cyrilzakka/clinical-trials huggingface dataset:
A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour

This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058.


Eligibility Criteria:
Inclusion Criteria:

1. The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;
2. 18 to 75 years old (including both ends), gender is not limited;
3. Subjects with locally advanced or metastatic solid tumour confirmed by histopathology;
4. Having at least one evaluable or measurable lesion according to the solid tumour response Evaluation Criteria (RECIST 1.1);
5. ECOG Performance Status of 0 or 1;
6. The expected survival time is more than 3 months;
7. Be able to ingest drugs and be able to comply with trial and follow-up procedures;
8. Adequate bone marrow and organ function;
9. Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse) or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug. The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating;
10. For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception.

Exclusion Criteria:

1. Accompanied by untreated or active central nervous system (CNS) tumour metastasis;
2. Had other malignancies within five years prior to first use of the investigational drug;
3. With severe cardiovascular and cerebrovascular disease；
4. Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications;
5. The presence of uncontrolled pleural, abdominal or pericardial effusion;
6. Severe infection within 4 weeks prior to initiation of study treatment;
7. History of immune deficiency;
8. The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1;
9. Antitumor therapy such as chemotherapy, biotherapy, targeted therapy, immunotherapy, or other unmarketed investigational drug therapy within 4 weeks prior to initial use of the investigational drug;
10. Had undergone major organ surgery within 4 weeks prior to the first use of the study drug;
11. Women who are pregnant, breastfeeding, or who plan to become pregnant within one week of their last use of the study drug during the study period;
12. Known allergies and contraindications to the investigational drug or any of its components;
13. In the investigator's judgment, the subjects had other factors that could have affected the study results or led to the forced termination of the study.
Knee Genicular Nerve Ablation by Thermal Radiofrequency vs Thermal Radiofrequency Plus Alcohol Neurolysis

the aim of our study is to compare effectiveness (satisfaction) and duration of pain relief between patients receiving the conventional thermal radiofrequency on the genicular nerves alone vs patients who will receive the conventional method plus alcohol neurolysis of the targeted nerves.


Eligibility Criteria:
Inclusion Criteria:

1. Both genders.
2. Age between 60-70 years.
3. ASA 1,2 \& 3 physical status.
4. x ray imaging confirming the osteoarthritis and unwell or not candidate for knee replacement surgery

Exclusion Criteria:

1. Neurological disorders.(previous cerebrovascular stroke , neuropathy , or weakness )
2. coagulopathy ( plt \< 50000, INR \> 1.7 )
3. Infection at or near the injection site.
4. presence of pacemaker or defibrillator 5 - Acute knee injury.

6- age \< 60 or \>70 years
Effectiveness of Buccal Infiltration During Vital Pulpotomy After Administering Two Analgesic Premedications

This Randomized study was designed to assess and compare the effect of two analgesic premedications (Ibuprofen BP 100 mg/5 ml and Paracetamol 200 mg/5ml.) on the anesthetic efficacy of buccal infiltration in vital pulpotomy of primary mandibular molars in children . A multivitamin with the same color as the twp tested medications will be administered to children in the control group. Parents of eligible children will be informed about the nature of the procedure, the purpose of the study, any possible discomfort or risks and a signed informed consent will be obtained from them prior to enrollment.

A total of 60 healthy children will be recruited from the outpatient clinic of the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams University.

Inclusion Criteria include: age group 7-9 years Without systemic or mental disorders. Who could be categorized as cooperative according to Wright's classification for child behavior Ability of child to understand the use of pain scales; Having at least one lower second primary molar with deep caries indicated for pulpotomy; Absence of any periapical or furcation radiolucency on radiographs, Absence of any signs of internal or external resorption on radiographs, A vital coronal pulp on access opening.

. Patients who had taken analgesics within 12 hours before administration of the study drugs or those having active pain, pulpitis or abscess related to the designated mandibular molar will not be included.

To ensure randomization and allocation concealment, children will be randomly assigned to the three groups using computer-generated numbers.

One operator will do pulpotomy for all participants and to ensure blinding, another author ( will give the premedication to children.Pain during pulpotomy will be assessed using Wong Baker FACES pain assessment tool.

Eligibility Criteria:
Inclusion Criteria:

1. age group 7-9 years
2. Patients medically free.
3. Patients who can be categorized as cooperative or potentially cooperative according to Wright's classification for child behavior
4. Patients able to understand the use of pain scales;
5. Having at least one lower second primary molar with deep caries indicated for pulpotomy;
6. A vital coronal pulp on access opening of designated molar.

Exclusion Criteria:

1. Patients with allergic reactions, sensitivity, or contraindications to any tested drugs
2. Patients who had taken analgesics within 12 hours before administration of the study drugs
3. Patients having active pain, pulpitis or abscess related to the designated mandibular molar.
4. Children with special health care needs or any systemic problems
5. Presence of periapical or furcation radiolucency on radiographs in relation to designated molar
6. Presence of of any signs of internal or external resorption on radiographs in relation to designated molar
Appendectomy and Colorectal Cancer

Colorectal cancer (CRC) is one of the most common cancer worldwide. Initiation and progression of CRC involve complex interactions among genetic, epigenetic and environmental factors. Given that hereditary and familial CRC only accounts for 2% to 5% of cases, environmental factors are the key triggers of CRC. Emerging evidence has indicated that gut microbes are an important environmental factor promoting CRC development. Gut dysbiosis has been shown to promote colorectal carcinogenesis in mice. Several individual bacterial species, such as the enterotoxigenic Bacteroides fragilis (ETBF), Fusobacterium nucleatum and Peptostreptococcus anaerobius, could exert carcinogenic effects by inducing direct DNA damage, oxidative damage and activating oncogenic signaling pathways. Recent studies have shown that the appendix plays an important role in maintaining homeostasis and biodiversity of gut microbiome by providing an ideal ecological niche for commensal bacteria and production of immunoglobulin A. Considering the key role of microorganisms in gastrointestinal pathophysiology, absence of appendix may result in disruption of microbiome homeostasis, which could potentially influence the risk of developing CRC. In terms of epidemiological evidence, the association of appendectomy with the risk of CRC development has been controversial, and to date no consensus has been attained. Although gut microorganisms could be a crucial pivot between appendectomy and risk of subsequent CRC development, the direct contribution of appendectomy and the underlying mechanisms are still largely unexplored. In this study, we aim to study

1. the association between appendectomy and colorectal cancer, and
2. the role of appendectomy in CRC risk through causing gut microbial dysbiosis.


Eligibility Criteria:
Inclusion Criteria:

* Individuals underwent appendectomy from January 2000 to December 2020

Exclusion Criteria:

1. patients with the age ≤18 years at enrollment;
2. Patients with any malignant diseases or inflammatory bowel disease history before enrollment;
3. Patients with hereditary syndromes of colorectal adenomas or polyps (familial adenomatous polyposis, Lynch syndrome, etc.);
4. Patients that underwent appendectomy for appendiceal neoplasms.
Predictive Factors of the Treatment Failure in Hepatitis C Virus (HCV) Infected Patients Treated With Telaprevir

The purpose of the study is to

1- detect and quantify HCV-PI resistant mutants with ultra-deep pyrosequencing (UDPS) technology, 2 - detect SNPs in P-glyocoprotein and CYP3A genes, in HCV mono-infected patients under/after Telaprevir treatment.


Eligibility Criteria:
Inclusion Criteria:

* HCV mono-infected subjects
* Age \> 18 years

Exclusion Criteria:

* HBV co-infection
Nutritional Status in Subacute Stroke Patients Under Rehabilitation 2.0

The Nutristroke study's findings revealed a malnutrition scenario in post-stroke patients undergoing rehabilitation. This has highlighted the significance of a correct nutritional status assessment upon admission to a rehabilitation unit.

The aim of Nutristroke2, therefore, is the assessment of nutritional status, dietary intake, dysphagia, the presence of stroke-related sarcopenia, and systemic oxidative status in patients with subacute stroke outcomes before and after rehabilitation treatment.

A secondary aim is to assess whether there is any correlation between nutritional status, dietary intake, dysphagia, sarcopenia, and systemic oxidative status with rehabilitation outcomes.


Eligibility Criteria:
Inclusion Criteria:

* stroke patients (hemorrhagic or ischemic) documented through Magnetic Resonance -Imaging (MRI) or Computed Tomography (CT);
* time since stroke event within 6 months
* sufficient cognitive and language skills to understand the instructions related to the administration of the assessment scales and to sign informed consent

Exclusion Criteria:

* presence of a previous stroke based on the medical history;
* behavioral and cognitive disorders that may interfere with the therapeutic activity;
* other orthopedic or neurological complications that may interfere with the rehabilitation protocol;
* inability to understand and sign informed consent;
* the presence of pacemakers (for interference with bioimpedance measures).
Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy

OBJETIVE: To study the influence of musicotherapy in reduction of fatigue related to cancer in patients with breast's or gynecology's cancer, during the radiotherapy treatment.

METHODS: This is a randomized controled study (Control Group - CG e musicotherapy Group - MTG) wich values fatigue, life's quality, anxiety, depression by using evaluative instruments Functional Assessment of Cancer Therapy: Fatigue (FACT-F), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) in three different moments (during first week of radiotherapy, in the intermediate phase's week and during the last week of radiotherapy) for patients of both groups. Women allocated in MTG, in addition to the scales described above, answered the musicotherapy Questionary (MQ), and the Subjective Impression of the Subject's Questionary in last meeting. Musicotherapy sessions were individual and lasted an average of 40 minutes. Music therapeutic techniques used were Musical Audition (MA) and Therapeutic Musical Audition (TMA).

Eligibility Criteria:
Inclusion Criteria:

* Patients with breast and gynecological cancer with indication for radiotherapy
* Performance status 0,1

Exclusion Criteria:

* Hemoglobin \< 10mg/dl
* Patients in psychotherapy during the study
* Use of antidepressants
* Patients presenting more than one cancer type
Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis

Primary Objective:

To describe the safety and tolerability, including laboratory abnormalities following a single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in Japanese patients with rheumatoid arthritis (RA).

Secondary Objectives:

To describe the laboratory abnormalities (absolute neutrophil count \[ANC\], platelet counts, total cholesterol, high-density lipoprotein \[HDL\] cholesterol, low-density lipoprotein \[LDL\] cholesterol, and liver function tests \[LFTs\]) following a single dose of sarilumab or tocilizumab administered SC as monotherapy in Japanese patients with RA.

To describe the pharmacokinetics (PK) of sarilumab and tocilizumab.

Total study duration (per patient) is expected to be up to 71 days including screening (3 to 28 days before dosing).

Eligibility Criteria:
Inclusion criteria:

* Patients with rheumatoid arthritis (RA) as defined by the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010
* Rheumatoid Arthritis Classification Criteria.
* ACR Class I-III functional status, based on the 1991 revised criteria.

Exclusion criteria:

* Patients less than 20 years of age.
* Prior treatment with any biologic anti-interleukin-6 (anti-IL-6) or interleukin-6 receptor (IL-6R) antagonist.
* Any parenteral or intraarticular glucocorticoid injection within 4 weeks prior to randomization.
* Treatment with prednisone higher than 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.
* Treatment with disease-modifying antirheumatic drugs (DMARDs), immunosuppressive agents, tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents within a certain amount of time prior to randomization.
* Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer.
* Active or suspected tuberculosis (TB) or at high risk of contracting TB.
* Fever, or chronic, persistent, or recurring infection(s) requiring active treatment.
* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Medical and Surgical Management of Patients With Brain Metastases

The integrated cancer research site (SIRIC) of Montpellier proposes to develop a prospective and regional Clinical Database Project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient's management with brain metastases including quality of life and neuropsychological/cognitive aspects.

Brain metastases (BM) represent the first cause of tumors of the central nervous system. Mortality, morbidity (cognitive disorders, neurological deficits, etc.) and their consequences on the quantity and the quality of life are very high. BM represent a real public health problem. The incidence is increasing related to the ageing of the population and the increase of cancer patient's survival rate. The medico-surgical care has highly evolved (neurosurgical progress, radiosurgery, stereotaxic radiotherapy and new chemo and targeted therapy).

Every histological or biological profile requires a specific evaluation, and management. Clinical trials are the reference to establish the efficacy and the toxicity of the new processes, but usually answer only at a single question and for very selected patients.

For this reason, the SIRIC Montpellier Cancer proposes to develop a prospective and regional Clinical Database Project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient's management with brain metastases including quality of life and neuropsychological/cognitive aspects.

Eligibility Criteria:
Inclusion Criteria:

1. Adult ≥ 18 years
2. Radiological diagnosis of brain metastases
3. Patient eligible for neurosurgical exeresis or treatment by radio-surgery
4. Patient treated in a neurosurgery center of the Languedoc-Roussillon region (whatever therapeutic treatment realized on primary tumor)
5. Present brain metastases not previously treated
6. Signed informed consent
7. Patient affiliated to a national insurance system or beneficiary of such a system

Exclusion Criteria:

1. Patient with primary brain tumor
2. Impossibility to be regularly monitored for psychological, family, social, or geographical reasons
3. Subject under guardianship
Effects of Virtual Reality-Based Balance Training Compared to Conventional Balance Training to Reduce Risk of Fall in Patients With Diabetic Peripheral Neuropathy: A Randomized Control Trial

The objective of this study is to determine the effects of virtual reality based balance training compared to conventional balance training to reduce risk of fall in patients with diabetic peripheral neuropathy in terms of fall and gait parameters.

The study is a non-blinded randomized control trial, consisting of 2 groups. The Study will be conducted at Fauji Foundation Hospital and Foundation University Islamabad. A calculated sample of 30 subjects will be selected via non-probability convenience sampling technique followed by randomization into two groups using envelope method.

After CBRC registration, ethical approval is obtained from ERC FUMC. Individuals fulfilling the inclusion criteria is selected, followed by written informed consent after explaining the study purpose.

Participants is then be randomly allocated to one of the 2 groups. At the baseline, Fall Efficacy Scale (FES), Activity-specific Balance Confidence (ABC), Time Up and Go Test and Dynamic Gait Index (DGI) are assessed.

Control group is provided with conventional balance training. Treatment group is provided with the Virtual Reality (Wii Fit) Based Balance Training.

Exercise training is performed thrice a week on alternate days for a total duration of 18 sessions over 06 week.

All outcome measurements would be performed before and then after the 6-weeks intervention period.

Data will be entered and analyzed on SPSS v. 22.


Eligibility Criteria:
Inclusion Criteria:

* Age: 40 years and above
* Medical Diagnosis of diabetes under regular medication control and Diabetic Peripheral Neuropathy (DPN) confirmed
* Independent community ambulatory individuals
* Intact cognition (MMSE \> 24)

Exclusion Criteria:

* Other neurological conditions I.e. Dementia, Parkinson Disease, Spinal Cord Injury or Stroke.
* Severe visual impairment, Musculoskeletal disorders, Unhealed plantar ulceration, Lower limb amputation, poor cardiopulmonary function or other disease that affects walking ability or any other disease due to which individuals are unable to walk without assistance.
* Any other condition associated with high risk of fall.
* Inability to follow simple instructions.
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects

This study is an open-label extension of RFSP-AMDX-2010 study for those subjects who received treatment with amdoxovir (300 mg or 500 mg twice daily) for 12 weeks and benefited from it. This study will examine the safety and efficacy of the investigational HIV drug, amdoxovir (300 mg and 500 mg bid doses; N = up to 30) in combination with zidovudine and lopinavir/ritonavir for 36 weeks.

Subjects will continue to receive either amdoxovir 300 mg twice daily or amdoxovir 500 mg twice daily, each in combination with zidovudine 300 mg twice daily and lopinavir/ritonavir (400 mg/100 mg twice daily) for additional 36 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Must have completed Study RFSP-AMDX-2010 and received treatment with amdoxovir (500 mg bid or 300 mg bid) for 12 weeks before entry into study RFSP-AMDX-2012.
* Must have maintained ≥ 1.0 log10 copies/mL from baseline at Week 12 in Study RFSP-AMDX-2010.
* Must not have had any serious adverse experience since enrollment in Study RFSP-AMDX-2010, whether or not considered to be study drug-related.

Exclusion Criteria:

* Subjects who require ongoing therapy of nephrotoxic drugs or competitors of renal excretion.
* Subjects who require therapy with hematologic, bone marrow suppressive or cytotoxic agents.
* Subjects who require medications that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with life-threatening adverse events.
* Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations.
* Women who are pregnant or breastfeeding.
Multi-omics to Predict Responses to Biologics in IBD

Inflammatory bowel disease (IBD) is a chronic immune-related disease, which mainly affects the digestive tract. There are mainly two forms of the disease, including Crohn's disease (CD) and ulcerative colitis (UC).

Biologics have revolutionized the treatment of inflammatory bowel disease with good efficacy and safety. However, 20-50% of patients may not response to or lose response to biologics. Unfortunately, there has been no factors or measures that may predict the efficacy or safety of biologics.

In this study, a large prospective cohort study is conducted to evaluate the efficacy and safety of biologics (infliximab, adalimumab, vedolizumab, ustekinumab, and other approved biologics) in patients with inflammatory bowel disease in the real clinical practice. Meanwhile, a multi-omics approach involving transcriptomics, microbiome, proteomics, and metabolome, are adopted to explore biomarkers or factors that predict the therapeutic efficacy or safety of biologics. The mechanism underlie the disease will also be explored.


Eligibility Criteria:
Inclusion Criteria:

1. For patients with IBD:

   * Patients with IBD treated with approved biologics
   * Age 18 or over
   * Written informed consent obtained from patient for participation
2. For non-IBD healthy volunteers:

   * Patients without the diagnosis of IBD or other conditions that, in the opinion of the investigator, not suitable to participate in the study
   * Age 18 or over
   * Written informed consent obtained from patient for participation

Exclusion Criteria:

* Unable to obtain written informed consent
* Patient is, in the opinion of the investigator, not suitable to participate in the study