cyrilzakka/clinical-trials huggingface dataset:
Single Arm, Open Label Trial With Iptacopan Treatment for 24 Weeks, in Patients on Stable Regimen of Anti-C5 Who Switch to Iptacopan.

The purpose of the study is to find out if iptacopan is effective and safe in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who switch from their current standard of care treatment (eculizumab or ravulizumab) to study treatment, iptacopan/LNP023.

This is a multicenter, single-arm, open label trial, with iptacopan treatment for 24 weeks in adult PNH patients.

This study is comprised of two periods:

* A Screening period lasting up to 8 weeks.
* A 24-week open-label, iptacopan Treatment period.

After completion of the treatment period, participants who continue to benefit from the iptacopan treatment based on the study doctor's evaluation will be able to join the Roll-over extension study.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent must be obtained prior to participation in the study.
* Male and female participants ≥ 18 years of age, at the time of ICF signatures and with a diagnosis of PNH confirmed by treating physician.
* Stable regimen (dose and intervals) of anti-C5 antibody treatment (either eculizumab or ravulizumab) for at least 6 months prior to screening
* Mean hemoglobin level ≥10 g/dL
* Vaccination against Neisseria meningitidis and S. pneumoniae infection are required prior to the start of iptacopan treatment.
* If not received previously, vaccination against Haemophilus influenzae infections is recommended, if available and according to local regulations.
* Ability to communicate well with the investigator, to understand and comply with the requirements of the study
* Other protocol -defined inclusion criteria may apply at the end.

Exclusion Criteria:

* Participation in any other investigational drug trial or use of other investigational drugs at the time of enrollment
* Patients requiring red blood cell transfusion in the 6 months prior to screening or during screening
* History of stem cell transplantation or any solid organ transplantation
* Active systemic bacterial, viral (incl. COVID-19) or fungal infection within 14 days prior to study drug administration
* Presence of fever ≥ 38.0 °C (100.4 °F) within 7 days prior to study drug administration
* Human immunodeficiency virus (HIV) infection (known history of HIV or test positive for HIV antibody at Screening)
* A history of recurrent invasive infections caused by encapsulated organisms, e.g. meningococcus or pneumococcus
* Unstable medical condition including, but not limited to, myocardial ischemia, active gastrointestinal bleeding, coexisting chronic anemia unrelated to PNH, or unstable thrombotic event not amenable to active treatment as judged by the investigator at Screening.
* History of cancer of any part of the body within the past 5 years,
* Ongoing drug or alcohol abuse that could interfere with patient's participation in the trial.
* Any medical condition deemed likely to interfere with the patient's participation in the study
* Female patients who are pregnant or breastfeeding, or intending to conceive during the course of the study
Effect of Early Treatment With Sivelestat Sodium in ARDS Patients

This study is a multicenter, prospective, observational cohort study. The subjects were patients who developed ARDS within the preceding 72h. They were divided into 2 groups based on the use of sivelestat sodium which was determined by the physician in charge based on the condition of the patients: sivelestat sodium group and conventional treatment group. 560 patients were planned to be enrolled, with 280 patients in each group. In the sivelestat sodium group, patients were treated with sivelestat sodium within 72h of the diagnosis of ARDS. After 5 days of sivelestat treatment, sivelestat treatment should be stopped if the oxygenation index is greater than 300mmHg for at least 3 consecutive times; otherwise, sivelestat treatment should be continued until the oxygenation index is greater than 300mmHg for at least 3 consecutive times; if sivelestat treatment is continued until the 14th day, the drug should be stopped regardless of the oxygenation situation. Baseline data and Murray lung injury score, inflammatory markers, routine test results, duration of ECMO use/length of hospital stay/length of ICU stay were recorded at 1, 3,5, and 7 days after patients were enrolled, and patients were followed up on the 28th and 90th days.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed informed consent;
* ≥18 years old;
* Patients developed ARDS in the preceding 72h;
* The total scores of the Murray lung injury scores were greater than 6 （When lung compliance was not measured, the total scores of the other three scores were greater than 4）;

Exclusion Criteria:

* Pregnancy or lactation;
* ARDS was diagnosed for more than 72 hours;
* Sivelestat sodium was used for treatment prior to enrollment;
* Patients with more than 3 extra-pulmonary organ injuries/failure;
* Severe chronic liver disease (Child-pugh grade C);
* Previous history of allergy to sivelestat sodium or any of its ingredients or preservatives;
* Patients whose primary disease cannot be effectively controlled;
* Patients judged by the investigator to be unsuitable for participation in this study.
Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)

This randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a TVT Secur or a standard TVT surgical procedure. The main outcome is effectiveness of the procedure, determined using a 1-hour pad test (which tests for urine leakage) 12 months after surgery. The study will be carried out in 4 to 6 centers and will involve urogynaecologists, urologists and general obstetrician-gynaecologists: all clinicians will have received adequate training.


Eligibility Criteria:
Inclusion Criteria:

* Women with stress incontinence, defined as leaking with increased abdominal pressure
* Eligible for both types of surgery

Exclusion Criteria:

Women who:

* Have vaginal prolapse requiring surgical repair
* Have had previous incontinence surgery
* Have overactive bladder or incontinence is caused only by bladder overflow
* Intend to have further children
* Have Alzheimer's or Parkinson's disease, progressive neurological disease such as multiple sclerosis, or are immunocompromised
* Are unable to understand English
* Will be unavailable for follow-up
The Role of TCM on ERAS of Rectal Cancer Patients

This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.

The hypothesis is that TCM can decrease the postoperative complications for rectal cancer. So the study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients. Patients enrolled in this study will be randomized into two groups with TCM intervention or placebo. The intervention will be described below. Primary endpoint is postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Signed written consent form;
* Age from 18 to 75 years old;
* Pathological diagnosis as rectal adenocarcinoma;
* undergo laparoscopic curative surgery;
* Patients' TCM syndrome accords with thoses of spleen deficiency syndrome;

Exclusion Criteria:

* Patients undergo non-curative surgeries;
* Participants with skin allergy, skin ulceration and diabetes mellitus with poor glycemic control;
* Participants with severe dysfunction of heart, liver and kidney, who could not receive TCM treatment;
* Women who are pregnant or breastfeeding;
* Participants have mental illness or have difficulty in language communication and are unable to complete the study;
* Participants could not cooperate with this researcher for other reasons.
Urine and Ultrasound Screening for Kidney Disease in Children

The aim of this study is to early detect kidney disease in the natural population cohort of children by urine and ultrasound screening, to assist in the precise prevention and treatment of children's kidney disease, and to establish a risk prediction system for children's kidney disease. About 10,000 children called KunQi Cohort are born in Jiangsu Province(8,000 in Kunshan and 2,000 in Qidong) and about 3,000 born in Shanghai. Through the project, child who is found with abnormal urine or ultrasound result will be referred to Children's Hospital of Fudan University to get further examination and treatment.

Chronic kidney disease (CKD) often has an insidious onset. Early detection of CKD and more aggressive treatment and monitoring of high-risk CKD patients at risk of progression are the consensus of current medical practice. However, there is currently no CKD risk prediction system for the Chinese population, especially children. The main goal of this project is to establish a risk prediction system for children's kidney disease, and to assist in the precise prevention and treatment of children's kidney disease. The project is based on the "urine and ultrasound screening" strategy that has been carried out for more than ten years in Shanghai, using a non-invasive and effective screening method in the natural population cohort of children, in order to detect kidney disease in the early stage.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive live newborn infants(regardless of physical condition)
* Complete at least 3 years of follow-up

Exclusion Criteria:

* Declining the screening
* Missing
Ultrasound in Evaluation of Preoperative Fluid Management of Hip Fracture Surgery Patients

Goal directed fluid therapy is a new standard surgical procedure which is successful in patients undergoing hip revision arthroplasty, There has been a reduction of postoperative complications, most importantly surgery with a decrease inbleeding, as well as in hospital and intensive care stays it is related. The aim of this study is to evaluate effectiveness of pulmonary ultrasound score and vena cava collapse index measurements in the patients undergoing hip surgery under spinal anesthesia and relation with peroperative fluid management.

Patients who will undergo hip surgery under spinal anesthesia using the closed envelope method it will be randomized and divided into 2 groups.

1.The inferior vena cava collapse index IVC CI and lung ultrasound score (LUS) measurements and goal directed fluid therapy will be done 2. Group applying zero balance liquid therapy to patients with conventional methods is planned.

1. Patients in the group will be started with fluid replasment at an hourly rate of 2ml/kg/h and with ultrasound measurement the infused fluid will be evaluated and regulated.
2. Crystalloid liquid infusion at a rate of 2ml/kg/hour will be administered to the patients in the group additional fluid replacement will be decided by monitoring bleeding and urinary output, zero balance is aimed at patients. Both groups were treated with spinal anesthesia in the postoperative period 120. minute IVC CI and the LUS score value will be checked.

If the CI is below 50% and the LUS score is below 15, fluid management will be considered as successful.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 65 who will undergo hip surgery
* ASA I-II-III patients

Exclusion Criteria:

* Patients under the age of 65
* Patients with ASA IV-V
* Patients with BMI\>above 35
* Patients with an Lus score of 15 and above
* Patients who have not undergone spinal anesthesia
A Single-Arm, Expanded Access Study of Zanubrutinib in Participants With B-cell Malignancies

This is a multicenter expanded access study of zanubrutinib monotherapy for participants with B-cell malignancies who are ineligible to enroll into any available zanubrutinib clinical trials


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically confirmed diagnosis of WM with R/R disease or treatment-naive and considered by their treating physician to be unsuitable for standard chemoimmunotherapy regimens
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
3. Absolute neutrophil count (ANC) ≥ 0.75 x 109/L, independent of growth factor support; and Platelet count ≥ 50 x 109/L, independent of growth factor support or transfusion within 7 days of study entry
4. Creatinine clearance of ≥ 30 mL/min
5. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x upper limit of normal (ULN)
6. Total bilirubin level ≤ 2 x ULN (unless documented Gilbert's syndrome)

Key Exclusion Criteria:

1. Prior exposure to a Bruton tyrosine kinase (BTK) inhibitor
2. Evidence of disease transformation at the time of study entry
3. Ongoing requirement for systemic corticosteroid other than systemic adrenal replacement therapy
4. Chemotherapy given with antineoplastic intent, targeted therapy, radiation therapy or antibody-based therapy within 4 weeks of the start of study drug
5. Ongoing toxicity of ≥ Grade 2 from prior anticancer therapy
6. Prior or concurrent active malignancy within the past 2 years
7. Clinically significant cardiovascular disease
8. Unable to swallow capsules or disease significantly affecting gastrointestinal function
9. Active fungal, bacterial and/or viral infection requiring systemic therapy
10. Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows
11. Pregnant or lactating women
12. History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
13. History of severe bleeding disorder
14. Active central nervous system (CNS) involvement by WM and/or lymphoma

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study

This prospective, single-arm, open-label feasibility study will assess the safety, tolerability, and effectiveness of repetitive transcranial magnetic stimulation (rTMS) in patients with major depression (MDD) to test the hypothesis that remission rates can be increased by additional treatment sessions.


Eligibility Criteria:
Inclusion Criteria:

* are outpatients
* are voluntary and competent to consent to treatment
* are between the ages of 18 and 85, inclusive
* are able to adhere to the treatment schedule
* pass the TMS safety-screening questionnaire
* have had no change or initiation of any psychotropic medication in the 4 weeks prior to screening

Exclusion Criteria:

* previous rTMS treatment
* have a history of substance dependence or abuse within the last 3 months
* have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
* have active suicidal intent
* have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
* have a diagnosis of any psychotic disorder
* have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure confirmed diagnostically by neurological assessment (except those therapeutically induced by ECT), cerebral aneurysm, Parkinson's disease, Huntington's chorea, dementia, stroke, neurologically confirmed diagnosis of traumatic brain injury, or multiple sclerosis.
* if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
* clinically significant laboratory abnormality, in the opinion of the investigator
* currently (or in the last 4 weeks) take more than lorazepam 4 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
* non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
* any significant cardiovascular or metabolic disorder or insult including, but not limited to: coronary artery disease, abnormal heart rhythms, heart failure, cardiac valve disease, congenital heart disease, cardiomyopathy, vascular disease, dyslipidemia, diabetes, or hypertension
A Short Period of Proactive Community Case Management (ProCCM) to Improve Early Care-seeking for Fever in Sierra Leone

This is a three arm cluster randomized control trial to determine if proactive community case management (ProCCM) conducted over a short period of time improves care-seeking indicators for febrile illnesses in children in hard to reach (HTR) areas of Sierra Leone compared to integrated community case management (iCCM). The three arms include:

1. Optimized standard of care for CCM plus ProCCM - ProCCM will be implemented for two months near the start of the transmission season, and the existing program will be supplemented to ensure that HTR CHWs have all commodities needed for malaria testing and treatment and are adequately trained on SBCC messages to ensure activities are implemented as designed.
2. Optimized standard of care- as in arm 1 without ProCCM
3. Routine implementation (control) - no changes (business as usual) to iCCM, SBCC and stock management.


Eligibility Criteria:
Inclusion Criteria:

* Household lives within the study cluster
* Head of household or a household member over the age of 18 provides verbal consent for the HTR CHW visit
* All available household members at the time of the HTR CHW visits are eligible to receive services

Exclusion Criteria:

* Household does not live within the study cluster
* Household does not provide consent for the study visit
Evaluation of Antimicrobial, Post Operative Pain of Cinnamon Extract Versus Sodium Hypochlorite Irrigant Following Pulpectomy of Primary Teeth

The aim of the study is to evaluate effectiveness of cinnamon extract versus sodium hypochlorite as root canal irrigant for in pulpectomy of primary teeth in reduction of bacterial count .

Preservation of primary teeth with non-vital pulp is a major problem in pediatric dentistry, as it is a poly-microbial and dominated by obligatory anaerobic bacteria. Regarding these case preferable treatment modality is pulpectomy . The objective of pulpectomy is complete removal of necrotic and irreversibly infected pulp of an affected tooth but due to limited ability of mechanical preparation to eliminate entrapped micro-organisms in the canal space owing to the tortuous and complex nature of the root canal system .Thus, the use of antimicrobial agents has been recommended as an adjunct to mechanical instrumentation in deciduous teeth . Due to potential side effects, safety concerns of synthetic drugs and cytotoxic reactions of commercial intra canal irrigants and their limited ability to eliminate bacteria from dentinal tubules . Finding the best irrigating solution for endodontic therapy in primary and permanent teeth is still a working progress .There is a growing interest in using sustainable products of natural origin as an alternative to commercially available industrial ones .Cinnamon , which has gained popularity in recent time due its antibacterial , antifungal , anti-inflammatory \& antiseptic activity . It has shown effectiveness against S. mutans and E. fecalis organisms . It is also known to show a wide spectrum of action on gram positive and gram negative bacteria .

Eligibility Criteria:
Inclusion Criteria:

* Children:

  1. Aged 4 to 8, in good general health, and medically free.
  2. Cooperative patients who will comply to dental treatment .
  3. Parents provided with written informed consent.
  4. No previous history of antibiotics administration or last dose was taken from at least 2 weeks.
* Teeth:

  1. Carious primary molars with irreversible pulpitis.
  2. Presence of localized swelling ,sinus and pain on percussion which indicate non vital pulp .
  3. Presence of periapical and furcation radiolucency .
  4. In periapical radiograph teeth have no more than 1/3 of root resorption.

Exclusion Criteria:

* Children:

  1. Children with medical, physical, or mental conditions.
  2. Severly Uncooperative children .
* Teeth:

  1. Primary molars with any congenital anomalies.
  2. Teeth with un-restorable crowns .
  3. Root resorbtion more than half of the root.

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Homologous Recombination Deficiency Status in Epithelial Ovarian Cancer

The homologous recombination deficiency (HRD) status in Chinese population with epithelial ovarian cancer (EOC) is little known. This study would recruit 1300 Chinese EOC patients. A multi-panel testing of 36 genes would be given for these patients in their peripheral blood and tumor tissues. These 36 genes include: BRCA1, BRCA2, ABRAXAS1(FAM175A）, ATM, ATR, BAP1, BARD1, BRIP1, C11ORF30（EMSY）, CDK12, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCI, FANCL, MRE11A, NBN, PALB2, PPP2R2A, PTEN, RAD50, RAD51B, RAD51C, RAD51D, RAD54B, RAD54, MLH1, MSH2, MSH6, PMS2, EPCAM, STK11, TP53, CDH1. The study would select 150 patients with pathogenic or likely pathogenic mutations in BRCA1/2 and 150 patients without these mutations to further explore the HRD status. The HRD model is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Pathological confirmation of epithelial ovarian cancer
* With available tumor tissues
* Given consents to participate the study

Exclusion Criteria:

* Not meeting all of the inclusion criteria
Clinical Trial of Electroacupuncture Stimulation on Prevention and Treatment of Oxaliplatin Neurotoxicity

The clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives electroacupuncture in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.

The clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives electroacupuncture in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.Mainly to study about oxaliplatin into electroacupuncture leads to the influence of the peripheral nerve toxicity.Other clinical evaluation includes chemotherapy drug toxicities,quality of life(QOL), etc.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-80 ;
2. male and female ;
3. signed the informed consent form;
4. Eastern Cooperative oncology Group(ECOG)O-2,life expectancy more than 3 months;
5. Indication for Chemotherapy,no contraindication;
6. First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy;
7. At least 8 weeks after last biotherapy;
8. Surgery:had not received transplantation surgery,at least 2 weeks after last major surgery.

Exclusion Criteria:

1. Chemotherapy is contraindicated;
2. Having the primary disease can cause the neuropathy;
3. A history of other malignant tumor in recent 5 years;
4. Less than 6 months after last chemotherapy or radiotherapy;
5. Less than 8 weeks after last biotherapy;
6. Being afraid of acupuncture seriously;
7. Had received transplantation surgery,less than 2 weeks after last major surgery;
8. Other researchers think is not suitable for this clinical trail.