cyrilzakka/clinical-trials huggingface dataset:
Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy for the treatment of localized Chinese hepatocellular carcinoma

The purpose of this study is to determine the maximal tolerated dose (MTD) of carbon ion radiotherapy (CIRT) in the treatment of localized Chinese hepatocellular carcinoma with respective to toxicity and tumor control. Participants will be treated with CIRT with escalating dose regimens based on the tumor location to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 3 months after the completion of CIRT. Primary endpoint is toxicity, second endpoint is progression-free survival, overall survival and tumor response.

Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed hepatocellular carcinoma (HCC) or clinical diagnosis of HCC according to American association for the study of liver diseases （AASLD）-guidelines or clinical diagnosis criteria based on Alpha Fetoprotein （AFP), and radiological images proposed by Liver Cancer Society, Chinese Anti-Cancer Association;
2. no clinically distant metastasis;
3. Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 12 cm;
4. age ≥ 18 and \<80 years of age;
5. Karnofsky Performance Score ≥ 70;
6. No previous invasive cancer (within 5 years before the HCC diagnosis)except for skin non-melanoma cancer or non muscle invasive bladder cancer; Ability to understand character and individual consequences of the clinical trial;
7. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;

Exclusion Criteria:

1. Distant metastasis (M1);
2. maximal tumor size is more than 12 cm;
3. tumor invading adjacent gastrointestine (T4);
4. Child push score B or C;
5. Previous hepatic radiotherapy;
6. Severe systemic disorders;
7. Previous malignancy (within 5 years) except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer;
8. Non conformity of the radiotherapy dose distribution when compared to the dose constraints;
9. Psychiatric disorders or any other condition that can make unreliable the informed consent;
Modulating the GIP System in Patients With Acromegaly Due to a Pituitary Tumor

Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma

Aim: To determine the importance of the GIP system in patients with acromegaly who has paradoxical growth hormone secretion during an oral glucose tolerance test (OGTT) using a GIP antagonist (GIP-A).

Thirty participants (age 18-75 years) with normal kidney and liver parameters and hemoglobin levels will be included in a placebo-controlled cross-over study. The study consists of two study days with concomitant infusions of A) GIP-A or B) saline (placebo).

A paradoxical growth hormone secretion to an OGTT is here defined as an increase in plasma growth hormone levels of ≥30% from baseline based on a mean value of the definitions in the literature.

Regazzo et al. (2017) European Journal of Endocrinology 176, 543-553 Mukai et al. (2018) The Journal of Clinical Endocrinology and Metabolism 104(5), 1637-1644 Hage et al. (2019) The Journal of Clinical Endocrinology and Metabolism 104(5), 1777-1787 Scaroni et al. (2019) J Clin Endocrinol Metab 104(3), 856-862

Eligibility Criteria:
Inclusion Criteria:

* Patients under clinical investigation of acromegaly disease with normal kidney function, liver function and hemoglobin levels.

Exclusion Criteria:

* Medication for acromegaly, adenectomy, liver disease, uncontrolled anemia, severe heart disease, uncontrolled high blood pressure (\>170/100 mmHg), current pregnancy
A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma

The study will examine the safety profile of SGN-CD19B administered as a single agent. The main purpose of the study is to estimate the highest dose that does not cause unacceptable side effects of SGN-CD19B in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) subtypes of diffuse large B-cell lymphoma (DLBCL) and Grade 3 follicular lymphoma (FL3). Additionally, the pharmacokinetic profile and antitumor activity of SGN-CD19B will be assessed.

SGN-CD19B will be given to patients at increasing doses every 28 days (or on an alternative dosing schedule of every 42 days).

Individual expansion cohorts of up to approximately 20 patients will be opened at dose levels selected by the Safety Monitoring Committee based on the aggregate known safety and activity data to further define the safety and antitumor activity in refractory and relapsed disease subgroups.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies
* Measurable disease
* Eastern Cooperative Oncology Group status of 0 or 1
* Adequate baseline renal and hepatic function

Exclusion Criteria:

* Prior treatment with CD19 directed agents unless CD19 expression is confirmed after completion of CD19-directed treatment
* Known HIV, active hepatitis B or active hepatitis C infection
* Prior allogeneic stem cell transplant
* Inadequate lung function
* Anticancer treatment within 4 weeks of study drug or 2 weeks if patient experienced disease progression on prior treatment
A Multicenter Phenotype-Genotype Analysis of DM1 Patients in China

Myotonic dystrophy 1 (DM1) is an autosomal, dominantly inherited neuromuscular disorder characterized by skeletal muscle weakness, myotonia, cardiac conduction abnormalities, cataracts, and other abnormalities. This disease results from an expansion of a cytosine-thymine-guanine (CTG) trinucleotide repeat in the 3'-untranslated region of the dystrophia myotonica protein kinase (DMPK) gene on chromosome 19. Currently, there is limited phenotype and genotype data available for DM1 patients with Chinese Han ethnicity. Therefore, this study aims to fill this gap and provide complementary data.

This is a multicenter-based, prospective, observational study that primarily focuses on the diagnosis and progression of DM1 patients in China. The investigators collect patient data, including basic information, strength evaluations, genetic data, electromyography results, cognitive performance, and MRIs.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80 years
* With enough cognitivie ability to understand the content and sign the informed consent form
* With CTG repeats \>50 in DMPK gene, revealed by PCR test

Exclusion Criteria:

* Patients with severe mental illness, or severe anxiety and depression
* With comorbidities such as traumatic brain injury and cranial tumors
* A history of alcoholism, psychotropic substance abuse, etc.
* Patients with severe medical conditions and unstable vital signs that cannot tolerate the tests.
* Female in pregnancy
Ultrasonography and Health Education Can Reduce the Unnecessary Caesarean Section in Bangladesh

A caesarean section (C/S) is a surgical procedure performed to prevent difficulties during childbirth. World Health Organization considered the standard rate for the C/S would be between 10% and 15%. However, since 2000 the rate of C/S was increasing globally, and it became about twofold from 12.1% to 21.1% in 2015.

In Bangladesh, C/S continued to increase from 8% (2007) to 33% (2017). Medically unnecessary C/S was estimated about 77% of all C/S in 2018, and it was increased from 66% since 2016. In Bangladesh, unnecessary C/S observed 9.0% and 3.2% C/S done due to avoid labour pain and 5.8% for the convenience of the mother. The economic burden of each C/S is average USD 612 and unfortunately, each patient spends this amount of money from out of pocket. Aim of this study is to do ultrasonography and health education can reduce unnecessary caesarean section among pregnant women compared to control group in a resource poor setting.

Investigators will conduct this randomized controlled trial (RCT) at Dhaka and Sir Salimullah Medical College \& Hospital, and two rural Upazila Health Complexes (Savar Upazila Health Complex and Munshigonj General Hospital). Investigators will randomly select one urban hospital from two urban hospitals and one rural hospital from two rural hospitals for the intervention. The other one urban and one rural hospital will be assigned as control hospitals. One research staff, who will not involve any of the research activity of this trial, will do this randomization. Pregnant mothers will be identified and recruited during their routine antenatal visits. Pregnant mothers receive 2 USG during their routine ANC visits at 1st visit of 8-12 weeks and 4th visit of 36-38 weeks. In the intervention centres, Investigators will perform additional 4 ANC visits at 20, 30, 36 and 40 weeks (total 8 visits) and USG additional 2 times during the 2nd visit of 24-26 weeks and 5th visit of 34 weeks (2 routine USG + 2 USG in 3rd and 5th ANC visits and even more USG if needed + Health education; pictorial flip chart showing danger sign during pregnancy and potential risks for unnecessary caesarean delivery to increase awareness for safe delivery) for all the enrolled pregnant mothers. In the control centres, Investigators will collect information from the pregnant mothers.

Investigators are expecting the pregnant women who will receive antenatal care with ultrasonography and health education will have reduced number of unnecessary C/S compared to control group who will not receive those.


Eligibility Criteria:
Inclusion Criteria:

1. All the pregnant mothers irrespective of age who will be attending the designated hospitals/health complex.
2. We will include all pregnant mothers who will have/have not complication to see the delivery outcome with indication of normal delivery and CS.
3. Willing to participate in the study.

Exclusion Criteria:

1. Not willing to participate.
2. Early Pregnancy with indication for C/S (co-morbidities, H/O previous C/S etc.)
Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration

A study is conducted to determine the effectiveness of prism spectacles in improving visual acuity with age related macular degeneration patients and to assess the improvement in quality of life in patients by using prism spectacles.

A random sampling technique will be used to allocate patient in interventional and non-interventional group. The diagnosed patients of age-related macular degeneration are assessed for prism spectacles for near vision and prism glasses will be dispensed to the patients. Each subject will be interviewed to fill the Proforma after taking the informed consent. The results of this study will show the effectiveness of prism glasses in patients with age related macular degeneration in their daily routine near work as compared to conventional glasses.

Eligibility Criteria:
Inclusion Criteria:

* Patients having age \>50 years with age related macular degeneration.
* Patients of both genders (male and female).
* Participants who will be willing to give informed consent for participation in the study.

Exclusion Criteria:

* Presence of all ocular disease and systemic ocular pathologies able to impair visual function.
* Presence of disorders causing choroidal neovascularization other than age related macular degeneration.
* Patients with mental illness, dementia, and severe physical limitations
HDAC Activity in Peripheral Skeletal Muscle in COPD

We wish to study the effect of Chronic Obstructive Pulmonary Disease on the activity of the nuclear transcription pathway in peripheral skeletal muscle to determine whether altered activity of this pathway may be responsible for the muscle dysfunction observed in these patients.

Peripheral muscle dysfunction is well recognised in COPD. We wish to study patients who we have found to have weak quadriceps muscles and study the molecular mechanisms underlying this problem. Patients will be well characterised with regard to their physiologic parameters and quadriceps muscle biopsies will be taken. These biopsy samples will be analysed with respect to NFkappaB activity and HDAC activity by nuclear extraction and for muscle inflammatory cytokines. We know that in the lung tissue of COPD patients there is evidence of a reduction in HDAC activity which might be responsible for the higher levels of pronflammatory cytokines in the lung. We will also study a healthy control group and a small selection of patients who are in respiratory failure due to idiopathic scoliosis in the same way.

Eligibility Criteria:
Inclusion Criteria:

COPD

-

Exclusion Criteria:

Aspirin therapy Bleeding diasthesis Neuromuscular disease
Group B Streptococcus Colonization in Mother-newborn Dyads and Association With Serotype-specific Capsular Antibodies in Karachi, Pakistan.

Group B Streptococcus (GBS) of which there are 10 serotypes of varying invasive potential is a major cause of invasive bacterial disease in neonates and young infants. Approximately two-thirds of invasive GBS disease occurs during the first three days of life of which 75%-90% occur within 24 hours of birth in the absence of clinical interventions such as intrapartum antibiotic prophylaxis (IAP). Invasive GBS disease during the first week (Early onset disease, EOD) of life results from vertical acquisition of GBS in utero by the foetus or during labour from recto-vaginally colonized women. The incidence of EOD in full-term new-borns has declined by approximately 90% in countries where there is routine screening of pregnant women for GBS recto-vaginal colonization at 35-37 weeks of gestational age and where IAP is provided 4 hours prior to delivery to colonized women. The strategy for routine screening for GBS colonization coupled with IAP, however, is not logistically feasible in most resource-constrained countries including Pakistan and has also been shown to be not cost-effective including in some high-income countries. The current CDC recommendation for the isolation of GBS from vaginal and rectal or recto-vaginal swabs is by initial growth in a selective broth medium with antibiotics, followed by subculture on blood agar or selective media.

This study aims to address the knowledge gaps to better inform the epidemiology of GBS in a low income setting and address some of the critical limitations of current data from low-middle income countries. Women who had normal vaginal delivery at term (\>37 weeks of gestation age) will be enrolled in this study. Recto-vaginal swabs from the mothers will be collected for GBS.

All samples will be collected by trained midwives/physician before delivery. All newborns born to these mothers will be followed at 28th day after birth to assess their health status with emphasis on possible invasive disease episodes.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women age 13-49 years age.
* Pregnant women ≥37 weeks' gestation.
* Delivering by normal vaginal delivery.
* Are able to provide informed consent.

Exclusion Criteria:

1. Unwilling to consent to be on the study
2. Women who had taken any antibiotic treatment in previous two weeks 3 .Women who have blood transfusion in 30 days before delivery.
Effect of RO On GB During TKR Severe Varus Deformity

Effect Of Reduction Osteotomy On Gap Balancing During Total Knee Replacement For Severe Varus Deformity

Severe varus deformity with a tibio femoral angle of 15° or more as measured on full-length weight-bearing radiographs necessitates extensive release of the medial structures to gain neutral limb alignment during total knee arthroplasty (TKA). progressive releases of the medial structures are performed until medial and lateral envelopes are equally balanced. This technique, however, faces a risk of over-release and subsequent instability, ultimately resulting in the use of a thicker polyethylene insert or even a constrained-type prosthesis. Reduction osteotomy is known as a soft tissue-sparing technique for soft tissue balancing, and it is capable of reducing the amount of release required to balance the knee and of preventing over release of medial structures. Dixon et al . and Mullaji et al . proposed the effectiveness of down-sizing the tibial component in the case of knees with severe varus deformity Aim of the work: Assess the effect of reduction osteotomy on gab balancing during total knee arthroplasty for severe varus deformity -What is the amount of deformity correction achieved with reduction osteotomy during TKA in varus knees? - What is the correlation of amount of deformity correction achieved to the amount of bone osteotomized and the degree of varus deformity?

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe varus deformity more than 15 degrees (long film-mechanical axis)
* Patients with bone defect of medial tibial condyle

Exclusion Criteria:

* Patients with extra-articular deformity
* Patients with valgus deformity
Functional Outcomes of an Accelerated Rehabilitation Protocol for ACL Reconstruction in Amateur Athletes

The main goal of a rehabilitation program after an ACL reconstruction is to regain mobility and muscle function and ultimately to return to sports participation. Purpose of the study: to investigate the effect of the accelerated rehabilitation program on knee pain, and function in patients post ACLR surgery. Fifty adult amateur males athletes who underwent ACLR surgery participated in this study, their age ranged from 18 to 35years.They were randomly assigned into two equal groups. Group (A) received accelerated rehabilitation protocol and group (B) received conventional physical therapy program. Treatment sessions were conducted 5 times per week for 22 weeks for both groups. All patients assessed pre and post treatment for pain intensity using visual analogue scale (VAS), and knee function using knee injury and osteoarthritis outcome score (KOOS), knee effusion, and LSI of Hop test.


Eligibility Criteria:
Inclusion Criteria:

* Patients were participated in this study if they fulfilled the following criteria:

  * Underwent pre-operative rehabilitation program with minimal knee effusion and full extension, good patellofemoral mobility, and the patient can actively control the quadriceps.
  * Have an ACLR with an autolongous hamstring (HT) graft.
  * Age range from 18-40 years old.
  * Football players or who perform physically demanding work.
  * Have no other ligamentous injury.
  * Have nomeniscectomy previous to or simultaneouswith ACLR.
  * Have no cartilage damage.

Exclusion Criteria:

* • Patients younger than 18 or older than 35 years old

  * Have ACLR with any graft other than hamstring (HT) graft
  * Have ACL revision surgery
  * Have other ligamentous injury
  * Have a meniscectomy previous to or simultaneous with ACLR.
  * Had meniscal repair simultaneously with ACLR
  * Have cartilage damage.
Dexmedetomidine in Pediatric Cardiac Surgery

Dexmedetomidine is a selective α-2 receptor agonist with a sedative and cardiopulmonary profile that makes it an attractive anesthetic for pediatric patients with congenital heart disease (CHD). The aim of this study was to investigate the renal protective effect of dexmedetomidine in the perioperative setting in children with heart disease.

Total 144 pediatric patients allocated dexmedetomidine (DEX) and did not receive the drug (NoDEX) group.

The primary objective of this study was to assess the relationship between the use of intraoperative dexmedetomidine and the incidence of acute kidney injury in pediatric patients undergoing cardiopulmonary bypass. The secondary objective was to determine whether there was an association between dexmedetomidine use and duration of mechanical ventilation or cardiovascular ICU stay.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing congenital cardiac surgery

Exclusion Criteria:

* history of allergy or anaphylaxis to study drug
* preexisting renal dysfunction (preoperative creatinine \>1.5mg/dl)
* diabetes
* liver profile abnormality
The Effect of Mask Design on Transcutaneous Carbon Dioxide in Healthy Volunteers: A Pilot Clinical Investigation

The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts transcutaneous CO2 in healthy volunteers on NIV therapy. The main questions it aims to answer are:

* To assess if mask design impacts transcutaneous CO2 in healthy volunteers.
* To assess if mask design impacts tidal volume or respiratory rate in healthy volunteers.

Participants will attend three study visits:

* Visit 1. Participants will be fitted to use non-invasive ventilation briefly to acclimatize them to using the therapy.
* Visit 2. Participants will receive NIV with one of two masks. They will be asked to breathe through their mouth or through their nose, with a break from NIV in between the two sessions of NIV.
* Visit 3. Participants will receive NIV with the other mask, repeating Visit 2.

The study compares breathing with two different NIV masks, the interventional mask and the conventional NIV mask. Participants will be monitored by transcutaneous carbon dioxide, electrical impedance tomography (EIT) and heart rate, oxygen and respiratory rate monitors.

Participants will attend three study visits:

* Visit 1. Participants will be fitted to use NIV briefly to acclimatize them to using the therapy and ensure the two study masks fit. Participants that fit the masks and tolerate NIV well will be invited to attend two further visits.
* Visit 2. Participants will be randomized as to which order they receive the masks and which order they conduct mouth breathing and nose breathing. Baseline readings of normal unsupported breathing will be taken prior to going on NIV. Participants will the receive NIV with one of two masks for ten minutes, and will be instructed to either breathe with their mouth open or their mouth closed. There will then be a break from NIV of at least ten minutes until baseline values of respiratory parameters have returned. Then there will be a second ten minute period of NIV when the participant will be instructed to breathe through the other way - mouth-closed or mouth-open. One NIV therapy has been removed the participant will remain attached to the study monitoring equipment until respiratory parameters have returned to normal.
* Visit 3 is a repeat of Visit 2 with the other study mask. The study is then complete.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over
* Able to give informed consent

Exclusion Criteria:

* Unable to tolerate non-invasive ventilation (NIV)
* Unable to adequately fit an NIV mask
* Claustrophobia while using NIV
* Reported pregnancy
* Symptoms of cold or flu (included COVID-19) in previous twenty four hours
* Pneumothorax or history of previous pneumothorax