cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals

To investigate the safety of polyethylene glycolated interleukin-2 (PEG IL-2) given subcutaneously in conjunction with antiviral treatment and to explore the effects of treatment on surrogate markers of efficacy and incidence of opportunistic infection and other clinical markers of HIV disease.

Four escalating doses of PEG IL-2 are studied. Patients are stratified by CD4 level. CD4 levels in Group A are 200 to 500 cells/mm3; in Group B - 1 to less than 200 cells/mm3. Further stratification is by p24 positive or negative, antiviral therapy for more or less than a year, and zidovudine (AZT) versus didanosine (ddI). The duration of PEG IL-2 treatment is a maximum of 28 weeks. This is an outpatient study; patients will be observed for four hours after the first dose of PEG IL-2 and for one hour after subsequent doses.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV seropositivity by commercially available ELISA.
* Meet Disease Status criteria.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Concurrent neoplasms other than basal cell carcinoma of the skin, in-situ carcinoma of the cervix or limited cutaneous Kaposi's sarcoma.
* Recently treated HIV-related lymphoma.
* Major organ allograft.
* Presence of space occupying central nervous system (CNS) lesions or other conditions which would be anticipated to cause cerebral edema.
* Renal compromise or use of drug therapy anticipated to lead to renal compromise.
* Active opportunistic infection requiring hospitalization or exclude medication.
* Requiring continual acyclovir for suppression of herpes infection.

Concurrent Medication:

Excluded:

* Acyclovir.
* Drug therapy anticipated to lead to renal compromise.

Patients with the following are excluded:

* Intolerance to zidovudine (AZT) at 300 mg/day divided q8h or didanosine (ddI) at 7 mg/kg/day given twice a day.
* History of HIV-related lymphoma.
* History of asthma requiring frequent therapy, chronic pulmonary disease, hypertension requiring therapy, or congestive heart failure.
* Any of the symptoms or conditions listed in Exclusion - Co-Existing Conditions.

Prior Medication:

Excluded:

- Any prior therapy with interleukin-2 (IL-2) or PEG IL-2.

Excluded 30 days prior to study entry:

- Treatment with other anti-HIV medication or known immunomodulators or other chemotherapy or radiation therapy.

Active substance abuse so patients would be anticipated to be poorly compliant with protocol requirements.
The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma

Outpatient department of cmch, ceitc,cimch POAG patients enrolled for the study.


Eligibility Criteria:
Inclusion Criteria:

* IOP 22_34mmof Hg,newly diagnosed case, bilateral POAG patients Patients.

Exclusion Criteria:

* pregnant and lactating women, infection, any eye surgery.
Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk

The goal of this clinical trial is to examine the feasibility, utility, and efficacy of a smartphone-based assessment battery and remotely administered virtual Neuromuscular/Dual-Task (vNDT) intervention among healthy U.S. military service members and physically active young adults with a recent concussion.

Aim 1. Determine the baseline neuromuscular/dual-task performance characteristics among a sample of active-duty military service members compared to physically active young adult civilians.

The investigators hypothesize that active-duty military service members will have similar baseline gait and dual-task abilities as civilians, demonstrating translation potential between populations.

The investigators also hypothesize that baseline gait and dual-task abilities will be influenced by history of prior mTBI injuries among military Service Members.

Aim 2. Examine the efficacy of a smartphone-based vNDTT intervention to reduce musculoskeletal injury and improve neuromuscular/dual-task performance after a recent mTBI.

The investigators hypothesize that those randomized to the intervention within three weeks of mTBI will have a lower risk of MSK injury in the 3-month period following mTBI, relative to standard-of-care.

The investigators also hypothesize that those randomized to the intervention within three weeks of mTBI will have better post-intervention gait and dual-task performance than those assigned to standard-of-care, despite similar baseline performance.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years of age at the time of enrollment
* Mild TBI or concussion diagnosis by a physician
* Confirmed MTBI diagnosis via VA/DOD guidelines at time of enrollment
* Participation in regular physical activity prior to injury (confirmed via the Global Physical Activity Questionnaire \[GPAQ\]) (Cleland et al., 2014; Keating et al., 2019)
* Access to a smartphone for app download

Exclusion Criteria:

* Moderate or severe TBI
* Pre-injury neurological disorder
* Abnormal brain imaging findings (if performed as a part of routine care)
* Previous TBI (mild/moderate/severe) \<12 months prior to enrollment other than the current injury for which they are being seen
Collaborative Adolescent Research on Emotions and Suicide

Suicide is the third leading cause of death among adolescents in the US yet there is a paucity of research on effective treatments for this population. The primary aim of the research described in this application is to evaluate the efficacy of dialectical behavior therapy (DBT) for suicidal adolescents. DBT has an empirical track record with suicidal adults of reducing the incidence, frequency and medical risk of suicide attempts and non-suicidal self-injuries among individuals meeting criteria for borderline personality disorder (BPD). While DBT is widely used in the community with suicidal adolescents, particularly those with difficulties characteristic of BPD such as poor emotion regulation and impulse control, no randomized trial of DBT with suicidal adolescents has ever been conducted. And, while non-randomized trials indicate that the intervention is both safe and effective, without a randomized trial the investigators simply do not know whether DBT for suicidal adolescents is efficacious or not. Given the severity of the problem and the lack of alternative treatments for high risk adolescents, addressing this question is of great importance. The second aim of the research is to analyze mediators of reduced suicidal and self-injurious behaviors in adolescents. 170 adolescents at two sites (Seattle and Los Angeles) will be randomized to DBT or Individual and Supportive Group Therapy (IGST). Both treatments include 6 months of individual and group treatment and adolescents and a parent complete 5 assessments over a 1-year period.


Eligibility Criteria:
Inclusion Criteria:

1. Current suicide ideation;
2. More than one intentional self-injury or suicide attempt;
3. Has difficulties with emotion and impulsive behavior or has characteristics similar to borderline personality disorder;
4. 13-17 years of age;
5. At least one family member or responsible adult available to participate in assessments and treatment.

Exclusion Criteria:

* Has significant developmental delays
* Has significant current mania, psychosis or life threatening anorexia
* Has a court order for treatment
The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients

The purpose of this prospective cohort study is to investigate whether antithrombotic therapy in the secondary prevention of ischemic stroke increases the risk of the emerging CMBs and whether the change is associated with an increased risk of intracranial hemorrhage, providing an imaging evidence for individualized antithrombotic therapy in such patients.

Cerebral microbleeds（CMBs） is a subclinical lesion caused by microvascular disease in the brain, characterized by microleakage of blood. About 30% of ischemic stroke patients, 40% of the healthy people over 80 years old, and 60% of intracranial hemorrhage patients have microbleeds. With the development of imaging technology, clinically more and more patients have found microbleeds in the brain. How these patients are treated with antithrombotic drugs is not yet clear and is in urgent need of evidence. There are only a few prospective cohort studies to determine whether antithrombotic therapy increases the risk of intracranial hemorrhage in ischemic stroke patients with CMBs, but the results are uncertain. More importantly, whether antithrombotic therapy increases the incidence of the emerging CMBs, and whether the change of increased microbleeds is associated with increased intracranial hemorrhage has not been reported.

Eligibility Criteria:
Inclusion Criteria:

1. Patient age ≥18 years;
2. Acute ischemic stroke patient confirmed by imaging;
3. Time of onset: within 3 months;
4. Baseline SWI sequence is completed before starting the secondary prevention of ischemic stroke;
5. Baseline SWI sequence must have at least one CMB ;
6. NIHSS≤10

Exclusion Criteria:

1. MRI contraindication;
2. Hemorrhagic transformation after acute Ischemic stroke;
3. Contraindication for antiplatelet or anticoagulation therapy;
4. Severe head trauma or intracranial hemorrhage occurred in the past six months;
5. obvious coagulopathy;
6. Other intracranial lesions associated with (such as tumor, cerebral vascular malformation);
7. other unqualified patients judged by the investigator
Incidence of Retinopathy and Associated Risk Factors in Children and Young Adults With Type 1 Diabetes in Denmark

The objective of this study is to clarify the current diabetic status, including development of complications, in a nationwide cohort of type 1 diabetics, who were last examined together in a large study in 1995. These youngsters were originally participating in a nationwide study of children with type 1 diabetes in Denmark back in 1986. The investigators will try to establish risk factors for developing diabetic retinopathy. The investigators will have emphasis on retinal vessel geometry and the possibilities for early detection of reversible retinal changes, and prediction of other vascular complications.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the follow-up study in 1995

Exclusion Criteria:

* No retinal photographs from 1995
Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies

Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15\~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (\<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.

Fludarabine and busulfan was considered as myeloablative but reduced toxicity regimen and became as the mainstay of conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The disease relapse remained as major cause of treatment failure. In general, the cumulated incidence of relapse (CIR) is about 15\~20% dependent on the risk of patients undergoing allogeneic stem cell transplantation (allo-HSCT). Conditioning regimen with dual alkylating agents such as fludarabine, busulfan and thiotepa (TBF) showed decreased risk of relapse in myeloid malignancies. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan could achieve a low incidence of relapse (2 year CIR \<10%). In this multiple-center randomize study, the aim is to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu vs. Flu-Bu-Mel.

Eligibility Criteria:
Inclusion Criteria:

* acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission
* myelodysplasia syndrome with bone marrow blast \>5% and remaining less than 20% at transplantation
* patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identical related donors
* inform consent provided

Exclusion Criteria:

* AML patients with active CNS or extramedullary diseases
* patients with active viral, bacterial or fungal infection
* patients with hepatitis B virus \>1X103 copy/ml
* patients with abnormal liver function, renal function, respiratory or cardiac dysfunction
* patients with uncontrolled mental disorders
* patients with HIV
Study to See if Platelet Transfusion Stop or Lessen the Effect of the Drug on Platelets

Study to see if platelet transfusion stop or lessen the effect of the drug on platelets

A open label, randomized, crossover and potential parallel, single dose study of ticagrelor 180 mg and acetylsalicylic acid (ASA) in healthy volunteers followed by autologous in vivo platelet transfusion to determine the effects of platelet supplementation on the reversibility of platelet inhibition

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male and/or female volunteers aged 18 to 50 years, inclusive, with suitable veins for cannulation or repeated venipuncture. (Healthy as determined by medical history and physical examination, laboratory parameters, electrocardiogram (ECG) perform
* Have a body mass index (BMI) between 18 and 35 kg/m2 (inclusive) and weigh at least 50 kg and no more than 120 kg

Exclusion Criteria:

* ADP induced platelet aggregation \<60% prior to platelet apheresis
* History of peptic ulcer disease Healthy volunteers with a propensity to bleed (eg, due to recent trauma, recent surgery, active or recent gastrointestinal bleeding or moderate hepatic impairment)
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
* Current smokers, those who have smoked or used nicotine products within the previous 3 months and those who tested positive for cotinine at screening or at admission to the study center
Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

The aim of the present trial is to assess the prospective results of protocol-based interstitial pulsed-dose-rate (PDR) brachytherapy with interstitial hyperthermia (iHT) in a group of selected patients where salvage surgery with clear resection margins was not possible.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed recurrent carcinoma of the head and neck region
* Stage rcT1-3
* Tumor anatomy and location suitable for brachytherapy techniques.
* cN0/pN0 or rpN+ \& R0 with \<3 pos. LND \& without invasion of capsula.
* M0
* ECOG 0-2
* Previous radiation therapy up to at least 50 Gy
* Previous radiation therapy completed more than 6 months ago
* Written study-specific informed consent

Exclusion Criteria:

* cT4
* rpN+ with \>2 pos. LND or invasion of capsula
* Pregnant or lactating women
* Collagen vascular disease
* The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatica or similar
* Psychiatric disorders
Effect of Core Stability Versus Conventional Exercise for Functional Ambulation of Calf Muscle

Knee osteoarthritis (KOA) is a degenerative joint disease causing pain, stiffness, and reduced quality of life. While treatments often focus on drugs or surgery, noninvasive exercises like core stabilization and ankle/foot strengthening show potential but lack comparative studies. Understanding anatomical factors like Achilles tendon (AT) thickness is crucial for targeted rehabilitation, though measurement reliability remains an issue. This study aims to compare the effects of these exercises on KOA symptoms and evaluate the use of digital calipers for AT thickness measurement, aiming to enhance clinical management of KOA.

The objective of the study is:

1. To determine the interrater and intrarater reliability of digital calliper to measure the side to side Achilles tendon thickness.
2. To determine the impact of 24 sessions of core stability translated in gait ambulation.
3. determines the relationships between Achilles tendon thickness (ATT), knee symptoms/functions, and foot alignment in knee OA patients, considering their interconnected biomechanical nature.
4. compare the effects of core stability and ankle-foot strengthening exercises on clinical outcomes in KOA patients

Eligibility Criteria:
Inclusion Criteria:

* 40 years old, had been diagnosed with KOA based on ACR, and

  * having Grade II or III osteoarthritis by K/L criteria.

Exclusion Criteria:

* post-traumatic osteoarthritis
* lower limb sensorimotor dysfunction,
* Any history of knee fracture/ tumor/ infection and hip/knee surgery.
* Total Knee Replacement patients.
* Neurological disease.
* Patient received physical therapy treatment from last 6 months.
* Inflammatory Arthritis (Rheumatoid Arthritis)
* Use of any intra-articular injections (steroid/ hyaluronic acid/ PRP.) from last 3-6 months.
A Dose Conversion Study of Epoetin Alfa in Subjects With the Anemia of Chronic Kidney Disease.

The purpose of this study was to evaluate hemoglobin stability in subjects who had received darbepoetin alfa for a minimum of 3 months prior to study entry who were then converted to epoetin alfa at the same dosing frequency to maintain a hemoglobin level of 12 plus or minus 1 g/dL (range 11-13- g/dL).

This was a prospective, multicenter study in subjects with chronic kidney disease. The study was designed to address hemoglobin stability after drug conversion to epoetin alfa in subjects previously receiving darbepoetin alfa therapy.

The study was to enroll approximately 180 subjects with chronic kidney disease. Eligible subjects were those with chronic kidney disease who were receiving darbepoetin alfa every two, three, or four weeks for a period of 3 months or more and who had a stable hemoglobin (Hb) level at study entry of 12 g/dL (plus or minus 1 g/dL (11-13 g/dL). Subjects receiving darbepoetin alfa every 2, 3 or 4 weeks were switched over to epoetin alfa which they received at the same dosing frequency ( every 2, 3 or 4 weeks) upon study entry and throughout the 24 week study period. Clinical safety was assessed for the occurrence and severity of adverse events. Blood tests (Complete Blood Count, platelets, reticulocyte count, iron, were assessed at pre-determined intervals throughout the study. Vital signs (e.g. Blood pressure) were checked at each visit. Subjects received epoetin alfa at the same dosing frequency that they had previously received darbepoetin alfa. Subjects received 20,000 Units (U) epoetin alfa subcutaneously (SC) every two weeks; 30,000 U epoetin alfa SC every 3 weeks; or 40,000 U epoetin alfa SC every 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic kidney disease defined as serum creatinine of 1.5 to 6.0 mg/dL for women and 2.0 to 6.0 mg/dL for men
* glomerular filtration rate (GFR) within 15-60 mL/min
* Subjects on darbepoetin alfa for 3 months or more and with a stable entry hemoglobin level of 12 (plus or minus 1 g/dL
* range 11-13 g/dL)
* Subjects receiving darbepoetin alfa on an every two, three, or four week dosing schedule
* female subjects with a reproductive potential must have a negative ruine pregnancy test within 7days of the first dose of study drug.

Exclusion Criteria:

* No uncontrolled high blood pressure as assessed by the primary physician
* No known hypersensitivity to mammalian cell-derived products
* No known hypersensitivity to human albumin
* Not receiving dialysis or scheduled to receive dialysis during the course of the study
* No severe congestive heart failure (New York Heart Association Class IV)
* No known severe stable or unstable coronary artery disease.
Oligodendrocyte Progenitor Cell Culture From Human Brain

Recent developments in the understanding of stem- and progenitor cell differentiation raises hopes that brain damage in chronic neurological diseases may become repaired by systemic or focal transplantation of such cells. Clinical trials of stem- or progenitor cell transplantation in multiple sclerosis are currently premature. The researchers developed a protocol for human oligodendrocyte progenitor cell culture from human brain for the treatment of demyelinating disease.

Oligodendrocyte progenitor cell line were cultures and will be transplanted into the patient with Multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 20-65 years of age
* Informed consent
* Has elective craniotomy surgery

Exclusion Criteria:

* HIV, hepatitis, and other central nervous system (CNS) infections
* Dementia, Alzheimer disease, and neurodegenerative disease
The Efficacy of Tongue Exercises on Swallowing Function in the Elderly with Mild Cognitive Impairment

The purpose of this study is to explore the effects of tongue muscle strength and resistance exercises on dysphagia, tongue muscle strength, oral hygiene, repetitive saliva swallowing, nutrition, depression, and swallowing-related quality of life in frail elderly people with mild cognitive impairment in the community.

This is a longitudinal research design using cluster randomization. Participants were randomly divided into three groups by computer: Experimental Group 1 received tongue resistance exercises; Experimental Group 2 received both tongue strengthening exercises and tongue resistance exercises; and the control group received oral and cheek bulging exercises.

Recruitment was carried out in nursing homes, day passport centers, and community care centers in New Taipei City and Taoyuan City, Taiwan. The subjects were elderly people aged 65 years or older with cognitive impairment and frailty, recruited from November 19, 2021, to January 25, 2024.Participants were randomly divided into three groups by computer, 30 people per group, Group 1 received tongue resistance exercises, Group 2 received both tongue strengthening exercises and tongue resistance exercises, Group 3: control group received oral and cheek bulging exercises.

The exercise intervention is divided into two stages. After completing the pre-test (T1), the first stage of 12 weeks of exercise begins, with evaluations conducted at the 4th week (T2), 8th week (T3), and 12th week (T4). After a 12-week rest period (T5), the second phase of Boosters exercise is conducted for another 12 weeks, followed by an immediate post-test (T6) and a final evaluation after another 12 weeks of rest (T7). Participants received exercise 6 days a week, 3 times a day (before meals), with each session lasting 30 minutes.

Before conducting the study, all participants received a complete explanation of the purpose, risks, and procedures of the investigation, and provided written informed consent. Procedures were in accordance with the ethical standards of the committee on human experimentation at the institution where the work was conducted, and this study was approved by the Institutional Review Board.

Eligibility Criteria:
Inclusion Criteria:

* A. Elderly individuals aged 65 years and above.
* B. Frailty assessment in older adults: Score of at least 1 point.
* C. Cognitive function assessment: Score of \>=16 for individuals with no education; \>=20 for those with elementary education; \>=24 for those with junior high school education or higher.

Exclusion Criteria:

* A. Severe communication barrier.
* B. Unable to move independently or requires assistance.
* C. Unable to raise head or neck.
* D. Recent use of anticholinergic medications, asthma medications, or central nervous system depressants (Benzodiazepines).
* E. Aspiration pneumonia.
* F. Tracheostomy in place.
* G. Neuromuscular disorder.