cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer

The aim of this study was to develop an radiomic model based on CT images to evaluate markers of the bladder cancer microenvironment, such as TSR,TIL, and IP. Secondly, the association of the radiomic model with clinical outcomes and immunotherapy response was investigated.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age;
2. Performing TURB-t or RC during 2010-2022;
3. The primary lesion was located in the bladder, and the pathological diagnosis was urothelial carcinoma;
4. Complete clinical information, pathological data, preoperative pelvic enhanced CT and follow-up records;

Exclusion Criteria:

1. Patients with distant metastasis;
2. Combined with other malignant tumors or malignant tumor treatment history
3. Malignant tumors of upper urinary tract;
4. Clinical information, pathological data, preoperative pelvic enhanced CT and follow-up records were missing;
5. Other situations in which the researcher considers it inappropriate to participate in this study.
Regeneration of Knee and Ankle Cartilage from Autologous Cartilage Mini-grafts (from the Patient's Own Cells)

The purpose of this study is to investigate the safety and feasibility of implanting autologous cartilage mini-grafts (or Cartibeads) into cartilage defects in the knee and ankle.

Cartibeads are engineered from autologous articular chondrocytes (from the patient's own cartilage cells). A small cartilage biopsy (\~50 to 150 mg according to lesion size to be treated) is collected from a minimal weight bearing zone of the patient's articulation. Chondrocytes are extracted from the biopsy and expanded in culture. Our patented, standardized methodology then allows expanded cells to recover their capacity of producing hyaline matrix and to form cartilage mini-grafts (Cartibeads). These grafts are beads of 1 to 2 mm in diameter and have similar characteristics to native hyaline cartilage.

Autologous Cartibeads are implanted into the patient's cartilage defect. Patients are then followed for 12 months for assessment of study endpoints, with safety being the primary outcome.


Eligibility Criteria:
Key inclusion criteria:

* Cartilage focal lesion(s) ≥ 1.5 cm2 and ≤ 10 cm2
* ICRS grade 3 or 4
* Pain for 3 months or more
* Aged over 18 years

Key exclusion criteria

* Inability to undergo MRI
* Cartilage specific surgery within 12 months from baseline
* Cartilage therapeutic injection within 3 months from baseline
* Radiologically apparent degenerative joint disease (K\&L grade \>1)
* Chronic inflammatory arthritis and/or infectious arthritis
Retinal Vessel Leakage in Cerebral Small Vessel Disease

The goal of this observational study is to learn about leakage from retinal vessels in cerebral small vessel disease. The main questions it aims to answer are:

* Does retinal vessel leakage occur in cerebral small vessel disease?
* If it does, is the severity of retinal vessel leakage similar to the severity of cerebral small vessel disease generally?

Participants will be tested using fluorescein angiography. This involves an intravenous injection of fluorescent dye, and is a very sensitive way to find leakage from retinal blood vessels.

Participants will have already had brain scans and other examinations and tests to measure the severity of their cerebral small vessel disease. Our new retinal images will complement the information from these previous tests.

Cerebral small vessel disease (SVD) is a common cause of stroke and dementia. The molecular causes are unclear, limiting new therapies. Breakdown of the blood-brain barrier (BBB) is characteristic and may damage brain tissue. However, specialist MRI scans to measure BBB breakdown are expensive and time-consuming.

In contrast, measuring leakage from retinal blood vessels is relatively simple. The blood-retina barrier is very similar to the BBB, and SVD is likely to damage retinal and brain blood vessels in the same way. If so, then retinal angiography could be used to study SVD pathogenesis and measure the effect of new treatments with much greater resolution and lower cost than MRI.

We have three aims:

1. Test the feasibility of fluorescein angiography in people with SVD
2. Discover if retinal vessel leakage occurs people with SVD
3. Discover whether the severity of retinal vessel leakage is associated with clinical features of SVD

We will recruit participants from a well-established cohort of people with SVD - the Mild Stroke Study 3 (MSS3).

Eligibility Criteria:
Inclusion Criteria:

* Membership in the Mild Stroke Study 3 cohort
* Contrast enhanced MRI within 12 months
* Clear optical media in both eyes, as assessed by study investigator
* Best corrected visual acuity (near vision) ≥N36

Exclusion Criteria:

* Any condition known to cause retinal leakage (i.e., worse than background diabetic retinopathy, retinal vein occlusion, active uveitis, wet age-related macular degeneration, malignant hypertension)
* Previous treatment for retinal leakage (retinal laser, intravitreal anti-VEGF)
* Recent eye surgery
* Shallow anterior chambers as assessed by torch test
* Pregnancy, renal failure
* Severe dementia
* Known allergy to fluorescein
* History of allergy such as food or drug induced urticaria or history of bronchial asthma
* Any other severe or acute medical or psychiatric conditions
* Inability to give informed consent
WTX212A Monotherapy and in Combination With PD -1/PD-L1 Monoclonal Antibody

This trial is a single-center, open-label designed investigator-initiated clinical study (IIT) to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of WTX212A injection WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer

The trial consist of Screening Period (30 days), Treatment Period (21\*n days), Safety Follow-up Period (90 days) and Survival follow-up.

About 20 subjects are planned to be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* The subject signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures;
* Regardless of gender, aged 18 to 75 years old (including threshold);
* Histologically or cytologically confirmed locally advanced (stage IIB/IIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) with disease progression or intolerance after treatment or extensive stage small cell Lung cancer (SCLC)
* Patients with lung cancer who have been treated with at least 1 line system therapy or cannot currently receive standard therapy, and who have been treated with PD-1 or PD-L1 inhibitor antibody in the terminal line therapy regimen for ≥ 2 cycles;
* ECOG ≤1
* Expected life ≥ 3 months；
* Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration;

Exclusion Criteria:

* People with other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases,
* Patients with clinical symptoms and the need for repeated drainage of pleural and ascitic fluids;
* Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia;
* There have been adverse events related to the use of IO drugs that require permanent cessation of IO treatment;
* Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years. Exceptions include early tumors that have received radical treatment (carcinoma in situ or grade 1 tumor, non ulcerative primary melanoma with a depth of less than 1mm and no lymph nodes involved), skin basal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ that has received potential radical treatment;
* Subjects with symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment;
* Having hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases;
* Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment;
Study on the Efficacy of Infiltration of Upper Cluneal Nerves in Chronic Pain Related to Cluneal Syndrome

Lower back pain is a very common complaint in the Chronic Pain Clinic. Its etiology is nonspecific in 85% of the cases. In 1957, Strong and Davila reported that the superior cluneal nerves (SCNs) and middle cluneal nerves (MCNs) can be entrapped around the iliac crest, suggesting a causal relationship between this entrapment (SCN-Entrapment, SCN-E) and low back pain symptom. This is known today as "cluneal syndrome".

Cluneal syndrome remains poorly investigated and is currently a diagnostic challenge. Various types of lumbar movements exacerbate its occurence. The most common theory regarding the origin of this pain evokes that is primarily due to a mechanical cause linked to stenosis or adhesions of fibrous tissue around the cluneal nerves causing distress.

The hypothesis is that the investigator can reduce the pain related to the syndrome of superior cluneal origin thanks to a "volume effect" which aims to detach adhesions and/or aponeurotic stenoses that cause a distress of cluneal nerves.

The aim of this study is to assess the effectiveness of the cluneal nerve block using theThomas Dahl Nielsen ultrasound based technique in patients with chronic low-back pain related to SCN-E. To this end, the investigator will compare physiological serum injection versus local anaesthetic injection, with the aim of reducing short-term pain and improving quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Patient signed Inform Consent
2. Patient diagnosed with unilateral or bilateral superior cluneal syndrome :

Diagnostic points will be :

* a maximum pain at the trigger point on the back iliac crest, approximately 7 cm from the median line and 4.5 cm from the poster superior iliac crest. Palpation on this point causes pain reminding the patient's long-term pain),
* Palpation "rolled-palpated" at the buttocks provokes either pain, paraesthesia, or discomfort.
* The criteria of facial syndrome, sacro-iliac syndrome or radiculopathy are excluded.
* Low back pain during back movements.

Exclusion Criteria:

1. Pain not associated to superior cluneal syndrome.
2. Infection at the puncture point.
3. Pain of suspected neoplastic origin.
4. Allergy to local anaesthetics.
5. Refusal of the patient
Immediate Dental Implant Placed in the Presence of Chronic Inflammatory Periapical Lesions

Compromised teeth with periapical pathologies are removed before dental implant placement and sockets are left to heal.

Some clinicians began to immediately place dental implants in fresh extraction sockets associated with chronic inflammatory periapical lesions and these studies revealed high success rates

12 implants will be immediately placed in sockets associated with chronic periapical granuloma. Clinical (Wound healing, Pain, swelling, implant stability) and radiographic parameters (Peri-implant radiolucency) will be evaluated

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ranging from 18 to 45 years with no gender predilection agreed to come for minimum follow-up visits for 6 months.
* Adequate bone beyond teeth apices without jeopardizing any anatomical structure.
* Single rooted mandibular teeth with chronic inflammatory periapical lesions represented as periapical radiolucency, pulp necrosis, sinus tract, failed RCT.

Exclusion Criteria:

* Smokers and alcoholics.
* Medically compromised patients having uncontrolled diabetes or coagulation disorders.
* Restorable teeth.
* Periodontitis.
Pharmacokinetics and Metabolism Study in Healthy Male Participants

Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males


Eligibility Criteria:
Inclusion Criteria:

* Body weight 75-95kg, BMI 18.0-32.0 kg/m\^2
* Refrain from sperm donation 110 days after dosing

Exclusion Criteria:

* Current or recent gastrointestinal disease
* Any GI surgery that could impact drug absorption
* Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply
Evaluation Of Efficacy Of Liquid Platelet Rich Fibrin In Temporomandibular Joint Disorders

This randomized clinical trial aims to evaluate the efficacy of liquid platelet-rich fibrin administration at different Wilkes stages.

Thirty six patients with unilateral painful internal derangement (ID) (Wilkes' 3-4-5) were included. Patients were divided into 2 groups. In group 1 were treated with only artrosythesis. In group 2 were treated with artrosythesis and liquid platelet rich fibrin. In group 2, patients were injected with 1.5-2cc of liquid platelet-rich fibrin within the superior joint space at operation day. Pain and subjective dysfunction were recorded using a visual analog scale and Helkimo index at operation day and tenth day, one month later and 3 months later.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral internal temporomandibular disorder
* localized temporomandibular joint pain
* Scoring 3 and above in Wilke's classification.

Exclusion Criteria:

* Autoimmune diseases
* Significant mechanical obstruction that prevents mouth opening
* Acute capsulitis,
* Benign or malignant temporomandibular joint lesions
* Neurological disorders,
* Blood diseases and coagulation disorders
* Patients with a history of allergies or anaphylactic shock.
Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis

To evaluate the efficacy, safety, and tolerability of combination therapy with intramuscular interferon beta-1a and oral doxycycline, a potent inhibitor of matrix metalloproteinases, in patients with relapsing remitting multiple sclerosis (RRMS) having breakthrough disease activity.

Eligible individuals were evaluated monthly for 3 months while taking intramuscular interferon beta-1a, 30 micrograms weekly, then monthly for 4 months while receiving intramuscular interferon beta-1a, 30 micrograms and oral doxycycline, 100 mg daily.

Eligibility Criteria:
Inclusion Criteria:

* age 18-55
* Relapsing-Remitting Multiple Sclerosis (RRMS)
* Avonex therapy for 6 months prior continuous
* annualized relapse rate \>2 during Avonex therapy
* most recent relapse within 60 days of baseline
* entry Expanded Disability Status Scale (EDSS) 1.5-4.5
* one or more gadolinium (Gd+) MRI lesions on a baseline MRI
* no history of immune modulator or immunosuppressant therapy used in combination with Avonex (other then GSC administer for clinical relapses)
* not participating in any other study of ms therapeutics
* Serum neutralizing antibodies (NABs) titer to Avonex \<20

Exclusion Criteria:

* Medical or Psychiatric conditions that will affect patients ability to provide informed consent
* inability to undergo MRI
* clinically serious medical conditions or significantly abnormal labs
* no use of these medications or procedures within six months prior to study:

  \*monoclonal antibodies,total lymphoid radiation,systemic steroids,cytotoxic or immunosuppressive medications such as mitoxantrone or cyclophosphamide or any other investigational drugs
* Interferon neutralizing antibody titers \>20
* no breast feeding or pregnant
* no patients with any systemic illness,psychiatric condition or other disorder that would concern safety of patient to complete procedures of protocol
* abnormal blood test
* clinically significant abnormality on chest x-ray (CXR)
Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects

Primary Objective:

To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose

Secondary Objective:

To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug products after administration of a single SC dose

The duration of the study for each subject is 8-11 weeks broken down as follows:

* Screening: 2 to 21 days,
* Treatment: 1 day (2 overnight stays at the study site),
* Follow-up: up to 2 months after dosing.

Eligibility Criteria:
Inclusion criteria:

* Healthy male and female subjects between 18 and 45 years of age

Exclusion criteria:

* Presence or history of drug hypersensitivity or allergic disease
* History or presence of dermatological disorders
* Fever or persistent chronic or active recurring infection requiring treatment within 4 weeks prior to screening, or history of frequent recurrent infections
* Prior opportunistic infections within 6 months before inclusion
* History or presence of listeriosis or tuberculosis
* Any vaccination within 3 months (1 month for influenza vaccine) before inclusion
* Any biologics given within 4 months before inclusion
* Recent history of a parasitic infection or travel to a parasitic endemic area within 6 months prior to screening

The above information is not intended to contain all considerations relevant to a subject's potential participation in a clinical trial.
Effect of Intake of Hydrolyzed Krill Protein Isolate on Plasma Amino Acid Profile

Purpose: To examine the absorption of three different protein sources: hydrolyzed krill protein isolate, whey protein isolate, and soy protein isolate.

Design and Method: Randomized, controlled, double-blind cross-study, in which 12 healthy adult young men in randomized order ingest 35 g of protein of crude protein from one of the three protein sources or water on four different experimental days. Before and up to three hours after ingestion of the test beverage, blood samples are collected for 8 time points during each experimental day.

Eligibility Criteria:
Inclusion Criteria:

* men
* 18-30 years

Exclusion Criteria:

* smoking,
* medication,
* health issues conflicting with the experimental trial
Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma

The aim of this study is to investigate the change in iron metabolism in relation to malaria and helminth infections using a stable isotope technique.

The aim of the study is to determine how iron metabolism in subjects with infectious diseases (malaria, hookworm or S. haematobium) differs while infected and after treatment, i.e. the same individuals will be restudied while free of infection.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 12 to 16 years
* Body weight \> 30 kg
* no chronic medical illnesses
* no intake of vitamin/mineral supplements 2 weeks before the study and until the last blood drawing
* For each of the 4 arms the respective disease needs to be present (symptomatic malaria, asymptomatic malaria, hookworm infection, S. haematobium infection) without any other concurrent infection

Exclusion Criteria:

-
What is the Active Ingredient in Personalized Feedback Interventions for Problem Drinkers? A Randomized Controlled Trial

The major objective of this project is to conduct a randomized controlled trial comparing the impact of the normative feedback and other personalized feedback components of the Check Your Drinking (CYD) Internet-based intervention in the general population. Eligible problem drinking participants will be randomly assigned to one of four conditions in a 2 by 2 design - to receive just the normative feedback component of the CYD intervention, just the other personalized feedback information, to a no intervention control condition, or to receive the full CYD intervention. The no intervention control condition will not be sent any intervention materials but will instead be sent a list of the different components of the CYD feedback and will be asked to think about how useful they would find each of them. All participants will be followed-up at 3 months.


Eligibility Criteria:
Inclusion Criteria:

* problem drinkers as measured by an AUDIT score of 8 or more

Exclusion Criteria:

* none
Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fasting Condition

The purpose of this study is to determine the pharmacokinetics and bioequivalence of lamotrigine formulations after administration of single doses to non-smoking, healthy volunteers under fasted conditions.

A single-dose, two-way, bioequivalence study in up to 26 normal, non-smoking, healthy males and females will be utilized to evaluate the pharmacokinetics and bioequivalence of Lamotrigine chewable dispersible formulations under fasted conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females at least 18 years of age inclusive.
* Informed of the nature of the study and given written informed consent.
* Have a body weight within 15% of the appropriate range as defined in the
* 1983 Metropolitan Life Company tables and weighing at least 100 lbs. (Appendix I and II).

Exclusion Criteria:

* Hypersensitivity to Lamotrigine (Lamictal®), or similar compounds.
* Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
* Recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism.
* Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
* Received an investigational drug within the 4 weeks prior to study dosing.
* Currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
* Tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing.
* If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
Rajavithi Health Promotion Project (Population Base Cohort)

Metabolic Syndrome (hypertension, diabetes mellitus, obesity, cerebrovascular-cardiovascular disease) In Community Survey was performed in central Bangkok.

Prospective Cohort and intensive educated intervention (health promotion program in specific high risk groups) were performed. The aim of the study is to identify high risk patients who can develop serious complications from metabolic syndrome. An analysis of health outcomes in multiple dimensions will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Age 16 years or more
* Informed consent
* Living in selected community (Health Promotion area of Rajavithi Hospital)