cyrilzakka/clinical-trials huggingface dataset:
The PATH Study to Promote Physical Activity After Knee Replacement

The purpose of this study is to examine the feasibility and preliminary efficacy of a physical therapist led physical activity intervention for knee replacement patients within an outpatient physical therapy facility.

Physical activity does not typically increase after knee replacement; thus, the purpose of this study is to examine if physical activity levels will be higher among knee replacement patients who receive a physical therapist led physical activity intervention during standard physical therapy sessions. Physical activity levels will be assessed at the start of outpatient therapy and at 12 weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Be 40-79 years of age
* Have had a knee replacement in the last 2 months
* Be willing to wear and accelerometer for 7 days during assessments
* Be English speaking

Exclusion Criteria:

* Have any contraindications to activity
* Have a mobility limiting comorbidity
* Have a scheduled surgery within the next 6 months
Seoul National University Airway Registry

This is a multicenter, prospective observational cohort study, in which patients with chronic airway diseases including chronic obstructive pulmonary disease(COPD), asthma, asthma-COPD overlap syndrome (ACOS) will be recruited.


Eligibility Criteria:
COPD

Inclusion Criteria:

* Postbronchodilator FEV1/FVC \< 0.7 AND chronic respiratory symptom

Exclusion Criteria:

-

Asthma

Inclusion Criteria:

* Never smoker or \<5PY of smoking history AND Recurrent episodes of asthma symptoms (wheezing, dyspnea, chest tightness, cough) AND (either Positive BDR OR positive metacholine/mannitol/exercise provocation test)

Exclusion Criteria:

-

ACOS

Inclusion Criteria:

* COPD AND Asthma (regardless of smoking status)

Exclusion Criteria:

-
Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children

To evaluate the clinical efficacy of probiotic gummies in the trial of allergic rhinitis in children compared to placebo, as well as the modulating effect on gut microbiota, serum metabolic profile, and occurrence of adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

1. Age 4-14 years old;
2. Meet the diagnostic criteria for allergic rhinitis established in the Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in Children (2022 Revised Edition);
3. Symptoms: 2 or more symptoms: sneezing, watery discharge, nasal itching and nasal congestion and other symptoms persist or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, watery eyes and red eyes;
4. Signs: pale and edema of the nasal mucosa, which may be accompanied by watery discharge;

Exclusion Criteria:

1. Drugs that affect the intestinal flora have been used continuously for more than 1 week within 1 month before screening;
2. Patients with pulmonary tuberculosis;
3. Combined with allergic asthma;
4. Those with nasal polyps or severe nasal septum deviation;
5. Patients with severe systemic diseases or malignant tumors;
6. Those with congenital genetic diseases and congenital immunodeficiency diseases;
7. Those who regularly use probiotics or prebiotics within 6 months before the screening period;
8. Those with severe digestive tract diseases (including severe diarrhea, inflammatory bowel disease, etc.);
9. Patients with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.);
10. Patients with sinusitis, otitis media, or respiratory tract infection;
11. Those who are allergic to the probiotic-related ingredients used in this trial;
12. Subjects who are judged by other investigators to be insuitable to participate.
Colonoscopy is an Aerosol Generating Procedure

With a commercially available particle counter, we can differentiate the particle counts of different sizes in different areas of the endoscopy room. An increase from baseline particles of \< 5um during or after the procedure would suggest that the procedure is an AGP.

In this study, the particle counter from Met One Instruments model GT-526S will be used. A particle sizer is placed within 10cm of the anus, at the level of the endoscopists' face and at the level of the endoscopy nurse assistant's face The change in the particles of different sizes would be simultaneously recorded. The results of these three locations are compared to baseline and compared with each other

Currently, the term droplet is often taken to refer to droplets \>5 microns (μm) in diameter that fall rapidly to the ground under gravity, and therefore are transmitted only over a limited distance (e.g. ≤1 m). In contrast, the term droplet nuclei refers to droplets ≤5 μm in diameter that can remain suspended in air for significant periods of time, allowing them to be transmitted over distances \>1 metre. With a commercially available particle counter, we can differentiate the particle counts of different sizes in different areas of the endoscopy room. An increase from baseline particles of \< 5um during or after the procedure would suggest that the procedure is an AGP.

In this study, the particle counter from Met One Instruments model GT-526S will be used. The study will be conducted in the Prince of Wales Hospital endoscopy centre. A particle sizer is placed within 10cm of the anus, at the level of the endoscopists' face and at the level of the endoscopy nurse assistant's face The change in the particles of different sizes would be simultaneously recorded. The results of these three locations are compared to baseline and compared with each other.

Eligibility Criteria:
Inclusion Criteria:

- All patients who are planned for colonoscopy in the Prince of Wales Hospital, Hong kong

Exclusion Criteria:

* Patients where a flexible sigmoidoscopy was plannned Patients where the procedure was done in a negative pressure room Patients where the procedure was done in an endoscopy room other than the designated rooms Patients where the procedure was done under general anaesthesia
Pathophysiological Implications of the Incretin Hormones in Maturity Onset of Diabetes of the Young (MODY)

The purpose of this study is to describe the incretin effect and postprandial incretin response in patients with MODY2 and MODY3 and a group of matched healthy subjects. In sulphonyl urea treated subjects the purpose is also to compare the incretin effect with and without treatment. In healthy subjects the purpose is also to investigate the incretin effect under increased levels of endogen incretin hormones.

Comparison of of insulin secretion (AUC) during the experimental days. Furthermore a comparison of GIP, GLP1 and glucagon responses as well as plasma glucose levels.

Eligibility Criteria:
Inclusion Criteria:

* Caucasians above 18 years
* BMI \> 19 kg/m2
* Negative pancreatic beta cell- and glutamate decarboxylase-65(GAD65)- autoantibodies
* Normal haemoglobin
* Normal bloodpressure
* Informed concent

Exclusion Criteria:

* Known liver disease or affected liver enzymes (ALAT/ASAT \>2 x upper normal limit)
* Nephropathy (see creatinine\> 130 μM and / or albuminuria)
* Treatment with medications that cannot be discontinued for 12 hours
* Any condition that the investigators feel would interfere with trial participation
* Pregnancy or lactation
The Effect of Warming and Vibration Applications on Pain in Newborns

This study aimed to determine the effects of warming and vibration applications on pain during heel blood collection in newborns.

H1: Warming application has a positive effect on pain during heel blood collection in newborns.

H2: Vibration application has a positive effect on pain during heel blood collection in newborns.

H3: The combined application of warming and vibration during heel blood collection in newborns has a positive effect on pain.

Heel blood collection is frequently used for neonatal metabolic screening and analysis of bilirubin, glucose and other biochemical/hematologic parameters. This process is both painful and stressful for the newborn. Pain experience in the neonatal period can cause intense stress in the infant and cause physiopathological changes such as respiratory irregularity, impaired thermoregulation, changes in heart rhythm, changes in oxygen saturation and blood pressure. Therefore, it is recommended to use evidence-based non-pharmacological methods to reduce the pain experiences of newborns and to minimize the short and long-term negative effects of pain.

Based on this rationale, this study was planned to evaluate the effect of non-pharmacologic methods on pain and procedure time together.

Eligibility Criteria:
Inclusion Criteria:

* Newborns at 38 weeks of gestation and above
* Healthy newborns

Exclusion Criteria:

* Newborns with any lower extremity anomalies
* Newborns with congenital diseases
A Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Participants With Relapsed/Refractory Acute Myeloid Leukemia (AML) Cancer

This is an open-label, Phase 1, dose-escalation (Segment 1) and expansion (Segment 2) study to determine the maximum tolerated dose (MTD) and/or the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-744 in participants with relapsed/refractory Acute Myeloid Leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

* Participant must have AML not amenable to curative therapy, refractory to standard of care therapy or for which standard of care therapy does not exist. Participants who are candidates for stem cell transplantation must have been offered this therapeutic option.
* Must consent to provide biomarker analyses as described in the protocol.
* Must have an Eastern Cooperative Oncology Group (ECOG) Performance status of:

  * Dose Escalation (Segment 1): 0 - 1
  * Dose Expansion (Segment 2): 0 - 2
* Dose Escalation: Must have a serum albumin during Screening of \>= 3.0 g/dL.
* Participant has adequate bone marrow, renal and hepatic function.

Exclusion Criteria:

* Participant with known active Central Nervous System (CNS) disease.
* Participant has received anti-cancer traditional medicine or anti-cancer herbal remedies within 14 days prior to ABBV-744 dosing. Saw palmetto is considered anti-cancer herbal remedy. Participant has received anti-cancer therapy within a period of 14 days or 5 half-lives (whichever is longer; except for immunotherapy where a period of 21 days will be acceptable) prior to Study Day 1. Except for hydroxyurea which will be allowed during screening and treatment for controlling leukocytosis.
* Participant has been previously treated with a Bromodomain and Extra-Terminal (BET) inhibitor
* Participant has unresolved clinically significant toxicities from most recent prior anti-cancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE v 4.03) grade 2 or higher clinically significant toxicity (excluding alopecia).
* Participant has received the following within 7 days prior to the first dose of study drug: corticosteroid therapy, CYP3A inhibitors, CYP3A inducers.
* Participant consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
* Participant had major surgery within 28 days prior to Study Day 1.
* Participant is unable to swallow or absorb oral tablets.
* Participant has known infection with hepatitis B or hepatitis C.
* Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis, enteritis, colitis.
* Participant has symptoms of gross hematuria or gross hemoptysis
* Has electrocardiogram with a QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 msec or ECG with second degree type 2 or third degree atrioventricular block.
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve participants with follicular lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease.
* Measurable disease
* Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities.
* Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
* Adequate hematologic function within protocol-defined parameters.
* Adequate hepatic and renal function within protocol-defined parameters.
* ECOG performance status score of 0-2.

Exclusion Criteria:

* Transformed lymphoma
* Prior treatment for follicular lymphoma.
* Central nervous system lymphoma or leptomeningeal disease.
* Currently active, clinically significant cardiovascular disease.
Effects of OMT on Premature Physiological Parameters

Osteopathic manipulative treatment has been showed to reduce LOS in premature infants. Despite the clinical effectiveness, lack of data and information on the physiological underpinning effects during the treatment has been revealed. The aim of the study is to explore the immediate physiological effects of osteopathic treatment on premature infants


Eligibility Criteria:
Inclusion Criteria:

* preterm infants

Exclusion Criteria:

* congenital/genetic disease
* cardiovascular/neurological disease
Forel's Field Electrical Stimulation for Lennox-Gastaut Syndrome

The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Forel's Field H as adjunctive therapy for alleviating symptoms in Lennox-Gastaut Syndrome.

This project aims to include 5 participants, and evaluate the effectiveness and safety of Forel's Field H stimulation in patients with Lennox-Gastaut Syndrome through a prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with Lennox-Gastaut Syndrome with alternative treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Participants are between the ages of 14 -35 years of age.
* Patients must be clinically evaluated as having Lennox-Gastaut syndrome.
* Persistence of disabling seizures at least 5 times per months or greater.
* After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory.
* Informed consent signed.

Exclusion Criteria:

* Psychogenic non-epileptic seizures within 12 months;
* Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
* Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
* IQ \< 55 or severe cognitive dysfunction, unable to complete the study;
* Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
* Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
* Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function;
* Pregnant, or planning to pregnant within 2 years;
* Participation in another clinical study within 3 months;
* Not suitable for enrollment as assessed by the multidisciplinary team of the center.
Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS

The purpose of this study is to investigate the effects of two treatment techniques called Expiratory Muscle Strength Training (EMST) and Lung Volume Recruitment (LVR) on breathing, swallowing, speech, and cough function in persons with mild to moderate ALS. Half of the participants will do EMST alone, and the other half of the participants will do EMST and LVR.


Eligibility Criteria:
Inclusion Criteria:

* ALS defined as possible, laboratory-supported probable, probable, or definite by El Escorial criteria
* Reduced Maximal Expiratory Pressure (MEP) compared to norms for age and sex
* Forced Vital Capacity (FVC) \> 65% predicted

Exclusion Criteria:

* Inability to provide informed consent
* Relative contraindications to LVR, including known pneumothorax, active internal bleeding, unstable hypertension, unstable angina, emphysema, recent barotrauma, or FEV1 (Forced Expiratory Volume, trial 1)/FVC ratio \< 0.7.
* Use of EMST or breath stacking \> 3 days/week within 12 weeks of screening
* Amyotrophic Lateral Sclerosis-Cognitive Behavioral Scale (ALS-CBS) score predictive of dementia (≤ 10)
* Participation in another clinical trial of an intervention in ALS within 30 days of study enrollment or during study enrollment
A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 1 to 4 other available medications to prevent their migraines, but these medications have not helped them.


Eligibility Criteria:
Key Inclusion Criteria:

* The participant has a diagnosis of migraine as defined by International Classification of Headache Disorders Third Edition (ICHD-3) guidelines confirmed at the Screening Visit.
* The participant has a history of migraine onset ≥ 12 months prior to the Screening Visit.
* The participant has a migraine onset at ≤50 years of age.
* The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has documented evidence of treatment failure in the past 10 years of at least 1 to 4 (maximum) different migraine preventive medications.

Key Exclusion Criteria:

* The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (anti-PACAP treatment).
* The participant has confounding and clinically significant pain syndromes.
* The participant has a diagnosis of acute or active temporomandibular disorder.
* The participant has a history or diagnosis of confounding headaches.

Additional protocol-defined criteria apply.
A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma

Surgical resection followed by concurrent chemoradiotherapy is considered as the standard of care for locally advanced OSCC (LAOSCC). Although the treatment could provide prompt local control, but it is also associated with high incidence of distant failure. Systemic chemotherapy given either before (neoadjuvant) or after (adjuvant) definitive local treatment has been extensively evaluated to improve the clinical outcome in LAOSCC. Regimens of taxane/cisplatin-based combinations have been shown to improve the treatment outcome of patients with locally advanced head and neck squamous cell carcinoma (HNSCC) in neoadjuvant setting. Recently, cetuximab (Erbitux®), a monoclonal antibody against epidermal growth factor receptor (EGFR), has also been proven to be an efficient agent for advanced and/or refractory HNSCC with acceptable toxicity profiles. In current study, we shall evaluate the feasibility, efficacy and safety of a triplet bio-chemotherapy consisting of cetuximab, paclitaxel, and cisplatin followed by cetuximab-based concurrent bio-radiotherapy (CBRT) in patients with LAOSCC.

Patients with high-risk, locally advanced (TxN2b\~3 or T4N0\~3, M0) OSCC will be eligible. To detect an interested objective response rate (p1) of 80% versus a non-interested response (p0) rate of 60%, with an α and 1-β of 0.05 and 0.2, respectively (two-sided test), including the estimated dropout rate of 10%, a total of 47 patients will be recruited.

Eligibility Criteria:
Inclusion Criteria:

1. High-risk, locally advanced (TxN2b\~3 or unresectable T4, M0) OSCC
2. Histologically confirmed squamous cell carcinoma
3. Performance status: Eastern Cooperative Oncology Group performance status (ECOG) 0-1
4. age 18 years or older, less than 70 years of age
5. Having signed informed consent
6. Measurable disease by CT or MRI
7. Adequate hematologic, hepatic and renal function

Exclusion Criteria:

1. Prior radiotherapy for targeted lesions, chemotherapy, EGFR pathway targeting therapy
2. Prior surgery for cancer except for the purpose of diagnostic biopsy
3. Concomitant active 2nd malignancies or disease-free of malignancies \< 3 years before the study except adequately treated in situ cervical cancer, or non-melanoma skin cancer
4. Concomitant anticancer therapies within the past 28 days
5. Severe cardiopulmonary diseases and other systemic disease under poor control
6. Uncontrolled chronic neuropathy
7. Women who are positive of pregnancy, or in breast-feeding
8. Known allergy to any study treatment
9. Legal incapacity
10. Significant disease which, in the investigator's opinion, would exclude the patient from the study
Preoperative Skin Preparation Evaluation

Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.

Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.

This study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with the proposed new product, the currently approved product and the placebo.

Eligibility Criteria:
Inclusion Criteria:

* Free of dermatoses, cuts, lesions, or other skin disorders on or around the test sites; no exposure to topical or systemic antimicrobials, antibiotics, or steroids (other than contraceptives, for the fourteen (14) day pre-test conditioning period and must agree to abstain from these materials until completion of the study

Exclusion Criteria:

* Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions,
* Use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the fourteen(14) day pre-test conditioning period or during the test period;
* Exposure of the test sites to strong detergent, solvents, or other irritants during the fourteen (14) day pre-test conditioning period or during the test period;
* Use of systemic or topical antibiotic medications, steroid medications other than contraceptives, or any other product known to affect the normal microbial flora of the skin during the fourteen ()14) day pre-test conditioning period or during the test period;
* Know of allergies to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate, and/or isopropyl alcohol;
* A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, any immunocompromised conditions such as AIDS (or HIV positive), mitral valve prolapse, or a requirement to take antibiotics prior to dental procedures;
* Pregnancy, plans to become pregnant within the pre-test and test periods of the study, or nursing a child;
* Any active skin rashes or breaks in the skin of the test sites;
* A currently active skin disease or inflammatory skin condition, including contact dermatitis; showering or bathing within the seventy-two (72) hour period prior to sampling; participation in another clinical study in the past thirty (30) days or current participation in another clinical study;
* Any medical condition or use of any medications, that, in the opinion of the Study Director, should preclude participation;
* Unwillingness to fulfill the performance requirements of the study.