cyrilzakka/clinical-trials huggingface dataset:
High-resolution CE-MRA of Children's Hip Joint

The goal of this observational study is to learn about the feasibility of enhanced three-dimensional water-selective cartilage (3D-WATSc) sequence in displaying the vessels of children's hip by magnetic resonance. The main questions it aims to answer are:

* Could the images of enhanced 3D-WATSc sequence show the healthy side hip joint vessels in children?
* Could the images of enhanced 3D-WATSc sequence show the vascular disease of the suffering side hip joint in children?

Participants with unilateral hip disease will undergo the magnetic resonance examination including enhanced 3D-WATSc sequence. The pelvic plain film and magnetic resonance images will be collected and analysed.

Researchers will compare the images of of the normal side with the images of the abnormal side to see if the enhanced 3D-WATSc sequence images could show the vascular disease of the suffering side hip joint in children?


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months-14 years who are diagnosed as hip disease after screening by pediatric orthopedic surgeon in Children's Hospital of Chongqing Medical University during the study period. The hip disease contain developmental dysplasia of the hip, Perthes disease, infection of the hip, inflammation of the hip, fracture of the hip, and Meyer's dysplasia.

Exclusion Criteria:

* patients with bilateral hip joint disease; patients with claustrophobia;Patients with metal implants (such as pacemaker implantation)
Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer

Dostarlimab belongs to a class of drugs called PD-1 inhibitors that use your own immune system to treat cancer (immunotherapy). It is designed to stop cancer from growing by helping your immune system recognize and fight the cancer. This investigational medicinal product (IMP) has been approved by the Belgian authorities, but not for the treatment of colon cancer.

It is known that a small number of patients with pMMR/MSS colon cancer may have significant response to medication of this type (immunotherapy) depending on each person's biology.

Trial intervention for all patients will be neo-adjuvant dostarlimab 500 mg IV, given alone by intravenous infusion. Two administrations of dostarlimab are foreseen, at three weeks interval, before surgery for your colon cancer. It has not yet been proven that this treatment can cure, improve or stabilise your disease or condition.

The study aims to investigate specific molecular changes in tumour and blood after dostarlimab monotherapy administered and before surgery which could be associated with improved response to conventional treatment in some patients. If you decide to participate, as the duration of treatment with dostarlimab is 6 weeks, surgery may be slightly delayed compared to patients that are not treated with dostarlimab and go directly for surgery. It remains uncertain if this is beneficial in your personal situation but some patients might experience significant response. The risks have been carefully assessed and the potential benefits for some patients are considered important and justify undertaking the treatment.

Subsequent therapy after surgery remains at the discretion of the treating physician.

The duration of a patient on trial will last up to 4 months from the first dose of dostarlimab and afterwards 2 years of follow up is applicable.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age and capable of giving informed consent
* primary adenocarcinoma colon cancer than can be removed surgically, staged cT3-4, cN0-2, cM0 or stage III
* tumour expresses an MMR proficient/microsatellite stable called MSS
* tissue samples from tumour and colon mucosa available for molecular analyses
* capable of receiving immunotherapy
* adequate general health status and organ function (blood tests)

Exclusion Criteria:

* no prior cancer treatment
* not pregnant and using effective contraception if applicable
A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome

A study to examine the safety (and potential efficacy) of the adult stem cell investigational product, MultiStem, in adults who have Acute Respiratory Distress Syndrome (ARDS). The primary hypothesis is that MultiStem will be safe in ARDS patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe ARDS, as defined by the Berlin definition, requiring an endotracheal or tracheal tube
* Able to receive investigational medicinal product within 96 hours of meeting the last of the ARDS diagnosis criterion

Exclusion Criteria:

* Concurrent illness that shortens life expectancy to less than 6 months
* Other serious medical or psychiatric illness
Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC)

Stereotactic Radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC).

A Danish phase II study.

Combination chemotherapy (e.g. FOLFIRINOX (5-fluorouracil, irinotecan, oxaliplatin), Gem-Abraxane, Gem-Cap, Gem-S1) is standard of care in patients with LAPC but more and more scientific studies point to the fact that patients without sign of progressive disease (PD) will benefit from additional radiotherapy and especially SBRT.

The sample size is based on Simon's two stages mini-max design. This design ensures early study termination if there is insufficient effect.

A resection rate less than 10% after SBRT is not clinically acceptable. Assuming a significance level at 0.1 (α = 0.1) and a power at 90% (β = 0.10) it can be calculated, that 16 patients should be included in the first part of the study. The enrolment will continue until 16 patients have completed SBRT and have been re-evaluated for resection by CT scan (and endoscopic ultrasonography + laparoscopic ultrasound, if available). If 1 or less out of the first 16 consecutive patients are being resected the investigators will reject our hypotheses and close the study after the first stage of accrual. If 2 or more patients are resected, an additional 9 patients will be accrued in the second stage. If at least 4 out of 25 patients are resected, a true resection rate of 30% cannot be excluded, and the investigators will conclude that the treatment is effective enough to continue with future studies.

To ensure 25 evaluable patients the investigators will include a total of 30 patients.

Eligibility Criteria:
Inclusion Criteria:

* LAPC (Karolinska Type B, C or D1)
* Cytologically or histologically verified adenocarcinoma/carcinoma
* Prior combination chemotherapy for 2-6 months (unless contraindicated) and no sign of progressive disease
* The patient is medically operable (i.e. no co-morbidity which can preclude anaesthesia or surgery)
* World Health Organization performance status 0-1
* Age ≥ 18 years
* Adequate hepatic function: bilirubin \<3.0 x Upper Normal Limit, International Normalized Ratio \<1.6, Activated Partial Thromboplastin Time \< 1,5 x Upper Normal Limit. Patients with obstruction of bile duct or gut must be drained before start of therapy
* Oral and written informed consent must be obtained prior to registration with planned date of first treatment within 14 days from registration.

Exclusion Criteria:

* M1 disease
* Prior radiotherapy to abdominal cavity
* Pregnancy or breast-feeding. Fertile patients must use adequate contraceptives
* Severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months)
Trima Accel® System Post Count Algorithm Study

The purpose of this study is to optimize collected platelet yields in single and double platelet collections, while maintaining donor postplatelet count of \>100,000/µL.

This is a prospective, open-label, non-randomized study to evaluate Trima Accel System modified postcount algorithm software.

Platelets will be collected according to the Trima Accel System Operator's Manual. Collection procedures will include those in which:

1. a single platelet product is collected
2. a double platelet product is collected, with or without other components.

Study participation will be up to 8 days. The apheresis procedure can last from 25 to 150 minutes, dependent upon the product(s) to be collected, machine configuration, donor parameters, the quality of the vascular access, and the tolerance of the donor to the citrate anticoagulant.

Donors will have one apheresis procedure and follow-up with any serious adverse events for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Meets Blood Center criteria for blood donation and is scheduled for an apheresis procedure that includes a single or double platelet product. These criteria are based on FDA Regulations and American Association of Blood Banks (AABB) Guidelines.
* Appears to have adequate venous access to obtain a postprocedure platelet count.
* Has given written informed consent.

Exclusion Criteria:

* Has undergone a splenectomy.
Activation Programme's Impact on Seniors' Emotionality and Loneliness

The goal of this pilot study is to verify the short-term effectiveness of the Activation-Socialisation Intervention Programme (A-S IP) on the psychosocial survival of older adults in a specific care facility. The main questions it aims to answer are:

* Does the A-S IP reduce the rate of negative emotional states in older adults?
* Does the A-S IP increase the rate of positive emotional states in older adults?
* Does the A-S IP reduce feelings of loneliness in older adults? Researchers will compare the experimental group (older adults participating in the A-S IP) to a control group (older adults not participating in the intervention) to assess the impact on emotional states and loneliness.

Participants will:

* Participate in 40 activities based on three domains (Laughter Therapy, Reminiscence Therapy, and Cognitive and Social Skills Stimulation)
* Engage in group activities for four weeks, with daily sessions scheduled in the morning and afternoon
* Provide feedback on their experiences through surveys and questionnaires to assess their emotional states and satisfaction with the intervention

The study will also explore whether the intervention contributes to the well-being of older adults, as measured by changes in their emotional states and feelings of loneliness.

The study was registered retrospectively due to limited awareness of the registration requirement for behavioral interventions at the time of study initiation (in 2021). Initially, the research was designed as an exploratory study on a smaller scale, and the registration of a formal trial was not considered necessary.

As an early-career researcher and doctoral student, I was not initially aware of the necessity of registering behavioral intervention studies. However, as the study progressed and its significance became evident, I came to understand the importance of this process. Once I became aware of the registration requirements, I took the necessary steps to complete it accordingly.

Despite the late registration, the study was conducted according to a pre-specified protocol, with all methodological and ethical standards strictly adhered to (approved, for example, by the Ethics Committee of UMB). The hypotheses, study design, and analysis plan were defined prior to data collection, ensuring the integrity and transparency of the research.

Eligibility Criteria:
Inclusion Criteria:

* long-term residence in the facility,
* age over 62,
* willingness to participate,
* ability to participate (no severe cognitive or physical impairments)

Exclusion Criteria:

* significant physical problems,
* significant mental health problems,
* unwillingness to participate
Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 Months of Age

Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 months of age


Eligibility Criteria:
Inclusion Criteria:

* Healthy children of 11 to 15 weeks of age

Exclusion Criteria:

* Children who previously received any kind of Meningococcal C vaccine, DTaP-IPV-HBV-Hib vaccine or a Hepatitis B vaccine at birth
* Children who have a previous ascertained or suspected disease caused by N. meningitidis, Corynebacterium diphtheriae, Clostridium tetani, poliovirus, Hepatitis B or H. influenzae type b, culture proven Bordetella pertussis, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping
* Children who have had household contact with and/or intimate exposure to an individual with culture proven N. meningitidis serogroup C or Bordetella pertussis, within the previous 60 days
L-citrulline and Metformin in Duchenne's Muscular Dystrophy

The purpose of the study is to show that the intake of L-citrulline and metformin improves muscle function and delay of progression in patients with Duchenne's muscular dystrophy.

This is a single center, randomized, double-blind, placebo controlled study. The study medication consists of L-citrulline and metformin, respectively placebo given orally; 2.5 g L-citrulline or placebo will be given 3 times daily, metformin containing 250 mg or placebo will be administered 3 times daily. The duration of the study is 26 weeks and comprehends one screening and three study visits.

Amendment 1: Amended eligibility criteria

Eligibility Criteria:
Inclusion Criteria:

* Molecular diagnosis of DMD
* Patients 6.5 - 10 years of age at time of screening
* Ambulant
* Ability to walk 150 m in the 6 min walking distance (6MWT)
* D1 subdomain of the MFM scale \>40%
* stable treatment with steroids for \>6 months or steroid naïve patients

Exclusion Criteria:

* Previous (3 months or less) or concomitant participation in another therapeutic trial
* Use of L-citrulline, L-arginine or metformin within the last 3 months
* Known individual hypersensitivity to L-citrulline or metformin
* known or suspected malignancy
* Other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of investigator
* start of cortisone treatment or change in dosage \<6 months prior to screening
Exercise, Prediabetes and Diabetes After Renal Transplantation.

This study is designed to evaluate the feasibility of exercise to reverse prediabetes after transplantation to prevent Posttransplantation Diabetes Mellitus (PTDM).

The hypothesis of the study is that exercise will promote the reversibility to normal glucose metabolism in patients with prediabetes and eventually reduce the incidence of PTDM in renal transplant. The main objective of the study is to induce the reversibility of prediabetes by means of exercise. Additionally, the secondary objectives are: (a) to evaluate the compliance of exercise (b) improvements in metabolic risk factors profile: obesity, triglycerides, blood pressure and HDL cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old.
* Renal transplantation: beyond 6-12 months after transplantation with stable renal function
* IFG: 100-125 mg/dl and IGT 140-199 mg/dl.
* Ability or capacity to perform exercise.

Exclusion Criteria:

* Clinical conditions that preclude the treatment with exercise i.e. clinical instability: active infection, cancer, acute cardiovascular disease, advanced renal disease, pulmonar hypertension, chronic obstructive pulmonary disease, severe reumatological disorders, arthrosis, arthritis limb amputation, etc.
* Inability to understand the protocol.
* Severe psychological disease.
* PTDM.
* Diabetes before transplantation.
Use of Desferal for Prevention of ARDS in Hospitalised Cases Documented With Covid 19 Infection

To evaluate the efficacy of using Desferal injections for prevention of ARDS in moderate cases with fever , chest tightness and relevant chest images

COVID-19 is a condition caused by a coronavirus (called SARS-CoV-2) that was first identified in late 2019. In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. Recent theory showed that the severe respiratory manifestations could be due to iron toxicity which cause intense inflammation in the alveoli and hence the ground glass appearance that was seen in ragdiology imaging

Objective :

To evaluate the efficacy of using Desferal injections for prevention of ARDS in moderate cases with fever , chest tightness and relevant chest images

Randomisation:

Participants are randomly allocated to either standard care or standard care plus Desferal injection. Randomization will be done through computer generated list by principal investigator. Allocation will be determined by block randomisation, stratified by hospital. This will be carried out by an independent statistician, prior to the trial commencement, using Stata (StataCorp, College Station, TX, USA) to generate the allocation sequence. Allocations will be concealed within sequentially numbered, sealed opaque envelopes, prepared by two research assistants who are independent of the trial Blinding This study will be single blind. Doctors will not be blinded to intervention allocation due to lack of feasibility

Sample size:

Two hundred participants randomized into two groups each 100 individuals. The trial will begin as a 1:1 randomised trial Intervention Model Parallel assignment Desferal group An initial dose of 1000 mg should be administered at a rate NOT TO EXCEED 15 mg/kg/hr. This may be followed by 500 mg over 4 hours for two doses. Depending upon the clinical response, subsequent doses of 500 mg may be administered over 4-12 hours. The total amount administered should not exceed 6000 mg in 24 hours

Placebo group Will receive glucose 5% over 4 hrs infusion

Standard care :- including clexan 40, antibiotics, corticosteroids ( as anti-inflammatory agent) and hydroxychloroquine

Eligibility Criteria:
Inclusion Criteria:

* Patients positive for Covid 19 admitted to hospital with chest tightness

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Known severe hepatic impairment
* Known severe renal impairment
* Known porphyrias
* Diabetes mellitus
* Known G6PD deficiency
* Known myasthenia gravis
* Known severe psoriasis
* Known severe neurological disorders (especially those with a history of epilepsy - may lower seizure threshold)
Pain Function and QOL Undergoing Whole-Body Vibration and Exercise in End-Stage Knee Osteoarthritis

Knee osteoarthritis (KOA) is a chronic progressive disease that imparts substantial socioeconomic burden to society and healthcare systems. The prevalence of KOA has dramatically risen in recent decades due to consistent increases in life expectancy, and demand for joint replacement continues to rise. Total knee replacement is indicated for end-stage KOA, as it is very effective in terms of pain relief, improvement of function, and quality of life. However, the investigators will be facing an unsustainable joint replacement burden, with significant healthcare budget and health workforce implications. To alleviate this problem, different strategies including reinforce the importance of education and exercise are included; as previous studies showed that less than 40% of patients with KOA received non-pharmacological treatment, indicating that the uptake of evidence-based guidelines in clinical practice and rehabilitation is still suboptimal. Several literatures revealed that quadriceps and hamstrings strength exercise could effectively reduce pain. It has widely accepted that patients with end stage KOA will eventually pursue total knee replacement as the only viable option, and exercise has low efficacy in reduction of pain and disability in this group of patients. So, the investigators would like to know whether exercise therapy can help severe KOA patients


Eligibility Criteria:
Inclusion Criteria:

* Patients with end-stage knee osteoarthritis on queue for scheduling primary total knee replacement
* Completed 8-week course of physiotherapy program

Exclusion Criteria:

* TKR during the last 12 months
* Severe heart failure or neurological diseases affecting physical functions
Medical Marijuana Use in HIV+ Patients Prospective Cohort Study

The investigators are interested in understanding personal factors such as medical conditions and mental health, as well as social and economic factors, that influence marijuana (and other substance) use in HIV-positive patients.

Several alternative hypotheses will be evaluated in the proposed project:

1. healthier patients may self-select marijuana use;
2. marijuana use may be associated with consequences that create barriers to seeking healthcare;
3. marijuana use may have medicinal value that reduces the need for such care.

The study will involve a total of 5 interviews with clinical research staff members, the total involvement will be for about 1 year.

The first interview will establish a baseline of current behaviors and health status; this will take about 3-4 hours. This interview will take place at the Tolan Park Medical Building, located at 3901 Chrysler Service Dr. The remaining 4 interviews - which will be shorter in length - will be conducted about 3, 6, 9, and 12 months after the baseline interview; each follow-up interview will take about 2 hours.The purpose of the 4 remaining interviews is to assess changes in behaviors and health status over time.

We will collect urine samples at each of the 5 interview sessions to assess health and illicit drug use.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be patients in the HIV clinic.
* Participants will have HIV.
* Participants will sign a single consent form.
* Participants will be marijuana users.

Exclusion Criteria:

* Participants who test negative for marijuana will be excluded.
* Volunteers who exhibit signs of drug intoxication or cognitive/mental impairment during the consent process will be excluded.
EVALECGcardio Study

ECGs are routinely performed in cardiology. Recently handheld ECGs have shown promise in screening for heart rhythm disorders. These are quick to perform and do not require the preparation that is needed for 12 lead ECGs. We wanted to test whether a novel handheld ECG recorder, Kardia 6L, which has the potential to record a 6 lead ECG is able to screen for ECG abnormalities, thereby obviating the need for a full 12 lead ECG. This may allow for earlier diagnosis and treatment.

The aim of analysis is to determine if the handheld 6 lead ECG can be used as a simple screener to identify patients who do not need a 12 lead ECG.

Eligibility Criteria:
Inclusion Criteria:

* Anyone attending cardiology outpatients or the ward who has had a recent ECG (within 6 hours)

Exclusion Criteria:

* Patients who do not consent to the study