cyrilzakka/clinical-trials huggingface dataset:
Quit Smoking Text Message Study

This project will address research gaps and advance the science of smoking cessation by conducting a randomized controlled trial of an evidence-based, population-level quit smoking text messaging program with or without a smartband.

Aim 1 of this study is to test within-treatment effects for smoking cessation. The primary outcome will be biochemically (cotinine)-confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks). Secondary outcomes will be percent days smoke-free, time to relapse, and rated treatment satisfaction.

Aim 2 of this study is to explore sex/gender differences in treatment effects for smoking cessation. Given established sex/gender differences in smoking behavior and cessation,randomization will be stratified by sex/gender and we will measure effects of sex/gender on outcomes. Effect sizes will be estimated for smoking outcomes by sex.

Outcomes will be evaluated for those who complete enrollment, defined as those who complete study onboarding.

Eligibility Criteria:
Inclusion Criteria:

* daily smokers for at least 6 months
* report an interest in quitting smoking.

Exclusion Criteria:

* reporting being currently enrolled in another quit smoking program
Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, under single-dose and steady-state conditions in male subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male and are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
* Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results

Exclusion Criteria:

* History of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
* Participation in any other trials involving investigational products within 3 months preceding the start of dosing
Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease.

Lumbar discectomy and injection of purified cellular bone marrow concentrate or lumbar discectomy only

In order to find a regenerative treatment for back pain from DDD, cell based therapies have become of increasing interest. Recent clinical studies have shown promising improvement in pain and disc hydration, thus indicating a regenerative effect.

The use of mesenchymal stem cells for regeneration of degenerated connective tissue of mesenchymal origin has proven efficient in multiple recent studies. However, the acquisition of mesenchymal stem cells (MSC) is always an extensive procedure requiring either enzymatic or genetic manipulation of acquired tissues. Thus, the use of these MSCs is highly controversial and raises concerns in terms of patient safety.

One of the most commonly used sources for MSCs is bone marrow tissue. Even when not manipulated, these tissues already contain a significant amount of mesenchymal stem cells and growth factors. Therefore, they are used for regenerative treatments of multiple degenerative musculoskeletal diseases.

This is an exploratory pilot study which aims to compare patient outcomes between two treatments approaches for DDD that are currently being used in clinic. While micro- discectomy is the standard of care for DDD, micro-discectomies with autologous bone marrow cell injections have been used in clinic in the past year. The goal of this study is to determine if the bone marrow injection group is superior compared to the control group (state of the art micro-discectomies) in enhancing degenerative disc recovery and improving or preventing back pain.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥18 years of age
2. Radiologically (MRI) confirmed diagnosis degenerative disc disease of the lumbar spine and/or lumbar disc herniation
3. Unresponsive to conservative/non-operative treatment for \>3 months
4. Psychosocial, mental and physical ability to understand and to adhere to this protocol, especially adhering to the visit schedule follow-ups, and observe treatment plan
5. Signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial study-related procedures

Exclusion Criteria:

1. Pregnant or breastfeeding patients
2. Active malignancy
3. Active chronic or acute infection
4. Autoimmune disorder that impacts the lumbar spine (Ankylosing spondylitis, lupus eg.)
5. Acute Episode or major mental illness
6. Major cognitive impairment causing to inability to understand informed consent
A Study in Taiwan Based on Medical Records That Looks at the Occurrence of Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Started LABA/LAMA or LAMA Treatment

Study to collect the data on Chronic Obstructive Pulmonary Disease (COPD) patients who were administered with Long-Acting Beta-Agonist/ Long-Acting Muscarinic Antagonist (LABA/LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment


Eligibility Criteria:
Inclusion Criteria:

Patients who fulfil ALL the following criteria are included.

1. Patients who diagnosed with COPD who were prescribed with LABA/LABA (FDC or free combo) as a new initiation or switching from other therapy (i.e., single/dual/triple), or newly receiving LAMA treatment for 3 months at least prior to 30 June 2018
2. Male or female patients ≥ 40 years of age

Exclusion Criteria:

1. Patients who meet the following criterion are not included.

* Patients with documented diagnosis of bronchial asthma, asthma-COPD overlap syndrome (ACOS), bronchiectasis, cystic fibrosis, or lung cancer
Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography (PET) Scan in Hodgkin's Lymphoma

The primary objective of the study is to determine the progression-free survival \[PFS\] at 36 months for patients with Hodgkin lymphoma who achieve a complete metabolic response as demonstrated by a negative fluorodeoxyglucose (FDG)-PET scan after one cycle of ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) who undergo abbreviated ABVD chemotherapy (3 cycles).

The proposed study is based on the repeated demonstration that patients with Hodgkin lymphoma who attain a negative PET scan early in therapy (after one or 2 cycles of chemotherapy) have a uniformly excellent outcome, with long term disease free survival of 90-95%. We propose to abbreviate chemotherapy in those patients showing a complete metabolic response as measured by FDG-PET after one cycle of ABVD. These patients will undergo two more cycles of ABVD chemotherapy, for a total of 3 cycles. Those patients failing to achieve a complete metabolic response as demonstrated by residual FDG avidity will go off study and be treated as per their primary treating physician.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented classical Hodgkin lymphoma according to the WHO Classification. Nodular lymphocyte predominant Hodgkin lymphoma is excluded
* No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma
* Measurable disease must be present either on physical examination or imaging studies. Any tumor mass measurable in two dimensions and \> 2 cm is acceptable (or 1.5 cm if 0.5 cm slices are used as in spiral CT scans)
* Age ≥ 18
* Patients must have at least one hypermetabolic lesion identifiable on initial PET scan
* LVEF by ECHO or MUGA within institutional normal limits
* Initial laboratory data should be compatible with the administration of standard doses of ABVD chemotherapy

Exclusion Criteria:

* Patient has no known HIV infection
* Patient is non-pregnant and non-lactating. Due to the teratogenic potential of the agents used in this study, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control
* No other history of lymphoproliferative disorder or granulomatous disease
To Evaluate the Effect of MCS® in Prostate Cancer Prevention

To evaluate the effect of MCS® compared with placebo in reducing the risk of biopsy-detectable prostate cancer in high-risk subjects after 104 weeks (24 months) of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. high-risk subjects of prostate cancer.
2. Male subject with age from 50 to 75 years old.
3. Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF).

Exclusion Criteria:

1. Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function.
2. Subjects with a PSA \> 10.0 ng/ml.
3. Subjects with a history of prostate cancer.
4. Subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period.
5. Subjects are considered ineligible for the study as judged by the investigator.
Neoadjuvant Epirubicin, Cisplatin and Capecitabine (ECX) Followed by Definitive Chemoradiation With/Without Surgery for Squamous Cell Carcinoma of the Oesophagus

This is a study to investigate the efficacy and safety of epirubicin, cisplatin and capecitabine (ECX) as neoadjuvant therapy prior to radical chemoradiotherapy using capecitabine and cisplatin as radio-sensitisers in patients with newly diagnosed localized squamous cell carcinoma of the oesophagus.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Histologically verified squamous cell carcinoma of the cervical or thoracic oesophagus
* American Joint Committee on Cancer (AJCC) Stage I-III (T1-3 N0-1 M0) (33), as assessed by spiral or multi-slice computed tomography (CT) and endoscopic ultrasound, where radical chemoradiation would be considered with curative intent.
* No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication.
* World Health Organization (WHO) performance status 0,1 or 2.
* Adequate bone marrow function with platelets \> 100 x 10\^9/l; white blood cells (WBC) \> 3 x 10\^9/l; neutrophils \> 1.5 x 10\^9/l at the time of study entry.
* Serum bilirubin \< 35 micromol/l.
* Serum creatinine \< 180 micromol/l and measured creatinine clearance over 60 ml/min.
* No concurrent uncontrolled medical condition.
* No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 10 years.
* Life expectancy \> 3 months.
* Adequate contraceptive precautions if relevant.
* Informed written consent.

Exclusion Criteria:

* The presence of locally advanced or metastatic disease precluding curative chemoradiation (T4 or Stage IV or M1a-b) or disease not encompassable in a radical radiotherapy field.
* Total dysphagia (O'Rourke's swallowing function scoring system 5) precluding swallowing of capecitabine even when crushed.
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* Intracerebral metastases or meningeal carcinomatosis.
* New York Heart Association classification Grade III or IV.
* Uncontrolled angina pectoris.
* Pregnancy or breast feeding.
* Impaired renal function with measured creatinine clearance less than 60 ml/min.
* Previous investigational study drug
* Known malabsorption syndromes
* Patients with a known hypersensitivity to fluorouracil (5-FU) or with a dihydropyrimidine dehydrogenase (DPD) deficiency
* Hearing loss
Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy

The goal of this study is to characterize the function and efficacy of the bioactive nutrient, vitamin D, in relation to infection and inflammatory status across pregnancy. The three specific aims of this study are 1) To address the impact of maternal vitamin D status on inflammation and infections across pregnancy using retrospective data, 2) To address the impact of vitamin D supplementation on maternal vitamin D status, inflammation and infections across pregnancy using prospective data and 3) To assess the impact of maternal vitamin D status during pregnancy on inflammatory mediators at the level of the placenta.

Archived serum collected from 158 adolescents at mid-gestation (approximately 26 weeks) and delivery will be analyzed for inflammatory cytokines. The impact of these inflammatory markers will be assessed by comparing the data to measures of vitamin D (25(OH)D, calcitriol and parathyroid hormone) and infections and inflammatory complications abstracted from medical charts. Placental samples were collected from a subset (n=132) of these pregnant teens and these tissues will be analyzed using genome wide microarray of messenger ribonucleic acid (mRNA) and microRNA (miRNA) related to inflammatory processes. A separate group of pregnant adolescents (n=140) will be recruited at entry into prenatal care for a vitamin D supplementation trial. Teens will be randomly assigned to one of two supplements (200 IU D3/d vs. 2000 IU D3/d). Similar to the retrospective analysis, maternal calciotropic hormones and inflammatory cytokines will be assessed at entry into the study, mid-gestation (23-28 weeks) and at delivery. Inflammatory processes and infections reported across pregnancy will be evaluated in relation to vitamin D status and inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Female adolescents between 13 and 18 years of age
* Between 12 and \< 30 weeks pregnant

Exclusion Criteria:

* HIV-infection
* Eating disorders
* Malabsorption diseases
* Diabetes mellitus
* Gestational diabetes
* Pregnancy induced hypertension or elevated diastolic blood pressure (\>110)
* Steroid use
* Substance abuse history
* Taking medications known to influence Ca or vitamin D status
* Diagnosis of elevated blood lead concentrations during childhood
* Smokes tobacco
FSTL1 and PPCs on Pediatric Within LDLT:a Prospective Cohort Analysis

The goal of this observational study is to identify the association between FSTL1 elevation and acute lung injury (ALI) after pediatric liver transplantation.The main questions it aims to answer what the risk factors are for ALI in children and to evaluate the predictive value for the development of ALI.Participants will be divided into non-ALI group and ALI group according to whether they had ALI in a week after liver transplantation.Researchers will compare the difference between the two groups and use multivariate logistic regression analysis to screen the risk factors of ALI, and receiver operating characteristic(ROC) curve was used to evaluate the predictive efficacy of risk factors.

Postoperative pulmonary complications(PPC) are complicated diseases with high morbidity and mortality for pediatric after living donor liver transplant (LDLT), Acute lung injury(ALI) after LDLT is a common and complex pulmonary complication, it is leading causes of disability and death,both in the acute and long-term postoperative period, the identification of effective prediction model involved in ALI is urgent and highly demanded.In order to observe the effect of follistim like protein 1(FSTL1) on the incidence of ALI who underwent LDLT, and explore the related mechanism, the investigators aim to collect more than 400 infant patients underwent LDLT from May 2023 to December 2023 in our single-center prospective study. Basic clinical data of children were recorded, including age, gender, alanine aminotransferase (ALT), aspartate aminotransferase (AST), International Normalized ratio (INR), childhood end-stage liver disease score (PELD) and other indicators.The expression levels of serum FSTL1 were recorded immediately after induction of anesthesia (T1), 10 minutes at anhepatic stage (T2), 30 minutes at new hepatic stage (T3) and immediately after abdominal closure (T4). Murray score was used to determine whether ALI occurred one week after LDLT, and the children were divided into non-ALI group and ALI group. Postoperative mechanical ventilation time, ICU stay time, total length of hospital stay and mortality during hospitalization are recorded.

The primary outcome utilised a regression approach to adjust for potential confounders associated with ALI and FSTL1. Multivariate logistic regression analysis was used to screen the risk factors of ALI, and ROC curve was used to evaluate the predictive efficacy of risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Patient was diagnosed with biliary atresia
* American society of anesthesiologists physical status Ⅱ-Ⅲ

Exclusion Criteria:

* Secondary liver transplantation or other important organ injury before surgery
* Present with congenital airway or respiratory malformation
* Acute respiratory infection or respiratory insufficiency was present within 1 month before surgery
Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19

This trial will study the use of USB002 given as an intravenous infusion in patients with respiratory distress due to infection with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent from patient or legal representative;
2. Age 18 or greater;
3. Positive reverse transcription polymerase chain reaction (RT-PCR) for SARS-CoV-2 (≤10 days);
4. Respiratory rate \> 20 RR;
5. SpO2 \< 94% on room air, requiring supplemental oxygen, requiring invasive mechanical ventilation, or requiring ECMO;
6. Chest X-ray confirming bilateral pulmonary infiltrates;
7. Body mass index of ≤ 40 units/kg/m2;
8. Adequate method of birth control.

Exclusion Criteria:

1. Terminally ill patients due to underlying cardiac, cancer or severe debilitating neurological disease including coma;
2. Hospitalization expected to be \< 96 hours due to medical improvement;
3. Interstitial lung disease;
4. Correction of QTc values obtained by 12 lead EKG using Fredericia's formula (QTcF) \> 450 ms;
5. History of hypotension (mean arterial blood pressure \< 65 mmHg), unrelated to CoVID-19 infection;
6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times upper limit of normal;
7. Participating concurrently on another clinical trial for the experimental treatment of COVID-19;
8. Active chemotherapy use;
9. Pregnant and/or lactating women.
Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK

This study is to investigate the pharmacokinetic (PK) and safety of M2951 (Bruton's tyrosine kinase \[BTK\] inhibitor) in participants with different degrees of hepatic impairment compared to participants with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Participants with normal hepatic function only will be overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion OR
* Participants with moderately impaired hepatic function only will be considered to have moderately (Child-Pugh class B and confirmed liver cirrhosis) impaired hepatic function and has been clinically stable for at least 1 month prior to Screening OR
* Participants with mildly impaired hepatic function only will be considered to have mildly (Child-Pugh class A and confirmed liver cirrhosis) impaired hepatic function and has been clinically stable for at least 1 month prior to Screening
* Have a body weight within 50.0 and 120.0 kilogram (kg) and body mass index (BMI) within the range 19.0 and 36.0 kilogram per square meter (kg/m\^2)
* Female participants are not pregnant or breastfeeding, and at least one of the following conditions applies
* Not a woman of childbearing potential (WOCBP)
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Clinical history of autoimmune disorder with hepatic influence (Hashimoto thyroiditis and rheumatic diseases allowed)
* History of any malignancy
* Diseases and surgeries of the gastrointestinal tract, which could influence the gastrointestinal anatomy and mobility. Prior history of cholecystectomy or inflammatory bowel disease, and any clinically relevant surgery within 6 months prior to Screening
* History of chronic or recurrent acute infection or any bacterial, viral, parasitic or fungal infections within 30 days prior to Screening and at any time between Screening and admission, or hospitalization due to infection within 6 months prior to Screening
* History of shingles within 12 months prior to Screening
* History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the trial per the Investigator's discretion
* Participants with impaired hepatic function will be excluded who had Primary and secondary biliary cirrhosis.
* Participants with impaired hepatic function will be excluded with Clinical evidence of severe ascites.
* Participants with impaired hepatic function will be excluded with Hepatic encephalopathy Grade greater than 1
* Other protocol defined exclusion criteria could apply
THE FACTORS AFFECTING THE ADHERENCE TO THE PULMONARY REHABILITATION PROGRAM IN COPD

Investigators will compare the factors affecting the adherence to the outpatient pulmonary rehabilitation program in COPD patients

Patients were referred to the Pulmonary Rehabilitation Unit and were recommended to participate in the exercise program by a team of experts included in this study.

Demographic and clinical characteristics of patients were recorded before the pulmonary rehabilitation program. All cases were evaluated by pulmonary function test, arterial blood gas analysis, six minute walking test, MMRC Dyspnea Scale. Causes that prevented program adaptation of those who did not participate in the program or who left the program were questioned. Patients completing the eight-week PR program will compare with those who did not complete the program or who did not start the program at the recommended time.

Eligibility Criteria:
Inclusion Criteria: COPD Patients referred to the outpatient pulmonary rehabilitation unit -

Exclusion Criteria: To be unvolunteer

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