cyrilzakka/clinical-trials huggingface dataset:
Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) are chronic diseases of the gut comprising Crohn's Disease (CD) and Ulcerative Colitis (UC). The symptoms of IBD consist of diarrhea, abdominal discomfort, weight loss, fatigue and rectal bleeding. However, symptoms and treatment vary between patients. Early management of IBD can lead to better response rates and decrease the risk of irreversible bowel damage and future disease complications such as surgeries. Current clinical tools for diagnosis and or assessing progression of IBD are either invasive (colonoscopy), have low patient acceptance (fecal calprotectin) or low accuracy (C-reactive protein). The purpose of this study is to collect clinical data and samples (including blood, breath and stool) donated by patients with IBD and patients with no IBD (controls) to facilitate research that may result in the development of new non-invasive methods of diagnosing IBD and understand the progression of the disease over time in order to better manage IBD patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as having Crohn's Disease or Ulcerative Colitis
* Aged 18-70 years.
* Understands the language and signs an informed consent form.
* Any disease location, except isolated upper GI Crohn's disease only
* Any CD or UC disease activity.
* Outpatients and inpatients
* Patients will be recruited, and samples obtained at least one day, and no more than one week, prior to out/inpatient colonoscopy preparation to allow objective assessment of disease activity.

Exclusion Criteria:

* Status post colectomy
* Status post diverting loop ileostomy or end ileostomy or colostomy
* On antibiotics in the past 3 months or currently
* Women (pregnant or breast feeding)
* Subjects with concurrent chronic liver, renal, lung or metabolic disorders
* Active malignancy
* Bowel preparation at day of sample procurement
* Isolated upper GI Crohn's disease only
* Active disease on colonoscopy, but normal fecal calprotectin at inclusion
* C diff. positive at time of inclusion (test to be obtained in routine clinical care).
Ultrasonographic Parameters and Life Quality in Nocturnal Shoulder Pain

This study aimed to investigate the effects of nocturnal pain on clinical and ultrasonographic parameters in patients with rotator cuff tendinopathy.

Thirty patients with nocturnal pain, 30 patients without nocturnal pain, and 30 healthy subjects were included in the study. The demographic characteristics and body mass indexes of the patients were recorded. The visual analogue scale was used to determine pain severity. The American Shoulder and Elbow Surgeons Scale Assessment, Short Form-36 and Beck Depression Inventory were used to determine patients' shoulder function, general quality of life and depression levels, respectively. The peak systolic velocity and resistive index of anterior circumflex humeral artery was assessed with power doppler ultrasonography.The peak systolic velocity and resistive index of anterior circumflex humeral artery values of the affected and unaffected sides were compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years diagnosed with rotator cuff tendinopathy

Exclusion Criteria:

* Severe limitation and pain in head and neck movements
* Loss of strength
* Sensation and reflexes loss in the upper extremity
* Limitation in passive shoulder movements on physical examination
* Systemic rheumatic disease
* Diabetes mellitus
* Malignant disease
* Active infection
* Intraarticular injection
* Trauma
* Dementia
* History of surgery
* Bilateral should pain
* Psychiatric discomfort
* Smoking history
* Antiinflammatory drugs or received physical therapy within the last 3 months
* Beck depression score of higher than 13.
BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors

The primary objective of this study is to assess the safety and tolerability of BGB-15025 alone and in combination with tislelizumab; and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended Phase 2 doses (RP2D) of BGB-15025 alone and in combination with tislelizumab in participants with advanced solid tumors.


Eligibility Criteria:
Key Inclusion Criteria:

1. Phase 1a (dose escalation): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available, not tolerated or refused, and who have not received prior therapy targeting HPK1
2. Phase 1b (dose expansion): Participant with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors, including non-small cell lung cancer, esophageal cancer or gastric/Gastroesophageal junction cancer (other solid tumors may be included) who have progressed following systemic anticancer therapies or have no prior systemic treatment for advanced disease
3. At least 1 measurable lesion as defined per RECIST 1.1.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
5. Adequate organ function as indicated by the following laboratory values up to first dose of study treatment: Hemoglobin≥ 90 g/L, Absolute neutrophil count ≥ 1.5 x 109/L , Serum total bilirubin ≤ 1.5 x ULN (\< 3 x ULN for participants with Gilbert syndrome ), AST and ALT≤ 2.5 x ULN

Key Exclusion Criteria:

1. Active leptomeningeal disease or uncontrolled and untreated brain metastasis.
2. Active autoimmune diseases or history of autoimmune diseases that may relapse
3. Any active malignancy ≤ 2 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
4. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment
5. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies

This study explores whether DESI-MS can be used to identify cancerous vs. noncancerous tissue during brain tumor surgery.

PRIMARY OBJECTIVES:

I. To explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to:

Ia. Identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; Ib. Identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and therefore differentiate between IDH-mutant and wild-type gliomas.

OUTLINE: This is an observational study.

Patients undergo tissue sample collection and DESI-MS during standard of care surgery and have their medical records reviewed on study. Patients also undergo MRI per standard of care on study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 18 and older
* Patients or their legally authorized representative (LAR) able to provide written consent
* Schedule to undergo tumor resection

Exclusion Criteria:

* Pregnant women
Feasibility of Delphi Screener for Cervical Cytology

The aim of this study is to see whether a new self-sampling device, the Delphi Screener (Delphi Devices, Scherpenzeel, Netherlands), can be used for cervical cancer screening. The results using the new device will be compared to results using the current gold standard. The gold standard is clinician-collected endo-cervical and ecto-cervical specimens (often referred to as a 'Pap smear'). Additionally, women will be asked about the acceptability of using the device and how easy it is to understand the user instructions.

The Delphi Screener is a sterile, plastic, syringe-like device containing buffered saline which allows a woman to collect her own vaginal lavage (to 'self-squirt'). The hypothesis is that the device may work well for cervical cytology and will be acceptable to the women in the study.


Eligibility Criteria:
Inclusion Criteria:

* Valid Pap smear in last 1-3 months obtained at participating clinic
* 18 years or older
* Self-report being able to read in English and/or Spanish
* Willing to sign informed consent

Exclusion Criteria:

* Used vaginal product (douche, spermicide, antifungal) in last 48 hours
* Last menses started ≤ 4 days prior to enrollment visit
* No uterus / history of hysterectomy
* Self-report currently pregnant
* Self-report currently breastfeeding
A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer

This study has 2 parts: dose finding and dose confirmatory.

In Part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find out what dose of durvalumab administered as an infusion under the skin acts similarly to durvalumab administered into a vein. 24 participants with Non-Small Cell Lung Cancer will be enrolled for a 12 month treatment period and 3 months follow up

In Part 2, the dose confirmation phase of the study, participants will receive the dose of durvalumab identified in Part 1 of the study. The goal of Part 2 will be to learn more about the way that the body processes durvalumab when administered as an infusion under the skin. Approximately 90 participants with Non-Small Cell Lung Cancer will be enrolled; additionally, up to 10 participants with Small Cell Lung Cancer (who will receive concurrent chemotherapy) will be enrolled for a 12 treatment period and a 3 month follow-up period.

AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 (Phase I) completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 (Phase II) was not initiated.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented unresectable Stage III NSCLC that has not progressed following definitive platinum based CRT or extensive disease (Stage IV) SCLC
* ECOG performance status of 0 or 1
* For participants with SCLC: At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 TL at baseline
* Absence of EGFR mutation or ALK rearrangement prior to screening

Exclusion Criteria:

* History of allogeneic organ transplantation
* Autoimmune or inflammatory disorders, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome
* Uncontrolled intercurrent illness
* History of another primary malignancy
* History of active primary immunodeficiency
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
* Brain metastases or spinal cord compression
* Persistent toxicities (CTCAE Grade \>2) caused by previous anticancer therapy, excluding alopecia
* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP
Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life")

Confirmation of efficacy and safety of acoustic CR®-neuromodulation for the treatment of chronic tinnitus patients using the CE marked ANM T30 CR®-system in a real life outpatient setting.

* Identification of early indicators for therapy success
* Comparison of different patient groups regarding: tinnitus severity, tinnitus duration, level of hearing loss, stimulation patterns, unilateral monotonal vs. all other complex forms
* Representative set of safety data in a broad patient spectrum
* Measurement of tinnitus burden (TBF-12 Questionnaire)
* Generation of longterm compliance data


Eligibility Criteria:
Main Inclusion Criteria:

* symptomatic subjective tonal chronical (\> 3 months) tinnitus
* \<60dB hearing loss
* men and women ≥18 years old

Main Exclusion Criteria:

* serious neurologic
* psychiatric or internistic disease
* objective tinnitus
* Morbus Menière
* craniomandibular triggered tinnitus
Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor

Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.

Since progesterone derivatives are useful in preventing preterm labor in cases of risk factors or previous preterm labor, we hypothesize that they will also show efficacy in pregnancy prolongation in women whose preterm labor was arrested following tocolytic treatment.

Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.

This study has the potential to find a treatment to prevent preterm labor and thus to reduce neonatal morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age
2. Tocolytic treatment between 24+0 and 34+0 weeks
3. Patient's consent to participate in this study
4. 24 hours after tocolytic initiation and up to 3 days after finishing the tocolytic treatment
5. Arrest of preterm labor

Exclusion Criteria

1. Contraindication to ongoing pregnancy including:

   1. Suspected amnionitis during testing for eligibility- evidence of active infection including temperature ≥ 38.0°C and uterine tenderness, foul-smelling vaginal discharge, maternal tachycardia of 120 beats per minute or greater, or sustained fetal tachycardia of 160 beats per minute or greater
   2. Evidence of significant placental abruption (contractions and significant bleeding from placental origin)
   3. Intrauterine fetal death diagnosed at the time of admission
2. Major fetal malformation
3. Known maternal allergy to progesterone
4. Current use of progesterone at the time of admission
5. Epilepsy
6. Breast cancer
7. PPROM (preterm premature rupture of membranes) during testing for eligibility
8. Age below 18 years
9. Known active liver disease (elevated liver enzymes at twice the upper normal limit according to medical history or blood test that were taking doring standard medical care)
10. History of deep vein thrombosis
11. Major active psychiatric disorders (major affective disorders and psychotic disorders)
12. Uncontrolled chronic hypertension
13. Heart failure
14. Chronic renal failure
15. Pre-gestational diabetes with known target organ damage
16. History of spontaneous preterm delivery
17. Previous tocolytic treatment during the current pregnancy
Randomised Controlled Trial of the Effect of Music on Women Undergoing Assisted Reproductive Technology Treatments.

To investigate whether listening to music at the time of embryo transfer reduces anxiety levels in women undergoing assisted conception treatment.

An assessor-blinded randomized case control study in an IVF center, England UK will randomise women into 'music' (listened to self-selected music during embryo transfer) or 'control' (no music) groups. Participants will complete the Spielberger State-Trait Anxiety Inventory prior to, and immediately following a post-treatment observation period. Total scores will be compared.

Eligibility Criteria:
Inclusion Criteria:

Eligible participants were women aged between 25-40 years, undergoing IVF or ICSI with fresh or frozen embryos to completion from February 2013 to December 2013.

Exclusion Criteria:

Women unable to consent or with hearing impairment were excluded.
Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training

We are looking at the effects of Stress Management and Relaxation Response training on stress hormones (like adrenalin and cortisol), immune function and physiology (heart rate, breathing rate, muscle tension).

The primary aim of this study is to determine whether differing durations of relaxation response (RR) training will be associated with different degrees of change in physiological, psychological, hormonal, molecular and immunological markers. Prior studies have reported reduction on many of these parameters after 8 weeks of RR training. However, we now seek to understand the degree to which incremental decreases in these parameters are exhibited at 0, 4, and 8 weeks of RR practice in 30 healthy adults. Furthermore, we will explore correlations between levels of exhaled nitric oxide or plasma nitrites/nitrates and oxygen consumption during RR elicitation. We will also examine any associations between changes in oxygen consumption and psychological factors, physiological parameters, and biochemical outcomes. Lastly, we will bank plasma and peripheral blood cells from these samples for future assessments of immune markers, cell typing and gene expression.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-49
* Healthy subjects

Exclusion Criteria:

* Taking medication
* Asthma or allergies
* Prior regular relaxation practice
* Body Mass Index \>39
* Beck Depression Inventory (BDI) score indicates possible clinical depression
* Current mental health treatment
* Diagnosis of severe mental illness
* Using hormonal birth control
* Females: pregnant or trying to conceive
* Exhaled Nitric Oxide (NO) levels \> 60PPB
* Hematocrit \< 32%
* Blood glucose \< 50 or \> 200
* Creatinine \> 1.3
Genetic Investigations in Spontaneous Coronary Artery Dissection (SCAD)

The purpose of the research is to identify mutations (defects in the genetic blueprint) that cause spontaneous coronary artery dissection (SCAD), in other words, spontaneous tears in blood vessels that supply the heart.

Some mutations may be inherited (passed on) from a parent without an apparent blood vessel problem while others may develop for the first time in the affected person.

Study question: Do mutations within certain genes cause or confer susceptibility to spontaneous coronary artery dissection (SCAD)?

Specific aims:

1. Create a genomic DNA and plasma biobank for individuals diagnosed with SCAD.
2. Identify inherited and de novo/new mutations that underlie SCAD.
3. Identify common genetic variants that confer risk for SCAD.

Long term objective:Discover molecular and cellular mechanisms of SCAD and develop biomarkers to enable prediction and prevention.

The purpose of the research is to identify mutations (defects in the genetic blueprint) that cause tears in blood vessels that supply the heart. Some mutations may be inherited (passed on) from a parent without an apparent blood vessel problem while others may develop for the first time in the affected person. The study includes individuals diagnosed with spontaneous coronary artery dissection, their biological parents, and relatives with fibromuscular dysplasia, arterial aneurysm, or arterial dissection.

Adults with SCAD will be identified both retrospectively and prospectively.Confirmation of the diagnosis by review of coronary angiography will be required before proceeding with the informed consent process and blood or saliva sample procurement.

Eligibility Criteria:
Inclusion Criteria:

* Men and women able to give informed consent and complete a 2 page questionnaire
* Diagnosis of one or more episodes of spontaneous coronary artery dissection (SCAD)
* Biological parent of individual with SCAD
* Relative with fibromuscular dysplasia, arterial aneurysm, or arterial dissection

Exclusion Criteria:

* Lack of confirmation of SCAD diagnosis
Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter

This innovative project aims to investigate structures and morphology of the external anal sphincter (EAS) as well as the impact of sacral neuromodulation (SNM) on the EAS morphology and biochemistry among patients with faecal incontinence (FI).

SNM is a well implemented treatment for FI and consist of electrical stimulation of sacral nerve roots to promote continence and may even contribute to total continence. It has shown a positive effects on both short- and long-term. The biologic effect of SNM on EAS is unknown.

The aim is to investigate the effect of SNM on EAS morphology, function, and biochemistry to help physicians and researchers to understand the underlying mechanisms of SNM and the anal sphincter complex to further improve and optimize treatment methods for patients with FI.

The research project consists of three phases. The first phase includes biopsies from the EAS among patients with no previous history of FI. These patients have been diagnosed with rectal cancer and will undergo surgery with abdominoperineal excision.

The second phase includes patients diagnosed with FI and subject for implantation of SNM for treatment of FI. Prior to implantation of SNM all patients will have been examined with 3D endo-anal ultrasound and anorectal manometry as well as answered questionnaires targeting general health, bowel dysfunction and FI. A biopsy of the superficial portion of the EAS is retrieved under local anaesthesia in connection to the test period for implantation of the SNM device.

The last phase, phase three, includes 3D endo-anal ultrasound, anorectal manometry, and a second biopsy of the EAS twelve months after implantation with SNM.

The histopathological analysis in all the three phases will include general morphology, distribution of cell nuclei, satellite cells, muscle fiber type, neural structures and connective tissue.


Eligibility Criteria:
Phase 1

Inclusion Criteria:

* ≥ 18 years of age
* Male or female
* Diagnosed with rectal cancer and receive treatment with abdominoperineal resection
* Signed an informed consent

Exclusion Criteria:

* Previous diagnosis of FI
* Unable to speak and/or read Swedish to ensure informed consent
* Tumour involving the sphincter complex or is in close connection

Phase 2 and 3

Inclusion Criteria:

* Diagnosed with FI and will receive treatment with sacral neuromodulation
* Male or female
* Signed an informed consent

Exclusion Criteria:

* Unable to speak and/or read Swedish to ensure informed consent
Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine

The primary purpose of this study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study (NCT00667602) who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This is measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the response one month post an additional dose of Novartis MenACWY will be measured by percentage of subjects with hSBA titers ≥ 1:8 and GMTs.


Eligibility Criteria:
Inclusion Criteria:

Children eligible to be enrolled in the study were those

* whose parents provide written informed consent;
* were in generally good health based on the clinical judgment of the investigators;
* subjects were 22-45 months of age at the time of enrollment into V59P22E1;
* subject who had participated in the parent V59P22 study.

Exclusion Criteria:

Main exclusion criteria:

* Subjects with serious, acute, or chronic illnesses
* Subjects who had received any other licensed vaccines within 28 days (Exception: Influenza vaccine was allowed up to 14 days prior to and no less than 14 days after the study immunization) prior to enrolment and any study visit
* Subjects who had received any Meningococcal vaccine since the study dose of MenACWY or Men C at 12 months of age in V59P22 trial.