cyrilzakka/clinical-trials huggingface dataset:
Cross-condition Validation of the Steroid PRO

Testing a questionnaire about treatment with steroids for skin, lung or gastric conditions

Glucocorticoid drugs, also known as 'steroids', are used to treat a range of diseases. It is well-known that steroids can cause many unwanted side-effects. The investigators are interested in measuring the impact of steroids on quality of life, from the patients' perspective.

In a previous part of this study, the investigators interviewed participants treated with steroids for a range of rheumatic conditions. The participants were asked how taking steroids affects their everyday lives. A patient questionnaire (the 'Steroid PRO') was then created focused on the topics identified as being most important to participants.

Now the investigators would like to test this questionnaire with new participants, aged 18 or over, who are taking steroids for other conditions. This could include participants who have inflammation in the lungs, skin, or bowels. The investigators will also ask for feedback from the medical teams who care for those who have these conditions.

The study involves a single interview with a researcher, either online or by telephone. Participants who want to take part will be given information about the study and asked to give written consent. Participants will be asked to talk about the wording of the questionnaire and how relevant and feasible it is to them.

This part of the study is funded by Sanofi Research and Development. The work is being carried out by independent researchers at the University of the West of England (UWE, Bristol). Participants will be recruited from hospitals in the UK and USA.

The investigators hope that the Steroid PRO questionnaire will be used in future research trials about steroid treatment and alternatives to steroids. The Steroid PRO questionnaire could also be used in clinics to improve communication between clinicians and patients.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* Diagnosed with an autoimmune or inflammatory respiratory, gastroenterology or dermatology condition
* Treatment with glucocorticoids with intravenous or oral glucocorticoids for an autoimmune or inflammatory condition within the previous year (or longer duration).
* Ability to give consent.

Exclusion Criteria:

* Aged \<18 years old
* No autoimmune or inflammatory respiratory, gastroenterology or dermatology diagnosis
* Not treated with glucocorticoids with intravenous or oral glucocorticoids for an autoimmune or inflammatory condition within the previous year (or longer duration)
* Unable to give consent
Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors

HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors.

This is a multicenter, open-label, Phase Ib clinical trial of HS-20117 combination therapies to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity in participants with advanced solid tumors. The study includes a dose escalation part and a dose expansion part. The dose-escalation study will be performed to evaluate the safety, tolerability, PK profile, immunogenicity, and efficacy of HS-20117 combination therapies in participants with advanced solid tumor. The subsequent dose-expansion study will be performed to evaluate the efficacy of HS-20117 combination therapies in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations or EGFR classical mutations, and RAS/BRAF V600E wild type CRC.

Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 - 75 years (inclusive).
* Histologically confirmed unresectable, recurrent or metastatic solid tumors.
* At least one target lesion per the RECIST v1.1.
* ECOG performance status of 0-1.
* Minimum life expectancy \&amp;amp;gt; 12 weeks.
* Males or Females should be using adequate contraceptive measures throughout the study.
* Females must not be pregnant at screening or have evidence of non-childbearing potential.
* Signed Informed Consent Form.

Exclusion Criteria:

* Received or are receiving the following treatments:

  1. Any anticancer therapy targeting MET, including TKIs, antibodies or antibody-drug conjugates.
  2. Monoclonalor bispecific antibodies targeting EGFR.
  3. Systemic anti-cancer treatment (Cytotoxicities and anti-cancer Traditional Chinese medicine or TKIs) within 2 weeks prior to the first dose of HS-20117.
  4. Investigational anti-cancer drugs or antibodies or ADCs within 4 weeks prior to the first dose of HS-20117.
  5. Local radiotherapy within 2 weeks prior to the first dose of HS-20117, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of HS-20117.
  6. Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
  7. Major surgery within 4 weeks prior to the first dose of HS-20117.
* Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
* Presence of uncured secondary primary malignancies.
* Untreated, or active central nervous system metastases.
* Severe, uncontrolled or active cardiovascular disorders.
* Serious infection within 4 weeks prior to the first dose of HS-20117.
Core Stability, Symmetrical Weight-bearing Stroke

To evaluate the effect of core stability exercise on symmetrical weight bearing in chronic stroke patients?

Stroke is a syndrome characterized by quickly emerging clinical indicators of a focal (or global) disruption of brain function. The symptoms can last for more than 24 hours or even result in death, and there is no known reason for them other than vascular origin. Over 80% of all strokes are caused by an ischemic stroke. A large artery blockage typically results in tissue infarction, which is the non-selective loss of all brain cells in the affected areas of the brain if it is not quickly reversed. Determining the location and size of these infarcts is crucial. the long-term functional deficits resulting from ischemic stroke. After a stroke, patients' ability to bear weight symmetrically is similarly compromised; they may bear between 61 and 80% of their body weight on a non-paretic leg. Physiotherapy procedures targeted at enhancing core stability can enhance the lumbopelvic-hip musculature's strength, coordination, and endurance, potentially reducing physical deficits linked to compromised trunk function. Because these muscles are crucial for both stability and lumbar posture control (by the employment of Core stability is commonly utilized in whole-body exercises to enhance the strength of the muscles around the stomach, lumbar, and pelvic regions, whether they be tonic or postural muscles. The trunk is the body's center pivot point, serving as a vital component for functional activity, balance, postural control, and extremity coordination. Consequently, the trunk is very important. in the recovery procedure. There is a substantial body of research demonstrating that Trunk control, balance when sitting and standing, and mobility can all be improved with trunk training. in stroke patients, according to recent studies in systemic reviews. So, the purpose of the current study was to detect the effect of core stability exercise on symmetrical weight bearing in patients with chronic stroke

Eligibility Criteria:
Inclusion Criteria:

1. Forty hemiparetic patients were diagnosed and referred to by a neurologist.
2. All patients must be ambulant
3. The spasticity of lower limbs ranges from (grade 1: 1+) according to Modified Ashworth Scale.
4. Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental Scale \>24). (
5. Age ranges from 50 to 65 years in both sexes.
6. Duration of stroke was more than 6 months up to 24 months. -

Exclusion Criteria:

* The patients were excluded if they had any of the following:

  1. Musculoskeletal disorders such as severe arthritis grade (3-4) of osteoarthritis, lower limb fractures less than 6 months or contractures of fixed deformity.
  2. Cognitive impairment (a score less than 24 according to the MMSE)
  3. Patients with diabetic neuropathy.
  4. Recurrent stroke.
  5. Rheumatologic or endocrinologic disorders that may cause ROM restriction.
  6. Patients suffering from cognitive, or emotional disturbance.
Intracoronary Thrombus Detection by Magnetic Resonance Imaging

This study involves the use of Magnetic Resonance Imaging (MRI) to determine whether blood clots can be identified within the blood vessels supplying blood to the heart in patients with angina and who have recently suffered a heart attack.

The majority of heart attacks are caused as a result of small blood clots forming within the blood vessels supplying blood to the heart, obstructing blood flow to the heart muscle. Research has also shown that blood clots may form in the blood vessels of the heart without causing a heart attack. At present, blood clots may be identified by techniques used during invasive coronary angiography, but we wish to determine whether a non-invasive test (MRI scanning) can be used to detect small blood clots within the blood vessels supplying blood to the heart muscle.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years
* Previously diagnosed coronary artery disease undergoing elective invasive angiography (Cohort 1) OR
* Admitted with Acute Coronary Syndrome (ACS) diagnosed by two of the following criteria;

  1. Elevation of cardiac biomarkers (high sensitivity troponin I greater than 34ng/l in men and 16ng/l in women).
  2. Symptoms of myocardial ischaemia
  3. Electrocardiogram (ECG) changes indicative of acute ischaemia (Cohort 2)
* Planned invasive coronary angiography

Exclusion Criteria:

* Contraindication or inability to undergo MRI scanning
* Renal failure (estimated glomerular filtration rate less than 30millilitres/minute)
* Undergoing Primary Percutaneous Coronary Intervention
* Ongoing myocardial ischaemia or dynamic ECG changes
* Inability to provide informed consent
* Known allergy to gadolinium based contrast
* Women who are pregnant, breastfeeding or of child-bearing potential
Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma

The purpose of this study is to determine if treatment with Topotecan by an alternative method, delivering topotecan directly into brain tumors, is safe and well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of supratentorial WHO Grade III or IV Glioma (High Grade Glioma) that has undergone surgical biopsy or resection followed by adjuvant chemoradiotherapy, that has evidence of recurrence or progression based on imaging studies and a stereotactic biopsy is indicated for confirmation of recurrence/progression.
* 18 years of age or older
* Karnofsky Performance Status 70-100;
* MRI demonstration of a stereotactically accessible enhancing or predominantly non- enhancing mass that does not require resection to relieve clinically significant mass effect;
* Participant understands the procedures and agrees to comply with the study requirements by providing written informed consent
* Adequate organ function as indicated in protocol

Exclusion Criteria:

* Participant is mentally or legally incapacitated at the time of the study;
* Known HIV(+) or has been diagnosed with AIDS
* Participation in another investigational drug study in the prior 4 weeks
* Positive pregnancy test in a female
* Patient, in the opinion of the investigator, is likely to be poorly compliant.
* Diffuse subependymal or Cerebral Spinal Fluid (CSF) disease
* Tumors involving the cerebellum
* Tumor enhancement involving both hemispheres
* Active infection requiring treatment
* Unexplained febrile illness
* Radiation or chemotherapy within 4 weeks of enrollment
* Systemic diseases associated with unacceptable anesthesia or operative risk
* Inability to undergo magnetic resonance imaging (MRI)
Ask Advise Connect (AAC) Harris Heath CPRIT

The goal of this behavioral research study is to learn about the outcomes of smoking cessation treatment. Researchers want to learn how many smokers stopped smoking after taking part in smoking cessation treatment with the Texas Quitline.

Study Test:

If you agree to take part in this study, you will collect a saliva sample to test for cotinine to confirm your smoking status. Cotinine is a chemical released in your body when it breaks down nicotine. You will receive a kit in the mail with supplies for the testing. The study staff will call you to make sure that you received the kit and to discuss the instructions with you. To collect the saliva, you will put a small piece of cotton in your mouth for a few minutes. You will mail the saliva sample back to the study staff, using a postage-paid envelope.

Length of Study:

Your participation in this study will be complete after you collect the saliva sample and mail it back to the study staff. Study data will be destroyed 5 years after the study has been completed and the data has been analyzed. Data collected in this study will not be used for future research.

This is an investigational study.

Up to 1,459 participants will be enrolled in this study. All will be enrolled at Harris Health System clinics.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Self-reported current smoker
3. Present for care at one of the 13 Harris Health System (HHS) community clinics
4. Has a working telephone number

Exclusion Criteria:

1) None
Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia

Phase 2 clinical trial to evaluate the combination of venetoclax, cytarabine and metformin in relapsed-refractory and induction ineligible acute myeloid leukemia.

Subjects will be included voluntarily after informed consent. Diagnosis of AML in accordance with the WHO classification and determination of inegibility to induction therapy or refractory or relapsed disease after initial treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AML in accordance with the World Health Organization criteria.
* Ineligibility for induction chemotherapy due to age (≥ 70 years) or, for patients 18 to 74 years of age, ECOG-PS 2 or 3, creatinine clearance below 60 mL/min/1,73m², left ventricular ejection fraction ≤ 50%.
* Projected life expectancy of at least 12 weeks.
* Not requiring supplemental oxygen or substitutive renal therapy.
* Female participants must be either postmenopausal, surgically sterile or practicing at least one protocol specified method of birth control starting at Study Day 1 through at least 180 days after the last dose of study drug.
* Male participants must agree, from Study Day 1 through at least 180 days after the last dose of study drug, to practice protocol specified methods of contraception and to refrain from sperm donation from initial study drug administration through at least 180 days after the last dose of study drug.
* Participant must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria:

* Diagnosis of acute promyelocytic leukemia (APL).
* Known central nervous system (CNS) involvement with AML.
* Known human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, or other active viral, bacterial or fungal infection requiring treatment.
* History of other malignancies prior to study entry, with the exception of non-melanoma skin cancer.
* Chronic Liver Disease and Cirrhosis with a class B or C Child-Pugh score.
Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study

The purpose of this study is to evaluate the feasibility of a Percutaneous Lead Management Kit for HeartMate II driveline stabilization and exit site management.

The Percutaneous Lead Management Kit is a combination of commercially available components that are packaged together in a kit to be used for HeartMate II driveline exit site cleaning, dressing and stabilization. The RESIST study is a prospective, non-randomized study to evaluate the wearability and usability of the Percutaneous Lead Management Kit. Evaluation of the Percutaneous Lead Management Kit for wearability and usability will be performed for 30 days from enrollment. Study patients will also be followed for up to 6 months for any evidence of driveline infection.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* 16 years of age or older
* Supported by HeartMate II LVAD continuously for at least 6 months and not currently hospitalized
* Will continue on LVAD support for at least another 30 days
* No driveline or systemic infection
* Willing and able to perform kit dressing changes at least once every 7 days for 30 days
* Can fill out study forms
* Can use a digital camera
* Willing to return to clinic for final study visit in 30 days

Exclusion Criteria:

* High risk for non-compliance
* Ongoing mechanical circulatory support other than HeartMate II LVAD
* Sensitivity to kit components
* Skin condition that may react to kit component adhesives
* Already using all components of Percutaneous Lead Management Kit
Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy

This study evaluates the local cytokine inflammatory response during one lung ventilation in patients undergoing pulmonary lobectomy or wedge resection. We compare two different ventilation strategies: a conventional strategy with a protective strategy.

One-lung ventilation (OLV) is a ventilation procedure used for pulmonary resection often causing lung injury. International guidelines have recommended for years the use of conventional ventilation (CV) with high tidal volume (VT) (8-10 ml\\kg).A body of recent evidences have shown that conventional ventilation can reduce systemic oxygenation, increase inflammatory products and cause lung tissue damage. In this study we compare the conventional strategy , consisted of Vt 10 mL/kg, with the protective strategy, consisted of Vt 5 mL/kg. Both Vt were based on predicted body weight (PBW). Broncho-alveolar lavages (BAL) are selectively performed in the dependent (ventilated) lung before and at the end of the OLV. The levels of pro-inflammatory (IL-1α, IL-1β, IL-6, IL-8, TNF) and anti-inflammatory (IL-2, IL-4, IL-10, INFγ) cytokines are evaluated. We also evaluate patients clinical outcomes in terms of incidence of postoperative respiratory complications and length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective lobectomy and wedge resection

Exclusion Criteria:

* emergency surgery, pregnancy, patient refusal, inability to give consent, age ≤ 18 years and ≥ ASA IV
Caffeine vs. ALA in BMS Treatment. (BMS: Burning Mouth Syndrome. ALA: Alpha-Lipoic Acid.)

The aim of this study was to evaluate the efficacy of caffeine and alpha-lipoic acid in the treatment of burning mouth syndrome by symptom assessment with visual analogue scale.

The etiology of BMS is multifactorial, involving a complex interplay of neuropathic, psychological, neuroendocrine, and immunological factors. Neurologically, BMS has been categorized into three subtypes: peripheral small fiber neuropathy, subclinical trigeminal neuropathy, and inhibitory dopaminergic deficiency. Neuroimaging and peripheral nerve studies have further implicated altered brain activation patterns and increased expression of specific receptors like TRPV1 and P2X3 in the pathogenesis of BMS. Hormonal imbalances, particularly in estrogen levels, have also been suggested to contribute to contribute to the condition.

Caffeine, a xanthine alkaloid chemically known as 1,3,7-trimethylxanthine, is recognized for its diverse biological functions. As a central nervous system stimulant, its primary mechanism involves antagonizing adenosine receptors, thereby enhancing the release of neurotransmitters such as dopamine and norepinephrine, which are known to play roles in analgesic pathways. Caffeine is also noted for its neuroprotective properties and is theorized to reduce the risk of neurodegenerative diseases. It affects the central processing of pain and is involved in regulating circadian rhythms and sleep-wake cycles. Additionally, caffeine has mild anti-inflammatory properties. Its stimulatory effects may also improve mood and cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age
* Diagnosis of BMS according to the 3rd edition of the International Classification of Headache Disorders (ICHD-3)
* Daily intraoral burning or dysaesthesia lasting for more than 2 hours for over 3 months
* Normal oral mucosa and sensory testing
* Condition not better accounted for by another ICHD-3 diagnosis

Exclusion Criteria:

1. Secondary BMS due to local or systemic disorders
2. Prior treatment for BMS
3. Psychiatric or progressive neurological disorders
4. Systemic disorders potentially associated with oral disease
5. Long-term history of smoking, drinking, or medication use
6. Consumption of caffeinated products
7. Poor oral hygiene
8. Abnormal blood test results (including blood count, glucose, serum iron, ferritin and transferrin, folic acid, or vitamin B12 levels)
9. Incomplete medical records
10. Unwillingness to participate