cyrilzakka/clinical-trials huggingface dataset:
A Study ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas

This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas.

This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas. Dose Escalation Phase: Approximately 40-50 subjects with a maximum number of 62; Dose Expansion Phase: Estimated 100-400 subjects depending on the number of cohorts to be expanded.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
2. Aged at least 18 years as of the date of consent.
3. Histological or cytological confirmation of a solid tumor, and has progressed despite standard therapy, or is intolerant to standard therapy, or has a tumor for which no standard therapy exists or for which standard therapy is not considered adequate. Estimated life expectancy of a minimum of 12 weeks.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
5. Female and male subjects should be using adequate contraceptive measures as requested.

Exclusion Criteria:

1. Subjects with CNS tumors or known CNS metastases will be excluded.
2. Prior ATG-101 administration or a 4-1BB agonist.
3. Prior anti-tumor systemic therapy within 21 days(a period of 5 'half- lives') of the first dose of study treatment.
4. Radiotherapy with a wide field of radiation within 28 days.
5. With the exception of alopecia, any unresolved toxicities from prior therapy greater than Grade 1 (CTCAE v5.0) at the time of ICF signature.
6. Active infection, including hepatitis B and/or hepatitis C.
7. Have uncontrolled intercurrent illness, including but not limited to:
8. Inadequate bone marrow reserve or organ function.
9. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101.
10. Prior organ allograft transplantations.
11. Pregnant or nursing females.
12. Have a history of another primary malignancy within 3 years prior to starting study treatment. Exceptions are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ, etc.
13. In the opinion of the investigator, subject's complications or other conditions may affect protocol compliance or may be unsuitable for participation in the study.
Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer

The investigators primary aim is to increase chemotherapeutic drug uptake in inoperable tumours

The specific sub-objectives of the studies are:

* To quantify tumour sizes and relate it to the patient survival over time, dependent of treatment method.
* To evaluate and compare the toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
* Develop and validate new ultrasound perfusion algorithms based on burst- replenishment for diagnosis and monitoring of therapy.
* To quantify gemcitabine and its main metabolites in plasma and in circulating mononuclear cells before, during and after pancreatic sonication, and to quantify the concentration of intracellular endogenous nucleotides in circulating mononuclear cells at the same time points.
* To assess plasma and tissue concentrations of gemcitabine, its main metabolites and endogenous nucleotides in those patients where surgical resection can be performed on standard clinical indications.

The primary outcome is monitor for toxicity effect for the combination therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with inoperable pancreatic cancer (ICD-10 C25.0-3) at the Department of Surgical Gastroenterology of Haukeland University Hospital, who have volunteered to participate

Exclusion Criteria:

* Patient participated in an investigational study within 30 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug).
* Patient has severe chronic obstructive pulmonary disease or severe chronic asthma.
* Patient has a history of cardiovascular ischemia, acute myocardial infarction or unstable angina within 3 months prior to study entry.
* Patient has a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
* Patient has a known history of Hepatitis B, Hepatitis C or HIV infection.
* Patient requires dialysis or has severely impaired renal function, defined as a serum creatinine \> 180 mmol/L at the Screening Visit.
* Patient has severe impairment of liver function, defined as a serum albumin level ≤ 25 g/L and/or a Protrombin Time INR \> 2.3 (or APTT \> 6 seconds above the upper limit of normal) at the Screening Visit.
* Patient is pregnant or is breast-feeding.
* Patient is allergic to or intolerant of gemcitabine
* Patient is allergic to or intolerant of SonoVue® BRACCO ultrasound contrast agent
* Any reason why, in the opinion of the investigator, the patient should not participate.
Bobath Approach for Trunk Control in Acute Stroke Patients

In stroke patients, the impairment of the trunk affects many functions negatively. For this reason training of the trunk is necessary in the early period. Taking into account of literature, various approaches have been used to improve sitting balance and trunk control such as conventional physiotherapy for stroke patients . Bobath concept is another method used for stroke rehabilitation. When the studies about stroke rehabilitation are investigated, it is seen that most of the studies included only chronic patients and Bobath concept did not adequately take place in literature about trunk training. The aim of this study is to determinate effectiveness of the Bobath based trunk training on trunk control in acute stroke patients.

In stroke patients, the impairment of the trunk affects many functions negatively. For this reason training of the trunk is necessary in the early period. Taking into account of literature, various approaches have been used to improve sitting balance and trunk control such as conventional physiotherapy for stroke patients . Bobath concept is another method used for stroke rehabilitation. Trunk control is an important issue in the Bobath approach since the acute period. It seems that the Bobath method, which includes both approaches to increase postural control and sitting, as well as applications to increase the sensation, seems to be an appropriate method to improve body control in stroke patients. When the studies about stroke rehabilitation are investigated, it is seen that most of the studies included only chronic patients and Bobath concept did not adequately take place in literature about trunk training in acute stroke. The aim of this study is to determinate effectiveness of the Bobath based trunk training on trunk control in acute stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* patients scoring ≥14 on Glasgow Coma Scale and Mini Mental Test\>24

Exclusion Criteria:

* patients scoring \<14 on Glasgow Coma Scale
* patients with recurrent strokes
* patients with orthopedic or neurological disorders (other than strokes) that might affect their motor performance
Study of Modified Constraint-Induced Aphasia Therapy Schedule to Treat Patients Following Sub-acute Stroke

The purpose of this study is to assess the feasibility of modified Constraint-Induced Aphasia Therapy (CIAT) in the early sub-acute stage and to examine the efficacy of modified CIAT versus standard treatment with the same intensity of intervention.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of first-ever stroke
* aphasia in sub-acute stage
* german speakers

Exclusion Criteria:

* presence of residual aphasia
* dysarthria and apraxia of speech
The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a Chinese herb formula.

1) Liver fat (measured by CT scan) and liver function assessed by liver enzymes levels; 2) Insulin sensitivity measured by HOMA index, oral glucose tolerance test (OGTT) and a euglycaemic hyperinsulinaemic clamp (with stable isotopes) in a subset of the subjects; 3) Plasma lipid profile and non esterified fatty acids (NEFA) concentration; 4) Circulating levels of adipokines.

Eligibility Criteria:
Inclusion Criteria:

* subjects with NAFLD(nonalcoholic fatty liver disease) (criteria of Society of Hepatology, Chinese Medical Association, 2002.10),
* aged 18-65
* alcohol consumption less than 40g/week;
* liver/spleen (L/S) ratio no more than 1 by CT scan.

Exclusion Criteria:

* ALT more than twice the upper end of the normal range
* viral hepatitis
* total parenteral alimentation or secondary liver disease such as hepatocirrhosis, autoimmune hepatitis, metabolic liver disease or drug induced liver disease
* severe cardiovascular or renal dysfunction
* Subjects with diabetes (fasting glucose more than or equal to 7.0mmol/L or postprandial glucose more than or equal to 11.1mmol/L)
* Subjects treated with statins
Computerized Questionnaires in Assessing Symptoms, Pain, Depression, and Physical Function in Patients With Metastatic and/or Advanced Locoregional Cancer

RATIONALE: A computer-based system for assessing symptoms may be effective for patients with metastatic or advanced cancer.

PURPOSE: This clinical trial is studying how well computerized questionnaires work in assessing symptoms, pain, depression, and physical function in patients with metastatic and/or advanced local/regional cancer.

OBJECTIVES:

* Determine the feasibility of applying a computer-based system for symptom assessment and classification in palliative cancer care in patients with metastatic and/or advanced cancer.
* Examine hypothesized differences across groups related to acceptance of computers (i.e., age, culture, stage of disease, cognitive and physical function, etc.).
* Examine the general user-friendliness of the tool.
* Test and validate the performance of selected domains and items for classification and assessment of pain and cachexia.
* Explore the validity of domains and items for depression.

OUTLINE: This is a multicenter study.

All patients undergo computer-based assessments of general symptoms by the Edmonton Symptom Assessment System (ESAS) and the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ C30) questionnaires and assessment of physical function, appetite/weight loss, and depression by the Brief Patient Health Questionnaire 9 (PRIME-MD PHQ9). Patients who score ≥ 1 (on a 0-10 numerical rating score) on the pain screening question with or without occurrence of breakthrough pain (BTP), undergo the Alberta BTP Assessment tool assessing precipitating factors for pain, time to pain relief after intake of medication, and satisfaction with medication. Patients complete questions regarding user-friendliness and feasibility of using the computer at the end of their session.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of incurable cancer, including patients receiving life-prolonging treatment
* Metastatic and/or advanced locoregional disease

PATIENT CHARACTERISTICS:

* Able to provide written informed consent
* Fluent in the language used at the study site

PRIOR CONCURRENT THERAPY:

* No prior inclusion in this study
Calcium Dobesilate for Chronic Venous Wounds

The objective of the study is to assess the efficacy of calcium dobesilate for treating chronic venous wounds.

The hypothesis is that venous ulcers treated with standards measures (compressive measures) and calcium dobesilate will heal-up better than venous ulcers treated with standards measures (compressive measures) and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients with venous ulcer (CEAP 6) that affect epidermis, dermis and/or subcutaneous tissue, with and area superior to 3 cm2
* Ankle-arm index 0.9 or superior
* Written informed consent of the patients

Exclusion Criteria:

* Patients with venous ulcer (CEAP 6) that affect bone or with and area inferior to 3 cm2
* Ankle-arm index inferior to 0.9
* No written informed consent of the patients
* Diabetes mellitus I y II
* Patients with renal failure and dialysis
* Vascular surgery needed
* Impossibility to use compressive measures on the leg
* Use of topic antibiotics, silver dressing, growth factors, plasma-rich in platelets, skin graft, pentoxifylline, ultrasounds, laser, hyperbaric oxygen, electric stimulation o vacuum.
* Pregnancy
* Breast feeding
* No anticonceptives measures
* Allergy or intolerance to phebotonics
* Background of neutropenia or leucopenia
* Basal leucocytes \< 3.500/ml
Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation

We aim at comparing markers of HIV reservoir, monocyte function and immune activation between antiretroviral therapy (ART)-naïve (chronic infection or primary infection), ART-controlled or ART-failing HIV infected adults initiating a dolutegravir (DTG)-based regimen. The investigators' purpose is to measure cell associated HIV-1 DNA, monocyte function \[soluble CD14 (sCD14), soluble CD163 (sCD163)\], and immune activation \[neopterine, interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP)\] biomarkers at different time points between baseline and week 48 post DTG-based regimen initiation in each group.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged from de 18 to 80 years
* Patient starting a DTG-regimen
* Patients agreeing to use methods of birthcontrol while on the study and during the 6 weeks after stopping DTG treatment
* Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* HBV or HCV coinfection
* Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted
* Documented resistance to DTG
* Allergy or intolerance to the study drugs or their components or drugs of their class
* Any acute or verified Grade 4 laboratory abnormality (with the exception of Grade 4 lipids) at Screening.
* Coadministration with Dofelitide
Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) - Based Planning and Creation of Orthodontic Appliances

In orthodontics, conventional fixed appliances, usually consisting of prefabricated components, require step-by-step adjustment in order to move teeth in the planned direction.

May treatment be improved with customized archwires?

Study hypotheses:

* By using CAD/CAM in planning and fabrication of customized archwires, unnecessary tooth movements can be avoided and teeth can be moved on their direct path to the intended position.
* The application of CAD/CAM improves reproducibility, efficiency, and quality of orthodontic treatment.

In orthodontics, conventional fixed appliances, usually consisting of prefabricated components, require step-by-step adjustment in order to move teeth in the planned direction. At the moment there is no tool, that allows to predict the treatment result. Using conventional orthodontic treatment methods the orthodontist approaches the final result using the trial-and-error-method, bending the wires in each appointment until both, patient and orthodontist are satisfied. Usually there is only a general treatment plan, but not a detailed treatment plan of each tooth movement. This leads to a longer treatment time and causes more costs. Besides the probability of side effects (such as caries root resorption) increases with the duration of the treatment.

In this case the chosen technology is called SureSmile(R)(by OraMetrix). SureSmile allows the collection 3D-data intraorally and from plaster models, it gives a possibility of computer aided treatment planing (Computer Aided Design) and the manufacturing of customized archwires (Computer Aided Manufacturing).

This new technology promises to reduce the time and effort of an orthodontic treatment providing predictability and quality also minimizing negative side effects.

This technology could - using this diagnostic 3D-system - help to understand orthodontic movement and basic principles of the remodeling of the periodontium and to improve orthodontic mechanics.

Eligibility Criteria:
Inclusion Criteria:

* treatment with fixed orthodontic appliances is indicated
* complete secondary dentition
* age: 11-30
* in good general health
* patient is informed about study and agrees to participate

Exclusion Criteria:

* syndromes affecting bones and teeth
* cleft lip and palate
* inflammation or reduction (more than 50%) of periodontium
* intake of drugs affecting tooth movement and bone formation
* disturbance of bone formation
* disturbance of thyroidal function
* pregnancy
* participation in additional study affecting oral hygiene
* former therapy with ionized radiation or cytostatic drugs
* caries (active phase)
* alcohol dependency
A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)

This study was conducted to assess the safety and tolerability of the drug and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee
* Either prior NSAID or Acetaminophen users within the the ARA functional class I,II or III
* Patients required to demonstrate a "flare" of the signs and symptoms of OA following withdrawal of NSAID treatment
* Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA.

Exclusion Criteria:

* No history of concurrent arthritic disease
* uncontrolled hypertension or an active cardiac condition
* No history of hepatitis, neoplastic disease, stroke or transient ischemic attack within a specified duration.
Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Endometriosis is a common cause of pelvic pain in women which has been historically under-studied and under-diagnosed. The goal of this research is to pilot-test the feasibility and acceptability of a manualized, single-session brief mindfulness-based intervention (BMBI) among participants with endometriosis-related chronic pelvic pain (ECPP) who undergo surgical treatment, and gather preliminary data necessary for future studies assessing BMBI's impact on outcomes in surgically-treated ECPP. This pilot study will enroll 10-20 adult participants with ECPP to receive either a BMBI adjunctive to treatment as usual (TAU; n=5-10) or education with TAU (n=5-10) prior to their ECPP surgery. The central hypothesis is the BMBI is feasible to deliver pre-operatively, acceptable to patients, and may help improve acute post-surgical outcomes through more adaptive stress coping and pain processing, enabled by mindfulness training.


Eligibility Criteria:
Inclusion Criteria:

1. age 18 years or older
2. diagnosis or probable diagnosis of endometriosis
3. candidate for surgical procedure for endometriosis
4. English speaking
5. have access to wifi and email

Exclusion Criteria:

1. prior formal mindfulness training
2. Unable to consent
THE EFFECT OF VITAMIN C ON POST-ORTHODONTIC TREATMENT RELAPSE

The aim of this study is to evaluate and compare the effect of locally injected and orally administered (systemic) Vitamin C on post-orthodontic treatment relapse


Eligibility Criteria:
Inclusion Criteria:

* Patients who were indicated for non-extraction orthodontic treatment.
* Adult patients with finished orthodontic treatment, using fixed appliance therapy.
* Patients with good oral hygiene, and a healthy periodontal condition.

Exclusion Criteria:

* Patients who received sectional fixed appliance therapy.
* Patients with hypodontia requiring tooth replacement in the retainer, as a temporary measure.
* Patients requiring fixed bonded retainers.
* Pregnant and lactating women.
* Patients with hereditary hemochromatosis.
* Cancer patients, receiving chemotherapy.
* Patients with chronic diseases such as diabetes, or those receiving drugs such as corticosteroids, both of which that may affect tooth movement.
Efficacy of the DOMINO Diet App in IBS

The aim of this study is to evaluate whether the DOMINO diet application is an effective tool in the treatment of Irritable bowel syndrome in tertiary care. Furthermore, this study aims to determine the response rate of the strict low FODMAP diet in non-responders to the DOMINO diet.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
3. Patients with irritable bowel syndrome according to Rome IV diagnostic criteria
4. Patients ages between 18 and 70 years old

Exclusion Criteria:

1. Participant has a history of any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years
2. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
4. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
6. Patients presenting with predominant symptoms of functional dyspepsia (FD) and of gastro-oesophageal reflux disease (GERD)
7. Patients following a diet interfering with the study diet in opinion of the investigator
8. Patients who already followed the low FODMAP diet under guidance of a trained dietitian without success