cyrilzakka/clinical-trials huggingface dataset:
Triple Artemisinin-based Combination Therapy for Delaying Drug Resistance Development - a Randomized Clinical Trial

Background: Artemisinin resistance has emerged in parts of Southeast Asia, and there are reports in Africa of reduced susceptibility of Plasmodium falciparum parasites against artemisinin-based combination therapy (ACT). No new drugs are available in the pipeline to replace ACTs in case they fail.

This study aims to assess whether a sequential administration of triple ACTs with different partner-drugs can improve the efficacy of ACT for treatment of uncomplicated malaria.

Methods: A health facility-based, three-arm partially blinded randomized clinical trial will be conducted to assess efficacy and safety of a sequential administration of artemether-lumefantrine followed immediately by artesunate-amodiaquine (AL+ASAQ) or artemether-lumefantrine with by amodiaquine (AL+AQ) compared to artemether-lumefantrine plus placebo (AL+PBO). Eligible children aged 6 - 120 months and with microscopy confirmed uncomplicated P. falciparum malaria will be enrolled, administered with trial medicines and followed-up at 0 (just prior to first drug intake) and 8 hours on day 0, 12 hourly on days 1, 2, 3, 4, 5, followed by once daily on days 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28, 35, 42 and 56 for clinical and laboratory evaluations. Clinical evaluation will involve assessment of signs and symptoms related to the disease and or trial medicine during follow-up. Laboratory evaluation will include microscopic determination of presence of malaria parasites and species, hemoglobin level, molecular analysis for markers of drug resistance and to differentiate recrudescence from new infection. The primary outcome will be Polymerase Chain Reaction (PCR)-adjusted adequate clinical and parasitological cure rate on days 28 and 42.

Expected outcomes: The findings will give an insight on whether 3 ACTs are more efficacious than the use of first-line regimen alone, and are tolerable for treatment of uncomplicated falciparum malaria.


Eligibility Criteria:
Patients presenting at the health facility with suspected acute uncomplicated malaria will be screened for eligibility.

Inclusion Criteria:

* Age from 6 - 120 months
* Weight ≥ 5 kg
* Body temperature ≥37.5°C or history of fever in the last 24 hours
* Microscopy confirmed P. falciparum mono-infection
* Parasitemia level of 1000-200000/μL
* Ability to swallow oral medication
* Ability and willingness to abide by the study protocol and the stipulated follow-up visits
* A written proxy informed consent from a parent/guardian

Exclusion Criteria:

* Children aged below 6 months will not be included in the study because ACTs are contraindicated in this group.
* Evidence of severe malaria or danger signs
* Known allergy to trial medicines
* Reported antimalarial intake ≤2 weeks
* Haemoglobin \<5 g/dL
* Blood transfusion within last 90 days
* Febrile condition other than malaria
* Known underlying chronic or severe disease (including severe malnutrition).
Arterial and End-Tidal CO2 Gradient as a Mortality Predictor in Critical Care Patients

Scoring systems (SOFA, APACHE-II etc.) are used to estimate the mortality rates of patients treated in the intensive care unit. . In the scoring systems used, the disfunction level of the organs of the patients is measured. Blood gas analysis is routinely performed in patients whom intubated in the intensive care unit and receiving mechanical ventilation support, and the patient's treatment is optimized according to the results of the examination. The patient's mechanical ventilation settings are regulated by analyzing the Partial Arterial Carbondioxide (paCO2) value in the patient's blood gas result. The difference between the paCO2 value in the blood gas and the End-tidal Carbondioxide (EtCO2) value measured in the mechanical ventilator is 3-5mmHg in normal healthy people, while this difference is seen more in critical care patients. In critically ill patients in the intensive care unit, there is a greater increase in the difference between paCO2 and ETCO2 in cases where mortality is high, such as global perfusion disorder, shock situations, and massive pulmonary embolism, etc. In this study, it was planned to investigate the use of the difference between the paCO2 value in the blood gas taken from the patient and the ETCO2 value measured in the mechanical ventilator to predict the mortality rate of the patient.


Eligibility Criteria:
Inclusion Criteria:

* Critical Care Patients intubated in last 24 hours.

Exclusion Criteria:

* Patients younger than 18 years old.
A Multi-Omics Study of Vasospastic Angina

This is a observational study to identify the key factor associated with vasospastic angina and to explore the prognosis of the participants. The study will recruit 400 patients with vasospastic angina, 400 healthy controls and 400 patients with acute myocardial infarction. Next generation sequencing, metabolome and proteomics will be performed in these participants.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* diagnosed as vasospastic angina

Exclusion Criteria:

* participate in any drug clinical trials within 3 months
* patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years
* serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients)
* previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix)
The Effect of Postoperative Referred Pain in the Left Shoulder on Short-term Outcomes for Laparoscopic Gastrectomy

The purpose of this study is to explore the effect of postoperative referred pain in the left shoulder on short-term outcomes for laparoscopic gastrectomy

A prospective cohort study will be performed to explore the effect of postoperative referred pain in the left shoulder on short-term outcomes for laparoscopic（including robot assisted laparoscopic surgery） gastrectomy .The evaluation parameters are overall postoperative morbidity rates,perioperative clinical efficacy and 3-year survival and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years
* Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
* cT1-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
* American Society of Anesthesiology score (ASA) class I, II, or III
* Written informed consent

Exclusion Criteria:

* patients whose previous history of chronic shoulder pain
* Women during pregnancy or breast-feeding
* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* Enlarged or bulky regional lymph node envelop important vessels
* History of other malignant disease within past five years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* History of continuous systematic administration of corticosteroids within one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of predicted values
* Difficulty of understanding V A S(Visual Analogues Score).
Endometrial Thickness and Subendometrial Vascularity in Anovulatory Polycystic Ovarian Syndrome Patients Treated by Metformin

The participants will receive metformin 500mg 3times per day for 3months and one month is left for spontaneous pregnancy to occur or not (primary outcome ) and the investigators will check endometrial thickness and subendometerial vascularity as markers of endometrial receptivity before and after the treatment.


Eligibility Criteria:
Inclusion Criteria:

* PCO syndrome patients have the following criteria:

Age of the patient between 20 - 40 years old. All subjects are not on a specific diet nor a certain program of physical exercise Complaining of infertility either primary or secondary due to PCOS.

N.B: The diagnosis of PCO syndrome was made according to the Androgen Excess and Polycystic Ovarian Syndrome Society: the presence of the following criteria have been required for the diagnosis of PCO syndrome:

Hyperandrogenism: Hirsutism and/or Hyperandrogenaemia Ovarian Dysfunction : Oligo-Anovulation and /or Polycystic ovaries Exclusion of other Androgen Excess or related disorders as :( deficient nonclassic adrenal hyperplasia, androgen-secreting neoplasms, androgenic/anabolic drug use or abuse, Cushing's syndrome, the Hyperandrogenic-Insulin Resistance-Acanthosis Nigricans syndrome, thyroid dysfunction, and hyperprolactinemia).

Exclusion Criteria:

* Age below 20 or above 40. Women who intended to start a diet or a specific program of physical activity. Concurrent medical illness as cardiovascular, neoplastic and hepatic disorder. Pelvic pathology. Tubal, Uterine, Male factor of infertility. Endocrinological factors including: diabetes Mellitus,hypothyroidism, hyperprolactinaemia, Cushing's syndrome, and non- classical congenital adrenal hyperplasia.

Patients who are ovulatory during the ovarian cycle
A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation

The study is designed as a randomized, double-blind, parallel-group, multi centre study comparing perception and tolerability of investigational product and comparator. In the randomized part of the study the subjects will be given either LoFric Primo (POBE) or the comparator LoFric Primo (PVC) for use over 4 weeks. The hypothesis is that subject perception and satisfaction of POBE is equal to or better than for PVC.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Males and females aged 18 years and over
* Experienced users of LoFric Primo with a minimum of one month of use
* Practice CIC with LoFric Primo at least 3 times per day
* Adults able to read, write and understand information given to them regarding the study

Exclusion Criteria:

* Ongoing symptomatic UTI
* Suspicions of possible poor compliance with CIC during the study period
* Previous enrolment or randomisation of treatment in the present study
* Pregnancy
* Subjects not able to perform self-catheterisation
Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

The objective of this investigation is to asses with validated scales, the impact on the quality of life of men suffering of moderate to severe incontinence of the use of Conveen Optima urisheath in comparison with their usual absorbent protection.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18
* Out clinic patient
* Patient using absorbent protection for his urinary incontinence
* Moderate to severe urinary incontinence (1 hour pad test \> 10g)
* All kind of stable urinary incontinence
* Patient able to apply himself the device
* Patient able to understand the questions
* Patient having given his informed consent
* Patient whose overall treatment for his urinary incontinence is not modified during the study

Exclusion Criteria:

* Patient having a retracted penis
* Patient having skin problem on the penis
* Patient using urisheaths
* Bedridden patient
* Institutionalized patient
* Patient with indwelling catheter or under intermittent catheterisation
* Patient with fecal incontinence leading to the use of absorbent protection
* Patient suffering of urinary tract infection
Clinical Study of rATG Individualized Administration in Haploidentical Hematopoietic Stem Cell Transplantation

The purpose of this prospective, open-label, pairing design, single-center study is to evaluate the effect of individualized rATG dosing vs traditional weight-based rATG dosing regimen（10mg/kg）for patients with acute leukemia undergoing a myeloablative conditioning regimen and haploidentical hematopoietic stem cell transplantation (haplo-HSCT).

Allogeneic hematopoietic stem-cell transplantation (HSCT) is a potentially curative treatment option for acute leukemia. Haploidentical hematopoietic stem cell transplantation (haplo-HSCT) has become the main choice for acute leukemia in China. Major difficulties of the procedure include graft-versus-host disease (GVHD), graft failure, and relapse. As an important role of haplo-HSCT, Rabbit anti-thymocyte globulin (rATG), a polyclonal rabbit-derived antibody that depletes lymphocytes, including T cells, was introduced to prevent GVHD and transplant rejection.

The recommended dose of rATG in haplo-HSCT is 10 mg/kg. However, while the traditional weight-based rATG dosing regimen (10mg/kg) reduces the incidence of GVHD, it increases the risk of delayed immune reconstitution, viral reactivation, and relapse in patients. Our previous retrospective study showed that active ATG exposure (area under the curve, AUC)) post-transplantation is associated with immune reconstitution, GVHD, relapse, survival, and viral reactivation in HSCT of acute leukemia patients. Identifying the optimal dose of ATG to achieve the optimal exposure range of active ATG is a pressing clinical issue.

The pharmacokinetics of ATG varies significantly in both pediatric and adult populations, especially the active ATG levels, and clarifying the relationship between the pharmacokinetics of ATG and the prognosis of patient outcomes can help in precise treatment. By constructing a population pharmacokinetic model of ATG, we can provide an individualized optimal dose of ATG based on factors prior to transplantation. ATG individualized administration may improve the survival and quality of life of patients undergoing haplo-HSCT. A prospective pairing design trial is required to evaluate the effect of individualized rATG dosing vs traditional weight-based rATG dosing regimen (10mg/kg) for patients with acute leukemia undergoing haplo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

1. All patients were diagnosed with acute leukemia.
2. All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the myeloablative conditioning regimen.
3. All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.

Exclusion Criteria:

Patients with any conditions not suitable for the trial (investigators' decision).
Expiratory Flow Limitation and Postoperative Complications

Expiratory flow limitation (EFL) occurs when flow ceases to increase with increasing expiratory effort. In any circumstances EFL predisposes to pulmonary dynamic hyperinflation and its unfavorable effects such as increased elastic work of breathing, inspiratory muscles dysfunction, and progressive neuroventilatory dissociation, leading to reduced exercise tolerance, marked breathlessness during effort, and severe chronic dyspnea. Our hypothesis is that EFL should affect post operative outcomes like incidence of pulmonary complication and length of stay in hospital


Eligibility Criteria:
Inclusion Criteria:

* General anesthesia
* Duration of the surgery \>2 hours

Exclusion Criteria:

* \<18 years
* Consensus not given
Exercise Testing Protocols for Females and Males With CAD

The aim of this study is to determine if the test that allows males to achieve a higher VO2 (a measure of oxygen use during exercise) is different for females. The purpose of this study is to test 4 different exercise testing protocols to compare measured oxygen consumption in females and males with CAD (disease caused by the buildup of plaque in the artery walls which can lead to insufficient amounts of blood, nutrients and oxygen being supplied to the heart). The 4 exercise tests that will be completed on the treadmill are the modified Balke, modified Bruce, modified Naughton and University of Ottawa Heart Institute Slow Ramp protocols. Each test has a different stage duration (the amount of time that the test remains at a pre-determined speed and incline), and incremental increase in speed and incline.

The main purpose of this study is to compare VO2 peak (the maximal amount of oxygen utilized during the exercise test) of females and males with CAD in 4 different exercise protocols. For example, the investigators will find out:

1. which exercise protocol is more likely to achieve a higher peak V̇O2 in females and which protocol is more likely to achieve a higher peak V̇O2 in males,
2. if enjoyment affects the duration of the test, and
3. how different exercise test protocols will provide different results of maximal oxygen used by the participant's body during the exercise test.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older;
2. previous CAD diagnosis by a physician;
3. can perform a CPET until volitional exhaustion;
4. are able to self-ambulate on a treadmill;
5. are at least 8 weeks post cardiovascular event or procedure (i.e., percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)); and,
6. are able to provide written informed consent.

Exclusion Criteria:

1. cannot speak, read, write, or understand English or French;
2. currently not enrolled in a CR program;
3. have recently changed (or planning to change) PA levels within the previous 4 weeks (as this may impact the ability to compare outcomes between exercise testing protocols);
4. have heart failure with an ejection fraction \<45% (indication of possible cardiomyopathy);6
5. have an arrythmia (relative contraindication for exercise testing),6 peripheral artery disease, valvular disease, severe aortic stenosis, cardiomyopathy, SCAD and/or COPD (contraindications for maximal exercise testing);
6. has an ICD;
7. is pregnant (sustained vigorous exercise in pregnant women may induce fetal bradycardia)
8. is unable to complete submaximal exercise testing (i.e., treadmill, due to musculoskeletal limitations).
Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering.

Shivering is very common after spinal anaesthesia. Many studies have investigated the role of adding adjuvants to the local anaesthetics to decrease the incidence of post-spinal shivering. Non of the studies n the literature review have investigated the role of different dose of local anaesthetic alone in reducing the incidence of post-spinal shivering. In the present study the investigators aimed to compare the effect of different local anaesthetic dose in reducing post-spinal shivering.

After approval of the ethics committee, department of anaesthesia, Menoufia University and written informed consent, a hundred full-term pregnant ladies undergoing elective cesarean section were enrolled in this study.

The pregnant ladies were randomly assigned using a computerised software to one of two groups, low dose bupivacaine (LB) and high dose bupivacaine (HB), 50 patients each according to bupivacaine dose. Group LB received low dose bupivacaine (8 mg hyperbaric bupivacaine) Group HB received high dose bupivacaine (10 mg hyperbaric bupivacaine).

Vital signs including heart rate and mean arterial blood pressure intra-operatively until the end of surgery.

The severity of shivering was the primary endpoint. Shivering was graded using a scale: 0, no shivering; 1, piloerection but no visible muscle activity; 2, muscular activity in one group of muscle; 3, muscular activity in more than one muscle group but not generalized movement; and 4, shivering involving the movement of the whole body. Shivering score was recorded for the whole study period.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 22 and 35 year old, and American Society of Anesthetists (ASA) I or II were included in the study and consented to have spinal anaesthesia for their section.

Exclusion Criteria:

* Patients who had contraindication to spinal anesthesia, high-risk pregnancy, history of seizures, mental illness, acute fetal distress, and patients refused spinal anesthesia were excluded from the study.
Fetal, Obstetrics and Reproduction Genomics

The purpose of this study is to determine the impact of a clinical screening strategy and genomic analysis of the factors involved in Placental Dysfunction (Preeclampsia and IUGR) in women of advanced maternal age undergoing assisted reproduction techniques (ART), specifically, in vitro fertilization (IVF) and oocyte donation.

Given society's shift towards later childbearing, partly related to increased career development, women are increasingly delaying childbearing and, as a result, face declining biological fertility and increased maternal morbidity and adverse perinatal pregnancy outcomes, as well as increased use of ART. Preeclampsia (PE) complicates 2% of pregnancies and is a leading cause of severe maternal and perinatal complications. There is no curative treatment, and the only recognized beneficial primary prevention is low-dose aspirin. Finding an effective method of predicting and preventing placental dysfunction (PD) in women of advanced maternal age undergoing ART remains a challenge.

The investigators believe that maternal and perinatal complications in this group of pregnant women could be detected preclinically and allow early preventive actions.

On the other hand, establishing a differentiated genomic pattern in this group of patients would allow preventive actions both pregestational and during gestation. Furthermore, FORgenomics can be used to externally validate a prediction model for the development of PE and IUGR in pregnancy after IVF/ovodon. Our results could be applicable in most healthcare settings and have important implications for maternal-fetal health.

The justification and hypothesis of this proposal is: (1) maternal and perinatal complications in this group of pregnant women could be detected preclinically and allow preventive actions by systematic screening based on Doppler ultrasound of uterine arteries and anti-angiogenic factors (sFlt-1/PlGF ratio) at 13, 16, 20 and 26 weeks to identify pregnant women at high risk for developing PE; (2) morphological ultrasound at 13, 16 and 20 weeks would help to establish a standardized procedure for early detection of congenital anomalies and (3) establishing a differentiated genomic pattern in this group of patients would allow preventive actions both pregestational and during gestation.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Age ≥40 years
* Signed informed consent
* Gestation obtained by IVF or ovodonation

Exclusion Criteria:

* Non-ongoing pregnancy
* Gestation obtained by artificial insemination
* Naturally obtained gestation, without ART
* Multiple pregnancy
* Pregnancies complicated by major fetal abnormality identified at the first-trimester ultrasound
* Age \<18 years
* Poor understanding of the Spanish or English languages
* Refusal in informed consent to participate in the study
* Participation in another intervention study that could modify follow-up