cyrilzakka/clinical-trials huggingface dataset:
A Multicenter, Prospective Cohort Study of Preserved Ratio Impaired Spirometry(PRISm) in a Population

Chronic obstructive pulmonary disease (COPD) is the most common chronic tract disease and the third leading cause of death worldwide. The treatment effect of COPD is poor, and the disease is progressive, resulting in a serious disease burden. The key reason is that early recognition is difficult and the early pathophysiological mechanism is unclear, which leads to the difficulty of early intervention.PRISm is likely to be the precursor stage of COPD, which may provide an important research object for the study of pathophysiological characteristics, inflammation and immunomodulatory mechanisms of early COPD, and may also become a new entry point for early intervention of COPD. This study attempts to establish a PRISm prospective cohort，and collects blood, EBC and urine for analysis of inflammatory factors, metabolomics, proteomics and microbiome, and performs chest HRCT to obtain imaging indicators, and conducts 3-year dynamic follow-up observation to study the evolution characteristics of pulmonary function and the incidence of COPD in the PRISm cohort. To compare the differences in imaging, inflammatory factors, metabolomics, proteomics and microbiome among the three PRISm groups, and establish a risk prediction model for progression to COPD through PRISm. It lays a foundation for understanding the characteristics of COPD at an earlier stage and exploring new early warning indicators.


Eligibility Criteria:
Inclusion Criteria:

* 1) Age range from 20 to 75 years old, regardless of gender; 2) Pulmonary function test: After inhaling bronchodilators, FEV1/FVC ≥ 70%, and FEV1\<80% of the expected value; 3) Agree to enter this research project and sign an informed consent form 4) Able to comply with research protocols.

Exclusion Criteria:

* 1) Confirmed chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, interstitial lung disease, occupational lung disease, tuberculosis, pulmonary vascular disease, central airway stenosis and other confirmed respiratory diseases.

  2) Have undergone lobectomy and/or lung transplantation; 3) complicated with serious underlying diseases (including serious mental illness, mental retardation, neurological disease, malignant tumor, chronic liver disease, heart failure, autoimmune disease, chronic kidney disease); 4) accompanied by severe pleural disease and/or lesions of the sternum or ribs; 5) Have active tuberculosis or are receiving anti-tuberculosis treatment; 6) Pregnancy or lactation; 7) Can not be followed up for a long time or poor compliance;
Tislelizumab and Radiotherapy for Recurrent Cervical Cancer

This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel plus bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. The total treatment periods are no more than 6 cycles. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.


Eligibility Criteria:
Inclusion Criteria:

1. The patient voluntarily participates and signs informed consent
2. Aged 18 years of age or older
3. Has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 7 days prior to the first dose of study treatment
4. Has recurrent cervical cancer and controllable local treatment, indicating an indication for radiation therapy
5. Willing to accept concurrent radiotherapy combined with Tislelizumab
6. Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the local investigator
7. Has adequate organ function
8. Has expected survival time ≥3 months

Exclusion Criteria:

1. Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
2. Has a known history of Human Immunodeficiency Virus (HIV) infection，active Hepatitis virus infection and active tuberculosis (TB; Bacillus tuberculosis)
3. Has known active central nervous system (CNS) metastases and/or uncontrolled, untreated carcinomatous meningitis with elevated intracranial pressure
4. Has received a major surgery within 4 weeks prior to signing informed consent
5. Not suitable for radiotherapy
6. Reassessment of liver and kidney function and blood routine indexes after radiotherapy did not meet the above criteria
7. Did not meet the other requirements for inclusion by the investigator
8. Judged unqualified of the enrollment requirements by the researcher according to other conditions
Spelling Mistake Tolerant Word Prediction for Working, Writing and Communicating

The main objective of the PREDICT4ALL project is to provide written communication in a computer, reducing the number of spelling errors for each user.

The effectiveness of written communication is defined in this study by the number of spelling errors for each user. Word prediction (and therefore correction) must be able to be configured by a therapist (speech therapist, occupational therapist).

Adapting the prediction to user errors should also allow it to be more relevant throughout the text input. This software efficiency must increase text input speed, Reduce the cognitive load, establish a classification of spelling errors adapted to the context of text input speed and develop the word prediction module tolerant of these spelling errors.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 6 and 25 years old For center 1
* patient with dysorthographia
* educational level greater than or equal to CE2
* A developmental level in reading on the Evalouette test (Evaleo battery) greater than or equal to CE1 For center 2
* Neurologic disorder impacting communication

Exclusion Criteria:

* Patient's refusal to participate in the study
* Persons under guardianship
* Pregnant women
* No affiliation to a social security scheme (beneficiary or beneficiary)
* Having visual disturbances preventing the use of the computer tool
Comparison Of Outcome Of Different Layers in Hypospadias Surgery

To compare the outcome of applying autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery. A total of 220 patients fulfilling the selection criteria were admitted after taking informed consent. Cases were randomly divided into groups A and B using a random generator of the Excel program. In group A, dartos flap and PRP sheet layer were applied and in group B, only a preputial dartos fascial flap was applied

Objective To compare the outcome of application of autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery.

Methods This randomized controlled trial was conducted at Pediatric General surgical department, the Children's hospital and the University of Child health, Lahore for the period of 12 months. Non probability, purposive sampling was used for data collection and randomization was done to assign the treatment. Total of 220 patients fulfilling the selection criteria were admitted after taking an informed consent. Cases were randomly divided into two groups A and B using random generator of Excel program. In group-A, dartos flap and PRP sheet layer was applied and in group-B, only a preputial dartos fascial flap was applied.

Eligibility Criteria:
Inclusion Criteria:

* patients (Age 6months to12 years) with mid, distal penile or sub coronal hypospadias having minimal chordae were included in the study

Exclusion Criteria:

* Patients having proximal hypospadias, moderate to severe chordae, previously operated cases, a preoperative androgens treatment (for example in penoscrotal hypospadias and small sized phallus) were excluded from study
Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions

The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule dose in subjects fed a high standard fat meal.

This was an open label, randomized, balanced, single dose, two-period, two-treatment, two-sequence crossover study, performed under fed conditions. Subjects were confined to the SFBC Clinical Research Facility from at least 10 hours prior to drug administration, until after the 24-hour post-dose blood draw, in each period. The treatment phases were separated by a washout period of 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Is the individual a healthy, normal adult man or non-child bearing potential woman who volunteers to participate?
* Is s/he at least 18 years of age?
* Is his/her BMI between 19 and 30, inclusive?
* Is s/he considered reliable and capable of understanding his/her responsibility and role in the study?
* Has s/he provided written informed consent?

Exclusion Criteria:

* Does the individual have a history of allergy or hypersensitivity to zonisamide or sulfonamides?
* Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
* Does s/he have serious psychological illness?
* Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse?
* Does s/he have a positive urine drug screen, or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test?
* Has s/he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation?
* Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken?
* Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?
* Is s/he unable to refrain from the use of all concomitant medications during the study?
* Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
* Has s/he donated plasma during the two week period preceding study initiation?
* Has s/he received an investigational drug during the 30 day Period preceding study initiation?
The Relationship Between Body Composition and Growth Hormone, SIRT Signaling, Protein Turnover and Insulin Sensitivity

The purpose of this study is to investigate signaling pathways in fat and muscle, as well as turnover of protein, sugar and fat after stimulation with growth hormone and during fasting in lean and obese subjects. This will help clarify differences in the human metabolism between lean and obese subject and provide us with a better understanding of the molecular mechanisms regulating the basic metabolism during prolonged fasting.

In an evolutionary context, it is likely that "inherited" obesity provides a survival advantage when there are shortages of food, but also increases the risk of lifestyle diseases in times of prosperity. This may explain the high incidence of obesity, diabetes and cardiovascular disease in the western world today. Obese individuals have high levels of free fatty acids (FFAs) in the blood and FFAs are both protein sparing (giving an evolutionary survival advantage) but also cause increased insulin resistance (which increases the risk of diabetes and cardiovascular disease). Obesity also leads to low growth hormone (GH)-levels, whereas fasting is accompanied by high GH- and FFA-levels and increased IGF-I mRNA in muscle. It is likely that obese individuals are more capable of fasting than lean individuals and will lose less protein during fasting, have increased activation of GH signaling and altered activation of other signaling proteins. And obese individuals are likely to be more sensitive to growth hormone than lean individuals based on FFA-responses, intracellular signaling, protein loss and insulin sensitivity.

We would like to test 3 hypotheses: (1) Obese individuals are more capable of fasting than lean individuals and will lose less protein during fasting (2) Activation of lipolysis is an important prerequisite for limiting protein loss during fasting in both slim as obese individuals. (3) Obese individuals are more sensitive to growth hormone than lean individuals based on FFA responses and activation of intracellular signals. The hypotheses are tested in 8 lean and 8 obese healthy young men, who are studied 4 times: (i) after 12 hours of fasting (ii) after 72 hours of fasting (iii) after GH-bolus (0.005 mg/kg over 20 min.) and (iv) after 72 hours of fasting with inhibition of fat metabolism (tablet acipimox 250 mg every 4 hours) during the last 12 hours of fasting and during the study period.

Each study period consists of a 4-hour basal period and a 2 hour hyperinsulinemic euglycemic clamp (30 mU/m2/min). Muscle- and fat-biopsies are taken and analyzed for enzyme expression and activation of various signaling pathways. The study subjects are given glucose-, amino acid-, urea- and palmitate-tracers and specific hormones and metabolites are measured for assessment of underlying molecular mechanisms regulating the basic human energy metabolism.

Eligibility Criteria:
Inclusion Criteria:

* healthy lean (BMI19-25) and healthy obese (BMI 32-40) men
* written consent before study start

Exclusion Criteria:

* known medical conditions
* any medication
A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants

The purpose of this study is to assess how fast pegilodecakin gets into the blood stream and how long it takes the body to remove it, when given as a solution formulation via a prefilled syringe (PFS) versus from a vial drawn into a conventional syringe. Information about side effects will be collected. The study is open to healthy participants. Total participant duration in trial is approximately 42 days.


Eligibility Criteria:
Inclusion Criteria:

* Must have a body mass index (BMI) between 19.0 and 32.0 kilograms per meter squared (kg/m²) at study screening
* Must be Human Immunodeficiency Virus (HIV) negative by HIV 1/0/2 testing.
* Must be Hepatitis B (HBV) surface antigen negative
* Must be Hepatitis C (HCV) antibody negative
* Females must have a negative serum pregnancy test

Exclusion Criteria:

* Pregnant or lactating subjects
* Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing
* Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
* Have smoked or used tobacco/nicotine products within 90 days prior to the study dosing
* Have been treated with systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
* Have been vaccinated within 90 days of study dosing
Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product

People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.

To overcome this, Coloplast has developed a new supporting ostomy product called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status.

The overall aim of this clinical investigation is to evaluate the benefits of the new supporting product, Heylo compared to Standard of Care.

The Investigational device - Heylo, is already CE-marked.

The investigation is an open-labelled, randomized cross-over trial with two test periods evaluating Heylo and Standard of Care.

In total 144 subjects having an ileostomy or an colostomy will be included and randomized.

Eligibility Criteria:
Inclusion Criteria:

* Has given written consent to participate by signing the Informed Consent Signature Form.
* Is at least 18 years of age and has full legal capacity.
* Has an ileostomy or colostomy with consistent liquid/mushy fecal output (5-7 Bristol scale\*)
* Is able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm).
* Has experienced leakage\*\* under the baseplate at least three times within the last fourteen days. \*\*Leakage defined as output seeping under the baseplate"
* Has worry about leakage to "some degree, high degree, or very high degree" (on a five-point Likert scale: Very low degree/Not at all, Low degree, some degree, High degree, very high degree)
* Is willing to refrain from use of ostomy paste.
* Has a smartphone compatible with the Heylo™ application
* Is able to follow study procedures for 4 months (assessed by investigator or delegate)

Exclusion Criteria:

* Is participating in other clinical investigations or has previously participated in this investigation
* Is pregnant or breastfeeding
* Has known hypersensitivity towards any of the products used in the investigation
* Is using/ has a pacemaker
A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease

Determine the baseline characteristics of patients who have recurrent symptomatic genital herpetic disease Determine the acceptance to patients of clinical trial procedures Determine interest in participation in genital herpes vaccine trials


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and willing to sign the informed consent document.
* Patient confirmation of a diagnosis of HSV-2 infection at least 2 years prior to inclusion. Laboratory confirmation is not required.
* Symptomatic recurrent genital herpetic disease for \>2 years supported by compatible clinical history

Exclusion Criteria:

* Subjects who do not meet the inclusion criteria for the study
* Subjects who are unable to provide legally effective informed consent
Enhanced Recovery After Surgery Program for Colorectal Cancer: a Multi-center Study (ERASC1)

This study is aimed to evaluate the safety of applying enhanced recovery after surgery for colorectal cancer.

In China, Europe and America, colorectal cancer is one of common malignant tumors. It is very important for treatment of colorectal cancer to enhance the quality of treatment, increase patients' survival rate and improve the life quality. So far, surgical resection is optimal treatment for patients with colorectal cancer. As a result, increasing the quality of surgery and improving the perioperative managements have a great influence on patients received a coloproctectomy. Investigators have spent over ten years studying enhanced recovery after surgery programs for colorectal cancer and have got some successful experience. Investigators found enhanced recovery after surgery can accelerate patients' recovery without increasing complications. This study is the first multi-center study of enhanced recovery after surgery for colorectal cancer in China. During this period, the study is aimed to evaluate the safety of applying enhanced recovery after surgery for colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Requirements of informed consent and assent of participant, parent or legal guardian as applicable
2. Patients with colorectal cancer scheduled for radical coloproctectomy and between the age of 18 and 75 years old without considering sex
3. ASA physical status I-III
4. Participants can follow the drug doses and visit plan

Exclusion Criteria:

1. Patients certified by a doctor that doesn't fit to participate in this study.
2. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function \> II (NYHA) patients, patients received CABG recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).
3. Patients with colorectal cancer with distant metastasis.
4. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance \< 25 ml/min).
5. Patients allergic to common drugs, such as opioids, non-steroidal drugs, cephalosporins, etc.
6. Patients with operations of gastrointestinal cancer and complicated abdominal operations.
7. Patients complicated by colorectal cancer with complications such as hemorrhage, perforation, obstruction.
8. Patients with dyscrasia and severe malnutrition (albumin≤30g/L, weight loss in half a year\>10%, SGA classification C, BMI\<18, Hb\<70g/L).
9. Patients with metabolic complications caused by diabetes.
10. Patients can't finish enhanced recovery after surgery programs and have contraindications of enhanced recovery after surgery.
11. Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
12. Patients participated other subjects 3 months before this subject.
13. Sponsors or researchers directly involved in the testing or their family members.