are not interested in quitting or staying quit in the next 6 months (Not at all = 1).
Pain in Adults With Autism Spectrum Disorder

Pain insensibility is often described in people with autism. The aim of this study is to test the pain perception in adults with autistic spectrum disorder without intellectual disability. An experimental model of pain is used to measure endogenous modulation systems. Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms. Salivary cortisol and automatic nervous system (heart rate and blood pressure with an electrocardiogram (Brest :system dantec keypoint natus G3 ; Paris: nexfin HD®) are also tested and behavioral response to thermal stimulation assessed by an inspired behavior scale.

Adults with autism without intellectual disability (IQ \> 85) are matched with members of siblings and control group (sex and chronological age).

Pain reactivity (Visual analog scale,endogenous modulation systems, salivary cortisol, automatic nervous system and behavioral responses to thermal stimulation assessed by an inspired behavior scale.) in adult with autism is tested using an experimental model of pain. Excitatory and inhibitory modulation systems were elicited using a temporal summation test administered before and after activation of the Diffuse Noxious Inhibitory Control (DNIC) by means of a cold-pressor test.

Demographic and clinical data are also collected (sensory profile, sleep disorders and depression inventory).

Eligibility Criteria:
Non-specific inclusion criteria:

* intellectual quotient \>85
* consent form signed

Inclusion Criteria autism group :

* autism diagnosis (CIM 10) from multidisciplinary evaluation (ADI-r, ADOS)
* sibling without autism or developmental disorder

Non-specific Exclusion Criteria:

* chronic pain
* pregnancy, breast feeding
* consent form no signed

Exclusion criteria sibling and witness groups:

- diagnosis of autism or developmental disorder
Risk Stratification With Chest CT to Rule-out Suspected SARS-CoV-2 Infections

The study objective is to investigate the diagnostic value and consistency of chest CT as compared with comparison to RT-PCR assay in COVID-19 in patients which were stratified for hospital admission.

To prevent spreading of the new coronavirus (SARS-CoV-2) from patients who are infected but in whom infection was not detected by means of Reverse transcription polymerase chain reaction (RT-PCR) and who are to be admitted to ordinary wards of hospitals, we aimed to determine validity of exclusion of pneumonia immediately before admission by means of chest computed tomography.

Patients admitted to the emergency department of the university hospital Jena with Covid-19 symptoms (temperature \> 37.5°C; respiratory and/or gastrointestinal symptoms) whose RT-PCR test resulted negative, undergo a chest CT scan. Those patients without pulmonary infiltrates can be safely ruled out for Covid-19. Thus, CT has perfect selectivity evidence regarding pulmonary infiltrates; it has limited selectivity concerning the pathogenesis of the infiltration.

The study objective is to investigate the diagnostic value and consistency of chest CT as compared with comparison to RT-PCR assay in COVID-19 in patients which were stratified for hospital admission.

The hypothesis is that chest CT has the greatest clinical evidence (no detection of lung infiltration) when the RT-PCT is tested negative. We assume that chest CT has a high sensitivity for diagnosis of respiratory dominant COVID-19. A pulmonary COVID-19 in epidemic areas can be best ruled out when chest CT is negative for the presence of infiltrations of the lung parenchyma. This is described by the SNOUT principle which is an acronym for 'Sensitive test when Negative rules OUT the disease' under the condition of a low pretest probability.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Provided written informed consent
* Intended hospital admission for any reason
* Symptoms that suggest infection with SARS-CoV-2
* Participant agrees to rt PCR and antibody test (SARS-CoV-2)

Exclusion Criteria:

* \< 18 years
* Pregnancy cannot be excluded
Surgical Treatment of Injuries and Consequences of the Acetabulum

The aim of the program is to develop technologies for the diagnosis and treatment of injuries and consequences of the pelvis.

Purpose: to improve the technique of surgical treatment of acetabular fractures.

Tasks: Implementation of low-traumatic access to the acetabulum; introduction of a new implant for osteosynthesis of complex acetabular fractures into clinical practice; мathematical modeling of fixation of the acetabulum with a new implant; рublication of the results of the work carried out The relevance of the use of new implants in orthopedics is due to the problem of adaptation of implants in the body, especially with poor quality of bone tissue. Currently, work is underway to improve the materials and shapes of implants, new alloys are being studied, polymer implants are being introduced, but the problem of their integration into bones remains. A promising direction in orthopedics is the creation of implants as close as possible in their morphological shape and elasto-strength properties to human bone. But the creation of an absolute copy of the bone structure from a metal alloy leads to a weakening of its strength and loss of fixation stability, and subsequent lysis of the adjacent bone tissue.

All this indicates the need for further search for new, perhaps more promising and effective ways to solve this problem.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years of age
* patients with acetabular fractures undergoing surgery
* acetabular fractures according to the classification of Judet and Letournel

Exclusion Criteria:

* patients under 18 years of age
* posterior wall fracture according to the classification of Judet and Letournel
First in Human Single Ascending Dose Study of MOR107

This is the first in human study of MOR107. It is a 2 part, single centre, double-blind, randomised, placebo-controlled study in healthy male subjects. Part 1 is a single ascending dose study, and Part 2 is a parallel group, dose range finding study in healthy male subjects on a low sodium diet.

MOR107 is an angiotensin 2 receptor (AT2R) agonist with the potential to treat a wide range of diseases through activation of the protective arm of the renin-angiotensin system.

In this study MOR107 will be administered to humans for the first time.

The study will enroll healthy male subjects and is split into two sequential parts, both of which have a single centre, double-blind, randomised, placebo-controlled design.

Part 1 will evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of MOR107.

Part 2 will evaluate the pharmacodynamics, safety, tolerability and PK of three different doses of MOR107 in healthy male subjects who will be fed a low sodium diet in order to increase AT2R expression.

Eligibility Criteria:
Key Inclusion Criteria:

1. Healthy males
2. Age 18 to 45 years of age
3. Body mass index of 18.0 to 32.0 kg/m2
4. For Part 2, subjects must have at least a 25% reduction in 24 hour urinary sodium excretion on Day -2 compared with admission

Key Exclusion Criteria:

1. Subjects who have received any IMP in a clinical research study within the previous three months
2. Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
3. Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening/admission
4. Current smokers of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months
5. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
6. Positive drugs of abuse test result
7. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
8. History of psychiatric disorder, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
9. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be evaluated in adult males with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet the following ADHD diagnostic and inclusion criteria:
* Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for current ADHD subtypes (ADHD combined type, ADHD predominately inattentive type, ADHD predominately hyperactive-impulsive type) as assessed by the clinical interview and confirmed by Adult Attention-Deficit/Hyperactivity Disorder Clinical Diagnostic Scale (ACDS V1.2).
* Subjects must have a total score of 24 or greater on the AISRS at both the Screening and Baseline Visits AND the Baseline Visit AISRS scores must not vary by more than 20% from Screening.
* Subjects are required to have CGI-S score ≥4 (moderate) at both the Screening and Baseline Visits. Subjects should have at least moderate severity for ADHD symptoms.
* For women of childbearing potential, documentation of a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0. All female subjects of childbearing potential must be using a highly effective method of birth control during the study and for at least 1 month after completion of study drug dosing.
* A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \<1% per year) when used consistently and correctly, such as condom + diaphragm, condom + spermicide, diaphragm + spermicide, or intrauterine device \[IUD\] with documented failure rate of \<1% per year, or oral/injectable/implanted hormonal contraceptives used in combination with a barrier method.
* Women are considered to be not of childbearing potential if they have had a total hysterectomy or bilateral tubal ligation (documentation for either must be provided before enrollment) or are at least 2 years postmenopausal. Female subjects cannot be breast-feeding.

Exclusion Criteria:

Any current psychiatric disorder other than ADHD as defined in DSM-IV-TR as assessed by Mini International Neuropsychiatric Interview (MINI). Subjects with dysthymia that does not require pharmacological treatment will not be excluded.

* MADRS total score \>15.
* A diagnosis of ADHD NOS.
* Any diagnosis of lifetime bipolar disorder or psychotic disorder
* A current diagnosis of any severe comorbid Axis II disorder
* Any history of mental retardation, organic mental disorders due to general medical condition or pervasive developmental disorder as defined by DSM-IV-TR.-
Chronic Bronchiolitis or Resistant Asthma?

Chronic Bronchiolitis or Resistant Asthma? Testing a way to diagnosis and treatment


Eligibility Criteria:
Inclusion Criteria:

* Difficult asthma

Exclusion Criteria:

* Patients with potential allergic bronchopulmonary aspergillosis i.e. with peripheral blood eosinophilia, sputum eosinophilia, or any sputum production and bronchiectasis
* A history of smoking
* Significant occupational or environmental exposures
* Evidence on emphysema on chest high resolution computed tomography (HRCT) scan
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease

To establish the efficacy of 40 mg/day doses of istradefylline for the change in Unified Parkinson's Disease Rating Scale (UPDRS) part-III (Motor examination) score in patients with Parkinson's disease (PD).

To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD). Patients who meet entry criteria will be randomly assigned to receive study drug in 1 of 2 arms: Condition A (doses of 40mg/d istradefylline) in Period 1 followed by Condition B (matching placebo) in Period 2 (putting 4 weeks interval phase between two periods ) or Condition B in Period 1 followed by Condition A in Period 2(putting 4 weeks interval phase between two periods ). Patients will be participated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

Eligibility Criteria:
Inclusion Criteria:

1. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
2. PD stages 1-3 for Modified Hoehn and Yahr Scale.
3. Be at least 30 years of age.

Exclusion Criteria:

1. Neurosurgical treatment for PD.
2. History of psychosis.
3. Diagnosis of cancer within 5 years.
4. Diagnosis of clinically significant illness of any organ system.
5. Mini-mental status examination score of 25 or less.
6. Taking any excluded medications.
7. History of drug or alcohol abuse or dependence within the past two years.
8. History of seizures or neurological malignant syndrome.
9. Clinical depression.
10. Pregnant or lactating females.
Pregnancy Prediction Using Anti-Müllerian Hormone in Intrauterine Insemination Cycles

The goal of this study is to compare the cumulative pregnancy rates after 4 artificial inseminations with donor (IAD) in non-sterile women with plasma AMH levels \> and \< 1.1 ng/mL.


Eligibility Criteria:
Inclusion Criteria:

* IUI cycles with sperm donors either due to severe oligoasthenoteratozoospermia in the partner (defined as a motile sperm count (MSC) \< 5 million in the ejaculate) or for social reasons, with up to 4 attempts accounted for.

Exclusion Criteria:

* BMI \>30
* Infertility due to bilateral tubal factor
* Endometriosis grade II-IV.
A Study of Real-World Use of Ixazomib Citrate in People With Multiple Myeloma (MM)

In this study, people with MM will be treated with ixazomib citrate according to their clinic's standard practice. The main aim of the study is to check for side effects from ixazomib citrate.

This is a non-interventional, prospective, observational post-marketing surveillance study of ixazomib citrate in participants with MM.

The study will assess the safety and effectiveness of ixazomib citrate for its approved indications in a clinical practice setting under real-world conditions.

The study will enroll approximately 165 participants. The data will be prospectively collected, at the centers from medical files and recorded into electronic case report forms (e-CRFs).

All participants will be enrolled in a single observational group:

• Participants With MM

The study will be conducted in South Korea. The overall duration of the study will be approximately 6 years and 11 months. Data will be collected over and up to a 6 months-surveillance period (per participant) once enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with MM.
2. Participants who are prescribed and initiate ixazomib citrate for the treatment of MM according to the ixazomib citrate South Korean product label.

Exclusion Criteria:

1. Participants treated with ixazomib citrate outside of the locally approved label in South Korea.
2. Participants for which ixazomib citrate is contraindicated as per product label.