cyrilzakka/clinical-trials huggingface dataset:
Regimen for the Treatment of Cachexia in Subjects With NSCLC

Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are not functioning and increased nutrition is not utilized.

To switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy must block multi-factorial stress signaling a threshold of activation. Consistent with the synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with advanced cancer demonstrating cachexia. This trial will evaluate the safety and efficacy of VT-122 in subjects with NSCLC who have hypercatabolic cachexia.

The objective of this trial is to evaluate the safety and dose tolerability of VT-122 regimen and to evaluate the efficacy of VT-122 regimen

This trial is to be conducted on patients who have a diagnosis of Stage IV NSCLC, are not on chemotherapy, have lost 5% of their body weight in the previous 2 months and are deemed to be hypercatabolic.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with NSCLC
* Demonstrating average weight loss of 5% within 2 months prior to enrollment
* Heart rate of 72 bpm or greater
* Negative pregnancy test (female patients of child bearing age)
* Able to give informed consent
* Able to be administered medication
* Able to take food and defined nutritional support
* Have not been on beta-blockers for a minimum of 1 week prior to administration of the medication screening dose
* Have not undergone surgery for at least 2 weeks prior to entry into trial
* Have not been on chemotherapy, immunotherapy, biologic therapy, radio therapy, and experimental therapy for a minimum of two weeks prior to medication screening dose and during their participation in this trial
* An expected survival for a minimum of 12 weeks

Exclusion Criteria:

* Contraindication to nonsteroidal antiinflammatory drugs (NSAIDs) and beta blockers
* Blood pressure less than 100/65
* Weight loss of 15% within 2 months prior to recruitment
* Hypersensitivity reaction to the active components in VT-122
* History of myocardial infraction within the past 3 months
* Congestive heart failure (as determined by symptoms and ECG)
* A-V block of second or third degree
* Unstable angina
* Uncontrolled diabetes
* Unable to be assessed for grip strength
* A positive pregnancy test
* Chronic infection or sepsis
* History of bleeding disorders
* Patients with peripheral edema
* Patients on digoxin or other chronotropic drugs
* Patients with evidence of severe dehydration
* Patients with evidence of ascites
Comparison of Facility and Home-based ART Delivery Systems in Uganda

The study is a 3-year, randomized trial to compare ART delivery through two different models: a) ART delivered through health facilities by clinically qualified staff and b) home-based care in which lay workers, i.e. non-medically qualified people, play a major role in the ART delivery and clients are followed up at health facilities less frequently. The primary objective is to measure the effects of these strategies on HIV viral load. We will also examine the effects on treatment failure, disease progression, survival, adherence, family member HIV testing, sexual behavior, and cost-effectiveness.

The study is a randomized trial to compare ART delivery through two different models: a) ART delivered through health facilities by clinically qualified staff and b) home-based care in which lay workers, i.e. non-medically qualified people, play a major role in the ART delivery and clients are followed up at health facilities less frequently. The primary objective is to measure the effects of these strategies on plasma HIV viral load. We will also examine the effects on treatment failure, disease progression, survival, adherence, family member HIV testing, sexual behavior, and cost-effectiveness.

The trial is conducted with The AIDS Support Organization (TASO) clinic in Jinja, Uganda. Randomization is conducted through geographic clusters, defined using sub-counties in the district, and stratified by distance from fixed health facilities, and urban/rural. Just over 800 participants, living in 40 clusters, will be recruited over a period of 3-6 months and followed-up over a period of 3 years.

Eligibility Criteria:
Inclusion Criteria:

HIV infection Plan to remain resident in the area for at least 12 months CD4 cell count \<200 cells/mm3 or severe symptomatic HIV (WHO stage 3 or 4) Identify a medicine companion who will assist in adherence to ART treatment Age 18 years or above.

Exclusion Criteria:

Abnormal liver and renal function test results (AST or ALT ≥ 5x upper limit of normal Calculated creatinine clearance \< 25 ml/min). The tests are conducted only in individuals in whom they are clinically indicated
Safety and Effectiveness of Extended Circumferential Decompression for Thoracic Ossification of Posterior Longitudinal Ligament

The study was to evaluate the indications, efficiency and safety of the extended posterior circumferential decompression technique for the treatment of thoracic ossification of posterior longitudinal ligament (TOPLL) with dura adhesions or ossification.

The clinical characteristics of patients with TOPLL combined with dura adhesions who underwent extended circumferential decompression in our hospital were retrospectively investigated. TOPLL adhered with dura matter or dura ossification were detected intraoperatively in all the cases. Imaging evaluation included the ossification-kyphosis angle and the fixed-segment kyphosis angle. A modified Japanese Orthopedic Association Score (JOA score) was applied for the evaluation of clinical outcomes.

Eligibility Criteria:
Inclusion Criteria: (1) thoracic myelopathy caused by TOPLL with or without TOLF; (2) severe adhesions between dura mater and ossified lesion with or without dura ossification confirmed intraoperatively; (3) extended posterior circumferential decompression was applied; (4) pedicle screw instrumentations were implanted after decompression; (5) follow-up for more than 6 months; (7) complete clinical data.

Exclusion Criteria:

(1) spinal deformities; (2) thoracic spine fractures; (3) syringomyelia, spinal tumor, myelitis, etc.; (4) coexisted with cervical spondylosis and lumbar stenosis; (5) post operation of thoracic spinal stenosis; (6) recurrent myelopathy caused by lesions in other levels than the decompressed segments.
The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma

This is a behavioral randomized controlled trial of adults with uncontrolled persistent asthma that tests if the Propeller Health sensor, mobile application, and dashboard can improve adherence to ICS.


Eligibility Criteria:
Inclusion Criteria:

* Under the care of a staff asthma physician (i.e. pulmonologist or allergist/immunologist) at NorthShore University HealthSystem (NS)
* Have an active NorthShore Connect (patient portal) account
* Persistent uncontrolled asthma in the past 12 months
* Active prescription for daily ICS medication for asthma

Exclusion Criteria:

* candidate refusal
* the presence of other co-morbidities (e.g. severe psychiatric disorder) that could interfere with study participation
Analgesia Management in Bariatric Surgery

Following laparoscopic bariatric surgery, multimodal analgesia is recommended to avoid the adverse effects of opioids by reducing their use. Although lidocaine, ketamine, and dexmedetomidine have been used as adjuvant analgesics, no studies have evaluated the superiority of their intra- and postoperative infusions as components of multimodal analgesia in bariatric surgery. The present study is aimed to compare lidocaine, dexmedetomidine, and ketamine in multimodal analgesia management following Sleeve Gastrectomy Surgery. Postoperative pain scores, the requirement for additional postoperative analgesia, retching, nausea and vomiting, time to mobilization, and hospital length of stay will be evaluated.

Patients will be divided into three groups.

Group L: The patients will receive intravenous lidocaine (2 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 1 mg/kg/h. The infusion will continue until 12 hours after the operation.

Group K: The patients will receive intravenous ketamine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation.

Group D: The patients will receive intravenous dexmedetomidine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation.

Ketamine, lidocaine, and dexmedetomidine doses will be calculated according to ideal body weight, lean body weight, and actual body weight, respectively.

Randomization will be performed using a computer-generated random number list, and a statement indicating the patient's group will be placed in a closed envelope numbered according to the result. Each patient will be asked to choose an envelope, and the patients will be assigned to the study according to the group mentioned in the envelope.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index\>35 kg/m2
* The American Society of Anaesthesiologists (ASA) physical status class II III
* Patients who will undergo an elective laparoscopic sleeve gastrectomy (LSG)

Exclusion Criteria:

* refusal to participate
* allergy to the study drugs
* chronic kidney disease (creatinine\>150 μmol/L)
* mental illness
* liver, respiratory or oncological disease,
* cardiac dysfunction (ejection fraction \<40%),
* uncontrolled hypertension,
* preoperative analgesic use,
* chronic pain,
* history of alcohol or drug addiction
Long-term Surival of GIST Patients ≥ 10 Years on Imatinib

This is a cross-sectional cohort study of metastatic GastroIntestinal Stromal Tumor (GIST) patients on imatinib for ≥ 10 years included in EORTC trial 62005-STBSG entitled "Phase 3 randomized, intergroup, international tiral assessing the clinical activity of STI-571 at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) expressing the KIT receptor tyrosine kinase (CD117) - NCT00685828". With this study, the aim is to identify patient characteristics, tumour characteristics, treatment factors and quality of life outcomes associated with prolonged treatment with imatinib and/or prolonged survival. This observational study will further help to put in place a questionnaire to evaluate patients quality of life with prolonged imatinib treatment, that will then be used in a prospective study.


Eligibility Criteria:
Inclusion Criteria:

* Patients included in the EORTC 62005 trial: Adult patients with metastasized GIST
* Patients who have been treated with imatinib for ten years or longer
* For the identified patients who are still alive:

  1. Able to read and answer questionnaires
  2. Able to provide written informed consent
Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy

For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of \<50% as the criterion of treatment change. Sixty patients will be enrolled to randomize into two groups：receiving modified chemotherapy and receiving the original chemotherapy.

For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of \<50% as the criterion of treatment change. Sixty patients will be enrolled to randomize into two groups：receiving modified chemotherapy and receiving the original chemotherapy. Overall survival and disease-free survival will be observed between two groups.

Eligibility Criteria:
Inclusion Criteria:

* TNM stage of T2-T4 or positive regional lymph nodes, according to the American Joint Committee on Cancer (AJCC) 7.0 staging system, verified by enhanced abdominal computed tomography (CT) and/or endoscopic ultrasound (EUS), positron emission tomography (PET)/CT scan), with no evidence of distant metastases;
* ECOG performance status score ≤2 without serious heart, lung, liver, kidney, or hematological dysfunctions;
* age ≥18 years old;
* no previous chemotherapy, radiotherapy, or surgical treatment for gastric cancer;
* gastrectomy was performed after preoperative chemotherapy if imaging studies did not confirm disease progression (according to the Response Evaluation Criteria in Solid Tumors (RECIST)) ;
* signed the informed consent form.

Exclusion Criteria:

* All do not reach the inclusion criteria
Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

This is a parallel, Phase 2, 2-arm, double-blind, randomized, multicenter, multinational, placebo-controlled study to evaluate efficacy, safety, pharmacokinetics (PK), and biological effects of treatment of subcutaneous injection of amlitelimab compared with placebo in male and female participants aged 18 to 70 years with moderate to severe hidradenitis suppurativa (HS).

The purpose of this study is to measure standardized clinician reported and participant-reported outcomes (ClinRO and PRO), safety, and drug concentration. An optional long-term extension (LTE) period will assess chronic safety and efficacy over an additional 80 weeks of amlitelimab treatment.

Study details include:

* The study duration will be up to 116 weeks, including a 4-week Screening period, a 16-week double-blind treatment period (DBT), an optional 80-week LTE period and a 16-week post-treatment follow-up period.
* All participants who complete the 16-week DBT period will be offered entry into an optional LTE.
* Participants who do not wish to enter the optional LTE period or who stop treatment prior to Week 16 (Visit 6) or stop investigational medicinal product (IMP) administration prior to completing the LTE period will proceed into the 16-week post-treatment follow-up period.
* The number of planned in clinic visits will be up to six during the DBT period with an additional nine during the LTE period, plus one post-treatment follow-up end-of-study visit. Up to 11 optional in clinic visits are allowed for participants who do not wish to self-administer IMP between scheduled in clinic visits during the LTE period.

The study duration per participant will be up to 116 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be 18 (or country's age of majority if \>18) years to 70 years of age inclusive, at the time of signing the informed consent.
* Participants with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
* Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), 1 of which must be Hurley Stage II or Hurley Stage III.
* Participant must have had an inadequate response to at least a 12-week trial of an oral antibiotic for treatment of HS

Exclusion Criteria:

* Participants with a diagnosis of inflammatory conditions other than HS (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc)
* Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patient has ocular hypertension or glaucoma in both eyes
* Requires IOP-lowering therapy in each eye

Exclusion Criteria:

* Active or recurrent eye disease that would interfere with interpretation of study data in either eye
* History of any eye surgery or laser in either eye within 6 months
* Required chronic use of other eye medications during the study
* Anticipated wearing of contact lenses during the study.
* Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
Tolerance of Anti-Cancer Therapy in the Elderly

This is a multicentre observational study evaluating frailty and tolerance of chemotherapy in the elderly.

This is a multicentre observational study evaluating frailty and tolerance of chemotherapy in the elderly.

The number of people with cancer over the age of 65 years is increasing and more older patients are being treated with chemotherapy. Previous research has shown that patients living with frailty are more likely to experience significant toxicity from chemotherapy.

A scoring system exists, the CARG (Cancer Aging Research Group) score), which using sociodemographics, tumour/treatment variables, laboratory test results (haemoglobin and creatinine clearance), geriatric assessment variables (function, co-morbidity, cognition, psychological state, social activity/support and nutritional status) predicts the likelihood of patients in this population developing a grade 3-5 toxicity. The CARG score ranges from 0 (lowest toxicity risk) to 19 (highest toxicity risk).

This scoring system was developed and validated in the USA (United States of America). It was not however found to be predictive of toxicity in Australia. To date it has not been evaluated, nor is used in routine practice in oncology in the UK (United Kingdom).

This study is looking at markers of frailty in patients \>65years. The investigators seek to predict those who are at a higher risk of side effects from chemotherapy. The investigators are looking to validate the CARG score in a UK NHS (National Health Service) population and show feasibility of using this in routine practice. The investigators are also evaluating if other scoring systems which are routinely used to assess frailty (but have never been assessed for predicting toxicity) are useful in predicting toxicity.

Secondary objectives include describing frailty in this population, exploring patients' perceptions of risk associated with chemotherapy and demonstrating the added value of risk prediction tools compared to clinicians estimates of toxicity risk.

Eligibility Criteria:
Inclusion Criteria:

* Age \>65years
* About to start first line chemotherapy for a solid tumour based malignancy
* Chemotherapy given for any intent eg. adjuvant or palliative
* Estimated survival of \>3months
* Able to comprehend and complete questionnaire.

Exclusion Criteria:

* Medical or psychiatric condition impairing ability to consent
* Participant is enrolled in another clinical trial
* Prior chemotherapy for any indication
* Receiving concurrent radiotherapy (RT) or immunotherapy (IT)
* Unable to provide informed consent
Effect of Tactile-Kinesthetic Stimulation on Preterm Neonates

An interventional study to evaluate the effect of tactile-kinesthetic stimulation (TKS) on growth, neurobehavior and development among preterm neonates in the neonatal unit of Dr. Cipto Mangunkusumo Hospital.

Preterm neonates were recruited via random sampling and divided into two groups (intervention group and control group). A written informed consent was obtained from the parents or guardians.

Before the intervention, physical examination was performed to ensure the neonates had normal vital signs, were healthy and did not present with congenital abnormalities.

In the intervention group, TKS was performed with specific baby oil for 15 minutes, three times a day, for 10 days. After 10 days, TKS was applied once daily by the mother or caregiver. TKS implementation at home was supervised by the investigator or nurse through phone call. The TKS were documented by the mother or caregiver in the diary card, which should be brought during the next visit when the neonate was 11-14 days old. In addition to TKS, history of illness and nutrition which was confirmed through history taking during hospital or home visit, was also recorded. The participants who did not go the hospital were home visited by the investigator or nurse.

Anthropometric measurement by investigator and trained nurses and Dubowitz examination was performed by investigator in a warm and quiet place in the neonatal unit, mother-baby unit, outpatient clinic or participants' home while the neonate was fully alert.

At 3 months of age, infant development was assessed by the investigator using the Capute scales (Developmental Quotient of Clinical Adaptive Test \[DQ CAT\], Clinical Linguistic Adaptive Milestone Scale \[DQ CLAMS\]) and the Full Scale Developmental Quotient (FS DQ) score. The Clinical Linguistic Adaptive Milestone Scale (CLAMS) score was based on the parent's report of language skill attainment. The Clinical Adaptive Test (CAT) score was based on the child's performance according to the listed items.

Eligibility Criteria:
Inclusion Criteria:

* 6-24-hour-old preterm infants with 32-\<37 gestational weeks
* birth weight ranging from 1,500 to \<2,500 g
* appropriate for gestational age
* a minimum Apgar score of seven at the fifth minute
* no history of neonatal resuscitation
* stable vital condition
* no invasive therapy during hospitalisation

Exclusion Criteria:

* intrauterine growth retardation
* untreated clinical sepsis
* congenital abnormalities such as congenital heart disease
* history of hyperbilirubinemia
Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy

This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase inhibitor in patients with diabetic sensorimotor polyneuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the following may enter:

Clinical signs and symptoms (footpain, numbness, tingling, weakness, etc.) of symmetrical distal Diabetic Sensorimotor Polyneuropathy with diagnosis by Nerve Conduction Tests and/or Quantitative Sensory Test.

* 18 to 70 years old of either sex and any race
* Type I or Type II, insulin-dependent or non insulin-dependent diabetes for at least six months prior to study entry
* Healthy in general
* No hospitalizations for diabetic control or episodes of ketoacidosis for three months prior to screening
* Female patients of childbearing potential must have a negative serum pregnancy test

Exclusion Criteria:

* Known non-diabetic causes of neuropathic symptoms
* Diabetic patients with no neuropathy or severe neuropathy
* Used any Aldose Reductase Inhibitors within one year of screening
* Clinically significant illness including unstable cardiac, pulmonary, hematologic, hepatic, renal, or neoplastic disease
* A history of systemic carcinoma within five years of screening
* A history of epilepsy or serious head injury
* A history or evidence of drug or alcohol abuse
* Test positive at screening for hepatitis B surface antigen or hepatitis C antibody or have a history of a positive result, or patients with evidence of significant hepatic insufficiency
* A history of known or suspected diagnosis of AIDS, or have tested seropositive for HIV antibody or antigen previously