cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes

The aim of this trial is to confirm the efficacy of HR17031 in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged 18-75 years at the time of signing the informed consent (both ends included)
2. Body Mass index (BMI) of 20.0-40.0 kg/m2 (both ends included)
3. Diagnosed with type 2 diabetes for at least 90 days prior to screening
4. Tested by local laboratory, HbA1c is 7.5%-11% (including both ends)
5. Before screening, the daily basal insulin dose had been stabilized at 20-40U/ day (including both ends) for at least 60 days
6. When screening:

   ①metformin monotherapy stable treatment ≥3 months; or

   ②metformin combined with another OAD for stable treatment for ≥3 months; Metformin dose ≥1500 mg/ day or maximum tolerated dose.
7. Ability and willingness to comply with protocol requirements, including self-monitoring of blood glucose, recording subject diary, and using pre-filled injection pen.

Exclusion Criteria:

1. Known or suspected allergy to the investigational drug product or its components or excipients;
2. Systemic glucocorticoid use within 3 months prior to screening
3. Use of weight loss drugs within 3 months prior to screening
4. Received insulin therapy within 1 year prior to screening (excluding short-term therapy \[continuous treatment ≤14 days\] or insulin therapy for gestational diabetes);
5. Cardiovascular disease, defined as congestive heart failure (NYHA III-IV), unstable angina pectoris, stroke (except lacunar infarction without symptoms), myocardial infarction, coronary revascularization within 6 months prior to screening; And/or coronary, carotid, or peripheral arterial revascularization is planned at screening
6. (with or without treatment) uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
7. Proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, intermittent claudication at screening;
8. Patients diagnosed with mental disorders; Mentally incapacitated or speech impediment, unable to fully understand the trial protocol or unwilling to collaborate;
9. Known or suspected abuse of alcohol or narcotics;
10. Previous history of pancreatitis (acute or chronic)
11. During pregnancy or lactation;fertile women (WOCBP) or men who have fertility plan or unwilling to use appropriate contraceptive methods from the signing of the informed consent to 3 months after last use of the investigational drug product;
12. Any condition, determined by the investigator, interfere with the efficacy or safety results of the trial.
Effects of Imaginary Resisted Exercise Versus Physical Resisted Exercise on Hand Grip Strength in Stroke Patients

The goal of our study is to make a comparison between the effectiveness of physical resistance exercise and imaginary resistance exercise in improving handgrip strength, dexterity, and eye-hand coordination among stroke patients.

A Randomized Control Trial study will be conducted in which patients with stroke will be allocated to Group A that will receive imaginary resistance exercises and patients in group B will receive physical resistance exercises.

The intervention will be applied (3 days /week) for 12 weeks, which consists of 5 different types of resistance using 5 different resistive objects, each will have 15 repetitions. Each session includes handgrip exercises with physical resistance exercises for one group and imaginary resistance exercises using Virtual Reality Box for another group. As for improving dexterity and eye-hand coordination, the Purdue pegboard test and finger-to-nose test will be used respectively in both groups with 15-15 repetitions.

Eligibility Criteria:
Inclusion Criteria:

* Age should be in the range from 50 years to 75 years
* Time passed since stroke attack should be more than one year.
* Grade of Manual Muscles Testing for Elbow and Wrist, Flexion / Extension should be more than 2 out of 5.
* Scoring of Modified Ashworth Scale should be more than 3 out of 5 for the same muscle groups of previously mentioned movements.

Exclusion Criteria:

* Any significant pain present in the affected upper limb.
* Increased muscle tone that interferes with movements of the affected upper limb.
* Serious sensory loss in the affected upper limb.
* Severe medical issues currently.
* Cognitive impairment to a level that interferes with sessions of intervention.
* Impairments of vision that disables patient to perform interventional exercises.
* Serious presence of apraxia / neglect.
* If enrolled for any related or alike other upper limb therapy sessions / interventional studies.
SBRT Combined with Nimotuzumab and Tislelizumab for Oligoprogressive Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of Immunotherapy

This study is a single-arm, open-label, prospective, and exploratory investigation aimed at examining the short-term efficacy, specifically the objective response rate (ORR), of SBRT combined with Nimotuzumab followed by Tislelizumab in patients with recurrent/metastatic nasopharyngeal carcinoma who have experienced oligoprogression (1-5 metastatic lesions) after immunotherapy.


Eligibility Criteria:
1. Inclusion Criteria:

   1.1. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma; 1.2. Patients with recurrent/metastatic nasopharyngeal carcinoma who have previously received first-line treatment including anti-PD-1 immune checkpoint inhibitor therapy and failed, presenting with oligoprogression (1-5 metastatic lesions); 1.3. Eligible to receive SBRT, Tislelizumab, and Nimotuzumab; 1.4. No history of other malignant tumors; 1.5. Male or female, aged 18-75 years; 1.6. Liver function: Total bilirubin ≤ Upper Limit of Normal (ULN); AST and ALT ≤ 2.5 × ULN; Alkaline phosphatase ≤ 5 × ULN; 1.7. Renal function: Creatinine clearance ≥ 80 mL/min; 1.8. Hematological tests: Absolute neutrophil count (ANC) ≥ 2 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL; 1.9. No severe dysfunction of heart, lung, and other vital organs; 1.10. Performance Status (PS) score ≤ 2.
2. Exclusion Criteria:

2.1. Disagree to sign the informed consent form; 2.2. Patients who cannot comply with regular follow-ups due to psychological, social, family, or geographical reasons; 2.3. Receiving other experimental treatments as part of a clinical study (during the treatment period of the clinical study); 2.4. Severe, uncontrolled infections or medical conditions; 2.5. Major organ dysfunction, decompensated heart, lung, kidney, or liver failure, unable to tolerate radiotherapy or immunotherapy; 2.6. Factors affecting drug administration, distribution, metabolism, or excretion, such as mental abnormalities, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc.; 2.7. Overexposure to glucocorticoids within 2 weeks before immunotherapy; 2.8. Long-term use of immunosuppressive agents after organ transplantation.
Effect of Acupressure-Ice Message on Primary Dysmenorrhea

This study will be conducted to determine the effect of acupressure ice massage on primary dysmenorrhea.

Dysmenorrhea is considered the most common gynecological complaint by young women and affects approximately 60-80% of the female population. Around 8-18% of that population report intense discomfort, causing absenteeism in several daily activities while suffering pain.

Analgesics are considered the first line of treatment, but they are known for their undesirable effects such as renal, cardiovascular and gastrointestinal complications that can negatively affect patients' health. Physical therapy has alternative techniques that assist in analgesia in a practical and effective way; among them is acupressure and cryo therapy.

The effect of application of ice on the skin has a direct action on neurons and pain receptors, lowering the speed and the number of nerve impulses. This effect is due to its action on the gate control of pain mechanism, leading to the release of endorphins and enkephalins that are pain-relieving substances.

It was proved from previous studies that using ice massage on L14 or SP6 points reduce pain intensity in females suffering from PD. So, further studies are needed to investigate the effect of acupressure ice massage not only on pain intensity but also on other symptoms severity and quality of life of females suffering from PD. Therefore, this study will be conducted for this issue which will be of valuable benefits for medical service organization and increase body of knowledge of physical therapy in scientific field.

Eligibility Criteria:
Inclusion Criteria:

* Fifty adolescents' females who are clinically diagnosed as primary dysmenorrhea.
* Their ages will be ranged from 17-25 years old.
* Their BMI will be less than 30 kg/m².
* All of them are virgin.
* Their pain level will be more than 3 on visual analogue scale.
* Having mild to moderate score on Menstrual Distress questionnaire (MDQ) ( ≥ 50).
* Having regular menstruation for the last 6 months (every 28-30 days with no intermittent bleeding).

Exclusion Criteria:

* Systematic chronic diseases or any pelvic inflammatory diseases.
* Secondary dysmenorrhea.
* Menstrual irregularity.
* Nerve damage resulting in loss of feeling.
* Swelling, scar or skin infection.
* Diabetic patients.
IMU-based Assessment of Motor Control in a Population of Young Subjects With Paramorphisms and Dysmorphisms

While various complex pathologies of the developmental age, such as Infantile Cerebral Palsy or Neuromuscular Diseases, are notoriously considered causes of alteration of locomotor development, it is scarcely known whether conditions much more frequent in the pediatric population, the so-called "Paramorphisms or Dysmorphisms", may be associated with more or less noticeable changes in locomotor development.

On a few studies, flat feet and hyperlaxity has been correlated with a motor control delay or poorer motor performance, based on complex clinical tests or on stereophotogrammetry movement analysis.

Although promising, these preliminary studies, in addition to not providing information on the possible influence of other paramorphisms, such as varus and valgus of the knees, do not provide conclusive indications.

The aim of this study is to investigate, through clinical tests and wearable inertial units, the motor control of a pediatric population affected by Paramorphisms or Dysmorphisms and to compare them with a population of healthy controls, matched by age, taken from the recently developed control data set from Bisi and Stagni.


Eligibility Criteria:
Inclusion Criteria:

* Born at term
* Without known delay in motor development
* Finding of one or more paramorphisms or dysmorphisms of the developmental age (flat or cavus foot, valgus or varus talipes, valgus or varus knee, scoliotic attitude or scoliosis, hyperkyphosis or hyperlordosis, generalized or focused hyperlaxity, heterometry of the AAII, torsional defects AAII)

Exclusion Criteria:

* Preterm birth
* Diagnosis of pathologies compromising motor control (Infantile Cerebral Palsy, Neuromuscular Diseases, Spina Bifida, Arthrogryposis, Genetic Syndromes)
Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery

Regional anesthesia, also know as a nerve block, is a key component of pain control after major abdominal surgery. Bilateral erector spinae plane block (ESPB) performed at low thoracic level has been shown to be an effective pain control method in case reports. This pilot study aims to further characterize the pain-control characteristics and to provide baseline data for future trials.


Eligibility Criteria:
Inclusion Criteria:

Adult surgical patients who are American Society of Anesthesiologists (ASA) class I to III, undergoing cystectomy, or total abdominal hysterectomy, salpingo-oophrectomy with or without omentectomy via midline laparotomy.

Exclusion Criteria:

1. BMI \> 40
2. Non-English speaking
3. Patient refusal or inability to consent
4. Cognitive or psychiatric history that would make it difficult to assess pain score
5. Pre-existing chronic pain condition
6. Preoperative opioid use greater than the equivalent of oral morphine 30 mg daily
7. Infection over site of block placement
8. Allergy or contraindication to any study medication
9. Coagulopathy or thrombocytopenia
10. Postoperative ICU admission
11. Presence of significant cardiac, respiratory, hepatic, renal or neurologic diseases
Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms

Exocrine Pancreatic Insufficiency (EPI) is a condition where pancreatic enzyme quantity or activity is reduced below threshold needed for normal digestion. Symptoms include bloating, flatulence, diarrhea and steatorrhea. This is an observational study assessing for effect of CREON on symptoms of EPI in participants with EPI due to chronic pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

* Medical history of chronic pancreatitis (CP).
* Diagnosis of Exocrine Pancreatic Insufficiency (EPI).

Exclusion Criteria:

--History of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypass surgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritable bowel syndrome
CHRONOtype-adjusted DIET on Weight Loss

BACKGROUND: Several reports have observed that the alteration of normal biological rhythms is associated with obesity development. In this regard, those subject with the preference for evening seems to be prone to develop obesity. However, the current treatment of obesity does not take into account these aspects OBJECTIVE: To evaluate whether a diet adjusted to patient's chronotype is more effective than the current dietary recommendations.

SUBJECTS/METHODS: 209 subjects take part in a randomized, double-blind clinical trial. 104 subjects followed a typical hypocaloric dietary treatment (CONTROL) and the other 105 subjects undergone a diet with a daily caloric distribution adjusted to their chronotype (CHRONO).

CONCLUSIONS: A chronotype-adjusted diet may be a promising alternative to the classical hypocaloric dietary treatment since the investigator's data indicate a higher effectiveness regarding weight loss when the diet was adjusted to the patient's chronotype.


Eligibility Criteria:
Inclusion Criteria:

* students or staff of the Catholic University of Murcia (UCAM), with an age ranged between 18 and 65 years old

Exclusion Criteria:

* clinically significant illnesses (including type 2 diabetes, chronic heart failure, hepatitis and cancer)
* those taking any medications known to affect body weight (thyroid hormones, corticosteroids, etc.)
* women in special physiological situations (pregnant, lactating).
Continuous Glucose Monitoring to Measure Effect of Glycemic Index

Background: Post-prandial hyperglycemia is common in people with type 1 diabetes.

Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring.

Design: Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low GI; in the other, high GI. Meals were given 195 minutes apart and were matched for carbohydrate, protein, and fat content. Each subject received his usual pre-prandial insulin dosage, followed by a continuous subcutaneous basal insulin infusion for the remainder of the experiment. Arterialized venous glucose was analyzed every 15 minutes and sensor glucose was recorded every 5 minutes.

A total of 14 diet studies (each with two meals) were completed in three men and four women. All subjects completed two diet studies in which two meals were served 195 minutes apart. On one study day, two high GI (\> 75) meals were given, and on the other study day, two low GI (\< 30) meals were given. The low GI and high GI meals were matched for amount of carbohydrates, protein, and fat based on a weight-maintaining diet for each subject. The order of the study treatment (high or low GI) was randomized. Subjects were not informed as the GI of any meal.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of type 1 diabetes mellitus
* patients on insulin pump therapy

Exclusion Criteria:Any patient who was

* pregnancy
* cardiovascular, cerebrovascular, kidney, or liver disease
* uncontrolled chronic medical conditions
* oral or parenteral corticosteroid use
* immunosuppressant use
* visual or physical impairments that impede the use of a continuous glucose monitoring device
* insulin or glucagon allergy
* hypoglycemia unawareness
* requirement of greater than 200 units of insulin per day
* gastroparesis
* any prior gastric surgery
* an allergy to any food items served.
Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors

RATIONALE: Questionnaires that measure quality of life may help doctors identify the effects of treatment and improve the ability to plan treatment for patients with gastrointestinal-related neuroendocrine tumors.

PURPOSE: This phase IV clinical trial is studying how well a disease-specific questionnaire works in assessing the quality of life of patients with gastrointestinal-related neuroendocrine tumors.

OBJECTIVES:

Primary

* Test the scale structure, reliability, and validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21) in patients with gastrointestinal-related neuroendocrine tumors.

Secondary

* Determine the quality of life of patients using QLQ-C30 and the QLQ-G.I.NET21 before and after treatment.

OUTLINE: This is a multicenter study. Patients are stratified according to treatment (somatostatin analogue therapy or interferon therapy vs radionuclide therapy or chemotherapy vs ablative therapies \[embolization or radiofrequency ablation\] or liver resection).

Patients complete the EORTC C30 questionnaire, QLQ-G.I.NET21 module, and are evaluated for Karnofsky performance status at pretreatment, at 3 and 6 months after treatment, and then 2 weeks later. Patients also complete a clinical data and sociodemographic data form and debriefing questionnaire at pretreatment; a follow-up form at 3 months and 6 months after treatment; and a test-retest form 2 weeks later.

PROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed neuroendocrine tumor OR characteristic radiological findings of neuroendocrine tumor with raised hormone levels in plasma or urine meeting any of the following criteria:

  * Primary disease in gut with liver metastases (with or without hormone secretion)
  * Primary disease in lung with liver or abdominal metastases (with or without hormone secretion)
  * Primary disease in pancreas with or without metastases (with or without hormone secretion)

PATIENT CHARACTERISTICS:

* Any Karnofsky performance status allowed
* Life expectancy ≥ 3 months
* Able to understand the questionnaire language
* Mentally fit to complete questionnaire
* No psychological, familial, sociological, or geographical condition that would limit study compliance
* No other concurrent malignancies except basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

* More than 2 months since prior somatostatin analogue or interferon therapy (somatostatin therapy stratum)

  * Concurrent somatostatin analogue and/or interferon therapy allowed if dose stable over the past month
* More than 6 months since prior radionuclide therapy or systemic chemotherapy (radionuclide or systemic chemotherapy stratum)
* More than 6 months since prior ablative therapies (ablative therapy stratum)
* No concurrent participation in other quality of life studies
Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib (firmonertinib) at 2 dose levels (160 mg once daily \[QD\] and 240 mg QD) compared to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations. A target of approximately 375 patients will be randomized in a 1:1:1 ratio to treatment with furmonertinib 240 mg QD, furmonertinib 160 mg QD, or platinum-based chemotherapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing.
* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
* Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months.
* Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.
TracelT Hydrogel in Localizing Bladder Tumors in Patients Undergoing Radiation Therapy for Bladder Cancer

This pilot clinical trial studies how well TracelT hydrogel works in localizing bladder tumors in patients undergoing radiation therapy for bladder cancer. TracelT hydrogel marks the location of a bladder tumor and makes it more visible during imaging tests. Using TracelT hydrogel tissue marker may help doctors learn more about tumor location and altering radiation dosage for bladder cancer.

PRIMARY OBJECTIVES:

I. To utilize the TraceIT hydrogel tissue marker in localizing bladder tumors during transurethral resection of bladder tumors (TURBT).

II. To improve identification of gross tumor or tumor bed location in patients receiving chemoradiation treatment for bladder cancers.

SECONDARY OBJECTIVES:

I. To report adverse events surrounding the placement of the TraceIT tissue marker.

II. To calculate the actual dose received by the bladder tumor bed, as delineated by the hydrogel.

III. To compare the dosimetric impact to the tumor bed of daily patient alignment to the pelvic bones, versus alignment to the whole bladder, versus alignment to the hydrogel markers.

IV. To calculate the amount of normal tissue radiation dose decrease achievable without losing tumor coverage, with better tumor targeting with hydrogel placement.

OUTLINE:

Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignancy of the bladder
* No prior cystectomy
* Treatment plan for bladder must include at least 4 weeks of daily radiation treatment (most patients will receive chemotherapy concurrent with radiation, but this is not required for trial enrollment)
* Patient must undergo TraceIT hydrogel placement within 8 weeks prior to starting radiation therapy for bladder cancer
* Participants must have a complete history and physical examination within 60 days of study entry
* Participants must be able to provide informed consent for treatment and trial participation
* No restrictions on prior treatment to be eligible

Exclusion Criteria:

* Prior cystectomy
* Unable to have TraceIT hydrogel placement \< 8 weeks prior to beginning radiation treatment
* Treatment for metastatic bladder cancer