cyrilzakka/clinical-trials huggingface dataset:
Laser Therapy Effect on Oral Mucositis in Childhood Acute Lymphoblastic Leukemia Patients

Introduction: Oral mucositis is one of the most frequent complications associated with chemotherapy, occurring in up to 90% children receiving treatment for cancer. Different treatment modalities have been suggested with inconsistent results. Recently, it has been suggested that the use of laser could reduce the grade of oral mucositis and alleviate the symptoms.

Aim: To evaluate and compare the efficacy between the high (Infrared) wavelength laser and low (red) wavelength laser in management of chemotherapy induced oral mucositis in children with acute lymphoblastic leukemia.

Methods: This study is a randomized, prospective, double-blind trial that will include acute lymphoblastic leukemia inpatients receiving induction chemotherapy between the age of 3 and 14years who develop oral mucositis grade 2 or more. These patients will be randomized by the Clinical Epidemiology unit using a computer-based method into three groups. Group I: will be treated with Laser wavelength 660 nm, group II: will be treated with laser wavelength 970 nm, and group III: will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission. All the patients will follow the hospital standard management for oral mucositis. All patients will be assessed for pain score using CHIMES, oral mucositis using NCI-CTCAE scale V5 on days, 0,4,7 and 11. As well as measuring the duration of the lesion.

This study is a randomized, prospective, double-blind trial that will include acute lymphoblastic leukemia inpatients receiving induction chemotherapy between the age of 3 and 14 years who develop oral mucositis grade 2 or more. These patients will be randomized by the Clinical Epidemiology unit using a computer-based method into three groups.

Group I: will be treated with Laser wavelength 660 nm, Group II: will be treated with laser wavelength 970 nm, Group III: will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission.

All the patients will follow the hospital standard management for oral mucositis.

All patients will be assessed for

1. Pain score using CHIMES,
2. Oral mucositis using NCI-CTCAE scale V5 on days, 0,4,7 and 11.
3. Measuring the duration of the lesion.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Acute Lymphoblastic Leukemia in the induction therapy phase and have oral mucositis grade 2 or more.
2. Age: 3-14 years old of both genders.
3. No previous treatment with laser.
4. Ability to open mouth for more than 2 cm for the duration of laser application with a level of cooperation (Frankl rating 3 or 4).
5. Patients who still have 10 days in their induction therapy phase or can be followed up for a mininum of 10 days after the development of oral mucositis

Exclusion Criteria:

1. Patients receiving radiotherapy
2. Received oral Cryotherapy or IV keratinocyte growth factor for oral mucositis
3. Patients with unstable clinical condition (e.g. sepsis)
4. Patients who will be withdrawn from participation according to their request or due to loss in follow up
Total Knee Replacement With the ROCC Knee

The purpose of this study was to assess the results of a Total Knee prosthesis specifically intended to enhance functional performance , especially in terms of physical and sports activity.

Clinical and radiographic results , complications, early post-operative and late functional outcome and survivorship were studied in a continuous prospective series of 500 patients ( 602 knees) managed using the ROCC knee ( BIOMET INC - Warsaw- IND, USA).

A minimum follow-up of 5 years was required.

Eligibility Criteria:
Inclusion Criteria:

* all patients receiving a total knee

Exclusion Criteria:

* patients with severe psychiatric, neurologic, cardiologic or locomotor pathology occuring after the total knee replacement
Iatrogenic Drug Risk in People Over 75, With or Without Cognitive Disorders, From an Inventory of Their Family Pharmacy

Many hospitalizations or emergency room visits are due to problems of iatrogenic medication, especially in elderly patients who are very often polymedicated. Moreover, they are more at risk because of fragility. This has an important socio-economic impact. It therefore seems important to act upstream of these adverse events and a review of the drugs available in the homes of elderly patients seems a good starting point.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 75 years with or without cognitive disorders

Exclusion Criteria:

* Refusal to participate
Physiotherapy Program for Breast Cancer Women Following Surgery: A Pilot Clinical Trial

pilot study on physical therapy in women with breast cancer immediately following surgery

A pilot, single-arm non-randomized clinical trial was conducted between the period September 2018 and June 2019 on a convenient sample of BC women. Primary study outcomes were pain, disabilities of the Arm, Shoulder, and Hand (DASH), handgrip strength, and quality of life (QoL). The secondary outcome was to assess the feasibility of this pilot study. All outcomes were recorded at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90) under standardized conditions. The interventions were delivered by the physiotherapist early within 24 hours post-operatively, T1, and T2. In addition, home-based exercise was provided with written instructions during hospitalization with rehearsal sessions to ensure the patient's understanding and compliance

Eligibility Criteria:
Inclusion Criteria:

* women with breast cancer who require surgical resection

Exclusion Criteria:

* in ability to undergo 3 months of physical therapy program
Irreversible Electroporation (NanoKnife ®) and Immunotherapy for the Treatment of Stage IV Colorectal Cancer

The goal of this pilot clinical trial is to learn about the combination of immune boosting drugs and irreversible electroporation (IRE) in patients with colon cancer that has spread to the liver (metastasis). The main questions it aims to answer are:

1. to document the rate of complications associated with combining IRE with immune boosting drugs.
2. After one liver metastasis is treated with IRE and immune boosting drugs, what is the change in the size of the non-IRE-treated liver metastases?
3. What is the immune response (measured in a blood sample) when IRE is combined with one or two types of immune boosting drugs?

Single-centre pilot study of the use of IRE for the treatment of 12 patients with unresectable colorectal liver metastases to assess feasibility and gain preliminary data to inform the design of a larger study.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy-proven colorectal liver metastases with at least one measuring \< 3.5 cm in diameter and accessible to percutaneous IRE such that a complete ablation of the lesion is possible.
2. Prior resection of the colorectal cancer primary.
3. The imaging has been reviewed in multi-disciplinary Rounds and the colorectal liver metastases have been deemed unresectable.
4. Patient has undergone chemotherapy and has not converted to resectable disease.
5. Radiologic evidence of stable disease for at least two months on systemic therapy for colorectal cancer (may have had prior partial response or disease progression)
6. Microsattelite instability (MSI)-stable or mismatch-proficient tumors
7. Patient has HLA phenotype of Human Leukocyte Antigen (HLA) A1 or HLA A2.
8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Size of the metastasis being treated with IRE \> 3.2 cm or \< 2 cm.
2. Size of any non-IRE-treated liver metastasis \> 4 cm
3. Pregnancy
4. Major comorbid disease
5. Active autoimmune disease
6. Bone or brain or peritoneal metastases.
7. MSI High disease
8. Patients with cardiac arrhythmia other than rate controlled atrial fibrillation.
9. Metal implant that cannot be removed within 10 cm of the area to be treated.
10. Peritoneal disease.
11. Poor performance status
12. Cirrhosis
Unravelling Intestinal Fibrosis in Ulcerative Colitis

The main objectives are: (i) to identify candidate fibrotic cellular pathways in UC patients treated with a JAK inhibitor filgotinib), and (ii) to detect and monitor in vivo fibrosis in UC patients using FAPi-PET/CT imaging


Eligibility Criteria:
Inclusion Criteria:

* Adults with confirmed diagnosis of UC - Group 1 criterion: ≥18 years of age regardless of gender
* Group 2 criterion: ≥30 years of age for males and ≥40 years of age for females
* Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2)
* Indication to start treatment with filgotinib

AND one of the following criteria:

* Active disease confirmed by intestinal ultrasound (BWT \&gt; 3 mm in at least one bowel segment and at least one other pathological IUS parameter) or
* Increased CRP (\&gt;5 mg/L) and/or fecal calprotectin levels (\&gt;250 mg/kg)

Exclusion Criteria:

* Pregnancy
* Unable to provide informed consent
* Colorectal carcinoma or high-grade dysplasia
Evaluation of a New Biocompatible Pressure Equalizing Tube

Otitis media is the most common illness in children and 5% to 10% of their symptom cause by fluids in their middle ear . The OME can cause hearing loss included poor development of speech and poor communication.

The surgical procedure is considered simple and relatively safe, but several complications may occur after Pressure Equalizing tube insertion. The most prevalent complications are otorrhea, biofilm and formation of retraction pockets. Otorrhea occurs in 30% to 83% of children with tube and is mainly due bacterial contamination of the middle ear either from external ear canal or impaired Eustachian tube. Swimming can facilitate the entry of bacteria into the middle ear from the ear canal through the PE tubes, and this assumption is reinforced by the statistically significant association between the rate of otorrhea and the non-utilization of ear plugs in children who swim (from 47% in children who used ear plugs to 56% in those who did not).

The researcher at Beckman Laser Institute, University of California, Irvine, develops new medical tool device call biocompatible Pressure Equalizing tube which can stop air passage and pressure equalization instantly, and can prevents water into the middle ear cavity. evaluate and compare the efficacy of a biocompatible Pressure Equalizing tube that enables air passage and pressure equalization almost instantly, while prevents the entrance of fluids, specially water, into the middle ear cavity.

The biocompatible Pressure Equalizing tube can reduce the rate of postoperative otorrhea,air passage between outside and middle ear cavity,prevents formation of retraction pockets in TM and swimming with lower risk of otorrhea.

Eligibility Criteria:
Inclusion Criteria:

1. Male/ female at all age- newborn to adult.
2. Non- pregnant woman.
3. Diagnose of middle ear infection and plan for surgery procedure

Exclusion Criteria:

1. Pregnant woman
2. Incompetent adults (i.e. individuals with cognitive impairment)
3. Presence of immunodeficiency; cystic fibrosis; sickle cell disease;
4. Another major systemic disease
5. Congenital malformation of the external, middle, or inner ear
6. Sensorineural hearing loss; otoneurologic disease
7. History of prior ear surgery such as tympanoplasty, tympanomastoidectomy, or mastoidectomy; cholesteatoma; chronic mastoiditis; intratemporal or intracranial suppurative complications of otitis media
8. Use of ototoxic medication (except topical use)
Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (\< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to antibiotic prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* term (≥ 37+0 weeks) singleton pregnancy
* a vertex presentation
* ruptured membranes for less than 12 hours
* negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks

Exclusion Criteria:

* active labor
* absence of GBS culture or indication for GBS antibiotic prophylaxis (such as maternal GBS colonization between 35 and 37 weeks, GBS bacteriuria, prior infant with GBS sepsis)
* contraindication to expectant management (such as fetal distress, meconium staining of the amniotic fluid or chorioamnionitis) or to vaginal delivery
Study in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium

This observational study will document to what extent in daily clinical practice the work productivity is affected before and after the start of adalimumab treatment.

Changes in the employment status and work productivity of participants with AS and PsA before and after the start of adalimumab will be noted. The relationship between employment status, work productivity, disease activity and clinical evaluations will be evaluated. Since AS and PsA might be diseases with a strong impact on the daily life of the participant, an evaluation will be performed to the effect of the disease on quality of life and work productivity.


Eligibility Criteria:
Inclusion Criteria:

* Patient \>= 18 years and \<= 50 years
* Patient diagnosed with AS or PsA
* Patient to be initiated on adalimumab (according to the Marketing Authorization and Belgian reimbursement criteria)
* Patient willing to sign informed consent

Exclusion Criteria:

* Any contraindication for adalimumab as specified in the corresponding Summary of Product Characteristics (SmPC)
* Patient previously treated with biologics
* Patient participating in other AbbVie-sponsored trials
A Spatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs

Conduct a study of people who use drugs (PWUD) perceptions of and access to COVID-19 vaccines as well as reasons for vaccine hesitancy/barriers

Conduct a qualitative rapid longitudinal assessment of 20 PWUD's perceptions of and access to COVID-19 vaccines as well as reasons for vaccine hesitancy/barriers. The investigators will also assess frequency and content of COVID-19 communication with peers. The investigators will also assess changes in the social network dynamics of drug use and access to illicit drugs, drug treatment, and HIV care. The brief qualitative interviews will be conducted biweekly over a period of one year. These interviews will be quickly transcribed, summarized, and provided to local and state health departments. The investigators will also use the findings from this aim to inform the proposed app and peer education pilot outlined in aims 2 \& 3.

2. Development of an app provide real-time information on COVID-19 vaccine availability and nearby risk reduction resources (naloxone distribution sites, syringe exchanges, drug treatment). The app will be built for mobile download and as an online webpage. 20 PWUD will be included in this study component, split between the mobile and web-based app.

3. Develop training materials and pilot the training of 40 PWUD to promote vaccine uptake among the participants network and other community members. PWUD will be trained to become peer educators to promote COVID-19 vaccine uptake over 4 sessions. These 40 participants will be administered pre- and post-surveys as well as daily check-in questions through the app to assess effectiveness as peer educators.

Eligibility Criteria:
Inclusion Criteria:

* opioid use in prior 2 weeks

Exclusion Criteria:

* none
Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia

Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia cases.

Vitamin D3 has key role in decidualization and implantation of placenta.Vitamin D deficiency is thought to have positive association with pre-eclampsia.Vitamin D deficiency is highly prevalent in some parts of the world and it is not universally screened antenatally. Pre-eclampsia is a known multifactorial pregnancy disorder with significant maternal and perinatal morbidity and mortality. Vitamin D3 has a down-regulating effect on inflammatory pathways and reducing endothelial cell damage.

Investigators want to assess in vitamin D deficient group whether treatment reduces the risk of pre-eclampsia.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed singleton pregnancy of less than 13 completed weeks of gestation at the time of consent.
* Planned to receive antenatal care in King Fahad Medical City antenatal clinic.
* The ability to provide written informed consent at the first visit.
* Low risk pregnancy; and Serum vitamin D3 levels less than \< 25nmol/L.

Exclusion Criteria:

* Mothers with pregnancy with abnormal foetus.
* Previous history of hypertension, pre-eclampsia, recurrent miscarriages.
* Chronic kidney disease, chronic liver disease, and malignancy.
Multi-omics Studies of Host-microbiome Interaction in Chronic Obstructive Pulmonary Disease and Bronchiectasis

Chronic obstructive pulmonary disease (COPD) and bronchiectasis are common chronic respiratory diseases in China. COPD is characterized by irreversible lung function decline due to airway inflammation, emphysema and alveolar destruction. Bronchiectasis is characterized by permanent bronchiectasis, its main clinical symptoms are cough, dyspnea, hemoptysis and recurrent respiratory tract infections. The incidence and prevalence of bronchiectasis have assumed continuously grows in global. Airway microbiota, whose alterations play an important role in the occurrence and development of bronchiectasis, form a complex ecosystem interacted with host cells and various biotic and abiotic factors in the microenvironment. Additionally, mounting evidence suggests that the airway microbiome is associated with COPD phenotypes and endotypes, and that dysbiosis contributes to airway inflammation. However, the mechanisms remain poorly understood, owing to limited knowledge of microbial functional properties, metabolic activities and cross-talk with the host immune system. The investigators aim to collect sputum specimen and perform multi-omic analysis on patients with COPD and bronchiectasis in seven clinical centres in China.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with bronchiectasis (according to the Chinese consensus, patient's previous chest CT examination must show bronchiectasis) or COPD (according to GOLD 2022).
* Patients with age ≥18 years old.
* Written informed consent.

Exclusion Criteria:

* Pregnancy or lactation, or those without taking effective contraceptive measures
* Subjects with a history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders
* Subjects with a history of alcohol or illicit drug abuse
* Subjects with any of the following pulmonary diseases: active tuberculosis, pulmonary embolism, pneumothorax, multiple huge bullae, uncontrolled asthma, acute exacerbation of chronic bronchitis or extremely severe COPD
* Diagnosis of chronic gastrointestinal disease, heart disease, diabetes, severe renal insufficiency (GFR \< 30ml/min) or immunodeficiency
* Participated in any interventional clinical trial within 3 months before enrolment.
* Poor compliance or inability to cooperate as judged by the doctor
Testing Radical Prostatectomy in Chinese Men With Prostate Cancer and oligoMetastases to the Bone

This study is to examine whether radical prostatectomy can impact survival and quality-of-life in men with oligo-metastatic prostate cancer.

In this study, patients with oligo-metastatic prostate cancer will be randomized to radical prostatectomy plus standard care and standard care only. Standard care refers to androgen deprivation therapy (ADT) +/- other systemic therapies. Time to disease progression and post-treatment quality of life will be assessed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Participants is willing and able to give informed consent for participation in the study
* Male aged 19-75 years.
* Diagnosed with oligo-metastatic prostate cancer (1-3 skeletal lesions on bone specific imaging, no visceral metastases).
* Locally resectable tumor (clinical/radiological stage T1-T3).
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Suitable for radical prostatectomy within 12 months of starting standard care.

Exclusion Criteria:

* Contraindications to radical prostatectomy.
* Visceral metastases.
* Prior radiotherapy to the abdomen/pelvis or to skeletal metastases.
* Any systemic therapy of prostate cancer (including standard care) for 12 or more months prior to enrollment.
* Current involvement in other interventional research.
Subjective Sleep and Fatigue During and After Acute Diverticulitis

The purpose of this study is to investigate subjective sleep quality and fatigue during and after Acute uncomplicated diverticulitis assessed by questionnaires and a sleep-diary. The investigators hypothesis is that subjective sleep and fatigue are correlated with the inflammatory activities.

An increasing number of experimental studies have showed that inflammation can induce disturbances in sleep architecture, mediated by cytokines. some studies showed that cytokines also induce daytime fatigue. In this study the investigators aim to describe the patient experiences of sleep and fatigue during the acute inflammation and the recovery, and the investigators seek to exam the correlation of fatigue with Polysomnography-measured night sleep and cytokine levels in plasma.

Following methods will be applied

* Other: Karolinska Sleepiness Scale
* Other: Physical Fatigue Scale
* Other: Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain
* Other: Sleep-diary
* Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)
* Procedure: Plasma cytokines (IL-2, IL-6 and TNF-alfa(tumor necrosis factor))
* Procedure: Plasma CRP(C reactive protein) and leukocytes
* Device: Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA

Eligibility Criteria:
Inclusion Criteria:

* CT-verified diverticulitis patients managed by antibiotic treatment at Herlev Hospital
* Pain and fever occurred less than 72 hours prior to the admission
* ASA (American Society of Anesthesiologists) score I to III

Exclusion Criteria:

* Surgical intervention needed
* Complicated diverticulitis
* Complications in relation to diverticulitis
* Pain and fever occurred more than 72 hours prior to the admission
* In anticoagulant treatment and heart rate control treatment
* Known Autoimmune disease
* Known medically treated sleep-disorder (insomnia, restless legs etc.) and sleep apnea
* Shift-work or jetlag
* Daily use of opioid, psychopharmaca, opioids or anxiolytics (including Hypnotics)
* Known psychiatry conditions in treatment with psychopharmaca
* Daily alcohol intake of more than 5 units or drug abuse
* Missing written consent
* Diabetes Mellitus
* Predicted bad compliance
* Pregnant or breast-feeding
* Urine or fecal incontinence
* Severe kidney disease
* Current cancer
Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus (INPH)

This study aims to provide class 1 evidence supporting or refuting the existence of normal pressure hydrocephalus.

By comparing one group with active CSF shunting with another with non .

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Normal pressure Hydrocephalus

Exclusion Criteria:

* Alzheimer disease
* Vascular dementia