cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults with Refractory or Unexplained Chronic Cough

This is a phase 2b, randomized, double-blind, placebo-controlled study investigating the efficacy, safety, and tolerability of Taplucainium Inhalation Powder (NOC-110) once daily in adults with refractory or unexplained chronic cough.

Approximately 325 participants will take part in the study. It is anticipated that up to 600 participants will be screened. Participation will be approximately 13 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Refractory or unexplained chronic cough for ≥ 12 months.
* Women of childbearing potential agree to follow the protocol specified contraceptive - guidance during the study.
* Males who are not vasectomized must agree to use the contraceptive methods defined in the protocol.
* Able to provide Informed Consent.

Exclusion Criteria:

* Previous exposure to taplucainium (formerly NTX-1175) or known allergy or hypersensitivity to taplucainium, its excipients/metabolites, or related compounds.
* Participants who are currently participating in another drug or device clinical study
* Participants who have participated in an Acute or Chronic Cough investigational study within 60 days before the start of the Screening.
* Current diagnosis of chronic obstructive pulmonary disease, bronchiectasis, unexplained pulmonary fibrosis, hemoptysis, bronchial asthma, or other pulmonary disease.
* Respiratory tract infection within 4 weeks of Screening or during screening period.
* Any female who is pregnant or lactating or wishing to become pregnant.
* Donation of \> 1 Unit (450 milliliter or more) of blood within 90 days prior to the first dosing.
* Alcohol or drug use disorder within the past 2 years.
* Current smoker/vaper or individuals who have given up smoking within the past 6 months, and/or those with \>20 pack-year smoking history.
* Current opiate/opioid use or medical history of opiate/opioid use disorder. History of concurrent malignancy or recurrence of malignancy in the last 2 years.
* Body Mass Index of ≥40 kg/m2.
* Positive results for human immunodeficiency virus, hepatitis B, or hepatitis C virus.
* Unable to refrain from the use of medications and treatments that can impact cough during the study.
* Have clinically significant history or evidence of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s).
The Associations Between Gut Length, Gut Microbiota and Food Assimilation

The purpose of this observational study is to explore the relationships between gut length, the microbiota and food energy assimilation rates in humans.

The focus of this work is to characterize the relationship between gut length, gut microbiota and food energy assimilation rate in healthy individuals.

The gut will be scanned using Magnetic Resonance Imaging (MRI) to calculate gut length. To obtain clearer images, volunteers will be asked to drink 1/1.5 sachet of He Shuang (polyethylene glycol electrolyte powder, molecular weight of 4000) and injected Raceanisodamine Hydrochloride Injection with 10 mg by intramuscular. Volunteers will be asked to drink He Shuang, which dissolved in 1/1.5L of water for the purpose of filling the intestines. As a contrast to improve imaging during scanning.

Volunteers will be given the experimental meal, which providing enough energy for volunteers to eat as much as they want. Feces and urine will be collected to calculate the assimilation rate. To more accurately label the food, edible polyethylene glycol with a molecular weight of 3350(PEG3350) is used. Provides 1.5g of PEG3350 per day, to be used with meals. PEG3350 reaches a steady state in the intestinal tract for 3 days. Food will be provided for seven days during the test period, the first three days are aimed at stabilizing the PEG3350 in the intestine, and the samples to be counted are mainly collected in the last four days. Food assimilation rate and metabolizable energy will be calculated for the 4-day.

The gut microbiota will be analyzed by metagenomics and metabolomics. This study combines metabolomics analysis techniques with imaging and physiological measurements to focus on the potential relationship between gut length and food absorption rates. Researchers anticipate recruiting up to 100 healthy volunteers (body mass index ≥ 18.5).

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-40 years old, healthy and disease free.
* BMI ≥ 18.5;
* Regular bowel movements.

Exclusion Criteria:

* Individuals who are constipated or suffer from intestinal disorders;
* Individuals with mental illnesses such as depression and claustrophobia;
* Individuals with glaucoma and prostate hypertrophy;
* Metal implants in the body;
* Pregnant and lactating women;
* Individuals with blood phobia, pathologic hypotension or hypertension;
* Use of antibiotics, probiotics, oral laxatives within 8 weeks;
* Individuals with metabolic diseases (e.g., chronic diseases such as diabetes mellitus); recent weight loss due to various medical reasons;
* Individuals with infectious diseases (e.g. HIV);
* Irregular diet, lifestyle, addiction to tobacco, alcohol or drugs.
Is Real-time CGM Superior to Flash Glucose Monitoring in Real Life Study (CORRIDA LIFE)

The aim of the investigator's study is to compare real-time continuous glucose monitoring (rt-CGM) and flash glucose monitoring (FGM) in adult patients with Type 1 Diabetes (T1D) in real life practice during 24 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* patients with T1D naive to rt-CGM and FGM
* Type 1 diabetes for \> 1 year
* ≥ 18 years old
* CSII without automatic functions or MDI

Exclusion Criteria:

* previous rtCGM or FGM use
* treatment with insulin pump with automatic functions
* severe noncompliance
* known severe diabetic retinopathy and/or macular edema
* lactation, pregnancy, or intending to become pregnant during the study
* a condition likely to require MRI
* use of acetaminophen-containing medication
* unwillingness to use the study device for \>70% of time
Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC

The study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.

Different works have shown a high rate of virological failure among patients on abacavir + lamivudine + tenofovir or ddI + 3TC + tenofovir, thus rendering the use of these combinations actively unadvisable.

Furthermore, recent studies have also shown that ABC+3TC are associated with a significantly higher increase in CD4 than the current treatment standard formed by AZT+3TC. This provides us with grounds to suppose that patients with TDF+ddI may recover their CD4 with ABC+3HT. Similarly, and recently, the existence of pharmacokinetic interactions between tenofovir + abacavir has begun to be questioned.

Finally, the replacement of tenofovir with abacavir or tenofovir + ddI with abacavir + lamivudine does not detract from the potency of HAART, the toxicity profile is different and their behaviour at mitochondrial level is similar.

This study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* HIV-1 infected patients.
* Patients on triple HAART therapy including ddI + tenofovir plus a PI or NNRTI for at least 3 months.
* Patients with an undetectable HIV-1 viral load (\< 50 copies RNA / mL or \< centre's limit of detection) over the last 6 months.
* Not be on treatment with immunosuppressives, such as: hydroxyurea, interferon, ribavirin or cytostatics.
* Not be on treatment with interleukin-2 or other immunomodulators.
* Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.
* Signature of the informed consent.

Exclusion Criteria:

* Incapacity to give informed consent.
* Bad adherence or treatment interruptions over the previous 6 months.
* Prior exposure to abacavir.
* HAART Therapy including ddI at a dose of 400mg + tenofovir if weight \> 60 kg or ddI 250 mg + tenofovir if weight \< 60 kg.
* Suspicion of cross resistances to abacavir and lamivudine.
* Hepatic or pancreatic analytical alterations 4 times above the limit of normality.
* Presence of opportunistic infections and/or recent tumours (\< 6 months).
* Patients participating in another clinical trial.
Audiological Benefit and Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Contact Mini

Patients with conductive hearing loss fitting the inclusion criteria will be asked to participate in the study. All subjects will be randomized to wear either first the adhesive or the conventional bone conduction hearing aid. They will wear either device for two weeks. They will use the second device for another two weeks. Audiologic tests and quality of life questionnaires will be assessed at the beginning of the study after two weeks with the first device and after two weeks with the second device. Additionally, all patients will be asked to keep a diary including daily wearing time of the device.

The primary objective of this study is to show, that the ADHEAR will be worn \~75%(\~11 to 15 hours per day) of the waking hours, whereas the Contact Mini will be worn \~ 50% (\~5 - 8 hours per day) of the waking hours (p\<0.05). The authors expect this difference due to increased wearing comfort, reduced/no pressure to the skin of the ADHEAR. The primary objective will be assessed with the diary patients are asked to use.

Audiologic testing will consist of free field audiometry, Freiburger monosyllables test and Oldenburg sentence test. All tests will be performed with and without the devices.

Quality of life and hearing related questionnaires will consist of the AQoL-8D and the SSQ12.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria

  * Unilateral and/or bilateral conductive hearing loss (CHL)
  * The bone conduction threshold for the patient's affected ear shall be better than or equal to 25 dB HL (PTA BC for 0.5, 1, 2, 3 kHz).
  * Subjects aged 13 years or older
  * Capable of the German language
  * Willingness and ability to perform all tests required for the study
  * Signed, and dated informed consent before the start of any study specific procedure

Exclusion Criteria:

Exclusion criteria

* Pregnancy or breastfeeding
* Patient is intolerant of the materials as described by Manufacturer's IFU
* Patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter.
* Patient cannot perform the audiological tests or is unable to fill out the questionnaires.
* Patient presents with retrocochlear, or central auditory disorder.
* any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
Comparative Analysis of BioXtra on Xerostomia

The present study compared the efficacy of BioXtra spray and mouth rinse in the relief of radiotherapy-induced xerostomia in patients referred to Cancer Institute, Tehran Imam Khomeini Hospital.

Xerostomia or dry mouth is an important complication of radiotherapy for head and neck regions producing serious discomfort for patients with a significant reduction in their quality of life. Symptomatic treatments for the disease include maintain oral hygiene and use of artificial saliva substitutes.

Due to limited studies on efficacy compounds BioXtra, present study compared the effects of spray and mouth rinse BioXtra in symptoms of xerostomia in patients under head and neck cancer radiotherapy .

Eligibility Criteria:
Inclusion Criteria:

* complaint of xerostomia after head and neck radiotherapy
* patient must have given written informed consent

Exclusion Criteria:

* age under 18 years
* history of any treatment for cancer in the last 3 months
* recurrence of cancer and end stage of it
* diabetes mellitus
* sjogren syndrome or other medical causes of xerostomia
* drug therapy which might induce xerostomia
* refusal of cooperation or consent
mRNA Expression and Genetic Polymorphisms Affecting DRD3 (rs6280) and HTR2A (rs6313) in Bruxism

The goal of this observational study is to learn about the genetic factors influencing bruxism, a condition characterized by teeth grinding, in a group of participants. The main questions it aims to answer are:

* Is there a significant association between the rs6313 polymorphism of the HTR2A gene and bruxism?
* Is there a significant association between the rs6280 polymorphism of the DRD3 gene and bruxism?

Participants will:

Provide DNA samples for genotyping of the DRD3 (rs6280) and HTR2A (rs6313) polymorphisms.

Provide RNA samples to assess changes in the expression of HTR2A and DRD3. Researchers will compare the genetic data and RNA expression levels between individuals with bruxism and those without (controls) to see if there are significant genetic differences and expression changes associated with bruxism.


Eligibility Criteria:
Inclusion Criteria:

* be above 18 years of age and have a confirmed diagnosis of bruxism

Exclusion Criteria:

* Systemic diseases,
* orofacial dysfunction,
* acute symptoms such as neurodegenerative diseases (specifically Parkinsons disease),
* Taking medication such as anxiolytics
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)

The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA


Eligibility Criteria:
Inclusion Criteria:

* JIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one non biologic DMARD or Tumor Necrosis Factor (TNFα) antagonists for at least 3 months prior to screening
* Subjects with TNFα inadequate response (or prior biologic) will be restricted to 30% of the population
* Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease with ≥2 active joints and ≥2 joints with limitation of motion.

Exclusion Criteria:

* Subjects with other rheumatic diseases or major chronic inflammatory/immunologic diseases, active uveitis, systemic JIA with active systemic features (within a period of 6 months prior to enrollment), persistent Oligoarthritis JIA, or failed 3 or more TNFα antagonists or other biological DMARDs will be excluded.
* Active systemic disease: (ie, extra-articular features of systemic JIA including fever, rash, organomegaly) within a period of 6 months prior to randomization.
* Subjects who have failed more than two TNFα antagonists or other biologic DMARDs
Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy

1. Evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy and compare results to co-temporal volume change on grayscale ultrasound and post-treatment mammography findings utilizing final surgical pathology and clinical outcome.
2. Assess incremental benefit of quantitative VCEUS to planar CEUS tumor perfusion measurements and enhancement patterns in predicting tumor response to adjuvant treatment in clinical studies.

The contrast agent Definity® is FDA approved for use as a contrast agent during ultrasound (echocardiography) of the heart. Definity® will be used "off-label" (during ultrasound of the breast) in this study. The administration of Definity® during this study will follow total dose guidelines approved by the FDA.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (age 19 years or older).
2. Patients with newly diagnosed and untreated stage II and III breast cancer scheduled to undergo neoadjuvant chemotherapy.
3. Patients with signed informed consent.

Exclusion Criteria:

1. Any history of prior radiation or chemotherapy for breast cancer.
2. Patients who only have non-measurable disease.
3. Patients who are medically unstable.
4. Patients with other primary cancers requiring systemic treatment.
5. Patients with cardiac shunts.
6. Patients with unstable cardiopulmonary conditions.
7. Patients with known pulmonary hypertension.
8. Patients with known hypersensitivity to any component of Definity (R) microbubble contrast.
9. Patients who are pregnant, breast-feeding or are planning to become pregnant during the study duration.
Assessment of CSF Shunt Flow in an Outpatient Setting with a Thermal Measurement Device

This study collects exploratory data using a non-invasive device for assessing CSF shunt flow using thermal anisotropy measurements. Patients with an existing implanted ventricular CSF shunt will be enrolled into either a prospective (study device) or retrospective (no study device) cohort to gather data on health resource utilization, quality-of-life, and study device measurements.


Eligibility Criteria:
Inclusion criteria

1. Existing ventricular cerebrospinal fluid shunt
2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
3. Subject available for 2 week follow-up
4. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device (Cohort A only)

Exclusion Criteria

1. Presence of more than one distal shunt catheter in the study device measurement region
2. Presence of an interfering open wound or edema in the study device measurement region
3. Subject-reported history of serious adverse skin reactions to silicone-based adhesives
4. Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject
Cetuximab Therapy for Third Line Rechallenge in Metastatic Colorectal Cancer

This research is intended to check the benefit of treatment with cetuximab in metastatic colorectal cancer patients with wild type RAS as third line treatment. The advantage to the patients is unclear. This study will look if mutations in patients' blood area predictive marker for progression free time (FPT) in metastatic colorectal cancer patients treated with third line cetuximab. A predictive marker for FPT metastatic colorectal cancer patients treated with third line cetuximab will enable a reduction in the number of treated patients. Treatment only of patients with a positive marker is expected to prevent inefficient treatment which will reduce suffering for the patients and reduce unnecessary medical treatment.

This research is intended to check the benefit of treatment with cetuximab in metastatic colorectal cancer patients with wild type RAS as third line treatment, following first line cetuximab treatment and other second line treatments. The hypothesis is that most cetuximab sensitive cells will be eliminated in the first line of treatment, but may reemerge following other second line treatments which are targeted to other clones in the tumor. The advantage to the patients is unclear, however some preliminary studies show advantage to patients. This study will look if mutations in patients' blood are a predictive marker for progression free time (FPT) in metastatic colorectal cancer patients treated with third line cetuximab. A predictive marker for FPT metastatic colorectal cancer patients treated with third line cetuximab will enable a reduction in the number of treated patients. Treatment only of patients with a positive marker is expected to prevent inefficient treatment which will reduce suffering for the patients and reduce unnecessary medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18
* Tissue diagnosis of metastatic colon cancer without operational or radiation therapy options
* No RAS mutation in tumor tissue
* Measurable disease according to RACIST criteria v1.1
* ECOG ( Eastern Cooperative Oncology Group) performance status \<=2
* Life expectancy of over 3 months
* Women of fertility age not pregnant
* Ability to understand and sign and informed consent form to participate in the trial and the ability to perform the treatment and follow up required for participation in the trial
* At least three months progression free time in first line cetuximab treatment
* Disease progression according to RACIST v1.1 for first and second lines
* Third line treatment will be applied no less then 17 weeks following and of first line treatment

Exclusion Criteria:

* RAS mutation carriers, or patients with uncertain metastatic colon cancer diagnosis
* Patients operated two weeks prior to accepting trail drug, or that did not recover from treatment
* Level 3 allergic response to any of trial drugs
* First line cetuximab treatment stopped due to allergic response
* Severe medical or mental diagnosis which might increase the risk in drug administration according to treating physician's discretion
* Pregnant or lactating women
A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary

The goal of this observational study is to learn about the treatment effectiveness of physician's choice of chemotherapy and the immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed/refractory ovarian clear cell carcinoma (OCCC), and compare the treatment response with the phase II, single-arm clinical trial INOVA to investigate the efficacy of combinational therapy of sintilimab plus bevacizumab. The main questions it aims to answer are:

* What is the efficacy of physician's choice of chemotherapy in relapsed/refractory OCCC patients in the real world?
* Is ICI-based therapy more effective than physician's choice of chemotherapy in real-world for relapsed/refractory OCCC patients?
* Dose the combinational regimens of sintilimab plus bevacizumab in Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma (INOVA) trial more effective than physician's choice of chemotherapy?

Participants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients with age ≥ 18 years old and ≤ 75 years old.
2. There must be a histological diagnosis of ovarian clear cell carcinoma.
3. Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy.
4. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
5. Expected survival time ≥ 12 weeks.

Exclusion Criteria:

1.Histological evidence of non-ovarian clear cell carcinoma.