cyrilzakka/clinical-trials huggingface dataset:
Eﬀects of Reparel™ Knee Sleeve on Knee Osteoarthritis

The goals of treating knee osteoarthritis (OA) is to improve or maintain quality of life, mobility and function, pain relief, and improve inﬂammation. The diﬀerent treatment options for knee OA have been extensively studied and implemented, but the optimum treatment is still undecided. There is a belief that anti-inﬂammatory sleeve technology may be beneﬁcial in treating knee OA. The purpose of this study is to determine the clinical eﬀects of Reparel™ knee sleeve regarding mobility, functionality, and pain outcomes in managing knee OA.

Standard knee compression sleeves have been described throughout literature to provide beneﬁts in pain and functional outcomes through support of the ligamentous structures. Bracing is both an eﬀective and economical treatment for osteoarthritis and serves as a crucial option in the treatment of knee OA to aid in both delaying surgery and as options for young patients, or patients that are not ideal surgical candidates. Although knee sleeves are commonly utilized treatment modalities, there is a signiﬁcant paucity of literature on the eﬀects of thermo-active braces in the treatment of knee OA. This investigation will examine this non-operative treatment modality and study it eﬀect for the treatment of knee OA specifically by investigating the Reparel Knee Sleeve. The Reparel Knee Sleeve is a Class I Medical Device (510(k) exempt) and used in general sports medicine practice for the alleviation of knee pain. The authors expect that the Reparel thermos-active knee sleeve will have a signiﬁcant eﬀect on pain relief from knee OA.

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis visible on knee radiograph
* patient opting for non-surgical treatment
* no corticosteroid knee injection for 90 days prior to consent
* no corticosteroid knee injection for 90 days following consent

Exclusion Criteria:

* bilateral symptomatic knee osteoarthritis
* prior surgery on the knee of interest
* hardware present on the knee of interest
* gross instability detected on physical exam
* malignancy in the knee of question
Auriculotherapy on Older People With Insomnia

Objective To determine the optimum treatment protocol of auriculotherapy (AT) on the improvement of sleep conditions and quality of life on the elders with insomnia.

Research hypothesis The use of combined LAT plus MAT is more effective than MAT/LAT alone on the improvement of sleep conditions and quality of life in the elderly with insomnia.

Design and subjects This is a 3-arm double-blinded randomised trial. Subjects aged ≥65 and exhibit poor sleep conditions are recruited.

Interventions Group 1: Subjects will receive a deactivated laser treatment followed by MAT. Group 2: Subjects will receive LAT and placebo MAT. Group 3: Subjects will receive a combined approach (LAT plus MAT).

The treatment will be delivered 3 times/week, with a 6-week treatment period, on seven specific auricular points.

Main outcome measures Sleep conditions and quality of life will be evaluated at baseline; end of 6-week treatment; and at 6-week, 12-week, and 6-month follow-up periods.

Data analysis Descriptive statistics, chi-square analysis, ANOVA, paired t-test, and mixed effect modeling will be conducted as appropriate.

Expected results This study would advance our knowledge the optimum treatment protocol of AT in the improvement of the sleep conditions of the elderly population.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers who are aged 65 or above
* Report having difficulty falling or staying asleep, and/or frequent nocturnal awakenings
* At least three nights per week, sleep disturbance has lasted for a minimum of six months
* Their sleep is of poor quality as indicated by a PSQI score greater than five.

Exclusion Criteria:

* profound physical illness, such as stroke
* diagnosed with obstructive sleep apnoea
* having a hearing aid or pacemaker in situ (to prevent the magnetic pellets from interfering with the devices)
* receiving AT within the preceding 6 months,
* suffering from aural injuries or infections, and
* inability to understand instructions or give consent.
Study to Assess the Efficacy and Safety of Dysport® in Upper Back Myofascial Pain Syndrome

The main purpose of this study is to determine which is the best dose of a drug known as Dysport to give when treating one's type of upper back pain. The study will also examine the side effects of this treatment and its overall effect on one's disorder.


Eligibility Criteria:
Inclusion Criteria:

* Moderate-severe pain in upper back
* Myofascial pain syndrome for more than 6 months
* Active trigger points in upper back

Exclusion Criteria:

* Fibromyalgia and other non-myofascial pain conditions of upper back
* Duration of myofascial pain syndrome no longer than 24 months
* Steroid injections during previous 3 months
* Anaesthetic injection at trigger points during previous 1 month
Experience With Topical Acne Treatment

Acne is a chronic condition that typically requires the use of multiple medications.1 Medication adherence is especially challenging for patients with chronic diseases and often decreases over time, especially for those using topical medications.1 Nonadherence can result in multiple negative effects including treatment failure, increased healthcare costs, and decreased quality of life. Primary nonadherence refers to problems acquiring and starting treatment. Challenges to this form of nonadherence include a lack of knowledge, misunderstanding of usage, poor communication with provider, increased cost, and fear of side effects.2 Secondary nonadherence refers to when the patient does not use the medication as prescribed. Hurdles to secondary nonadherence include delayed results, increased complexity of treatment plan, adverse effects, busy lifestyle, and inconvenience.2


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients ≥18 years of age
2. Patients with a current diagnosis of acne
3. Patients who live in the US,
4. Patients have sufficient command of the English language

Exclusion Criteria:

1. Patients less than the age of 18
2. Patients without a current diagnosis of acne
3. Patients who do not live in the US
4. Patients without a sufficient command of the English language
Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.

The study was terminated when all ongoing participants had been treated for at least 5 years.

Participants who completed the main FE200486 CS14 study initially continued with the same dose in the FE200486 CS14A extension study. A protocol amendment changed the dosage to 160 mg (40 mg/mL) for all study participants.

The data include data from the participants who participated in both the main study (FE200486 CS14; NCT00116779) and the extension study FE200486 CS14A.

Eligibility Criteria:
Inclusion Criteria:

* Has given written consent prior to any study-related activity being performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
* Has completed study FE200486 CS14 through visit 22.

Exclusion Criterion:

* Has been withdrawn from the FE200486 CS14 study.
AVEIR DR Coverage With Evidence Development (CED) Study

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).

This CED study utilizes a real-world evidence (RWE) method merging multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir DR LP health outcomes among Medicare beneficiaries.

The study will enroll all Medicare patients with continuous claims data implanted with the Aveir DR LP system or a dual-chamber transvenous pacemaker system from any manufacturer.

Due to the RWE data collection methods used in this study, a central institutional review board (IRB) approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.

Eligibility Criteria:
Inclusion Criteria:

* Medicare beneficiaries implanted with an Aveir DR leadless pacemaker on or after the study start date (i.e., the date of Aveir DR market approval) will be included in the study.

OR

Medicare beneficiaries implanted with a full system (e.g. lead and generator) dual-chamber transvenous pacemaker on or after the study start date

Exclusion Criteria:

None
Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer

The goal of this randomized controlled trial is to investigate whether ctDNA methylation is a more precise indicator to guide postoperative adjuvant chemotherapy in stage Ill colorectal cancer. The main questions it aims to answer are:

1. Whether ctDNA methylation-guided escalation strategy is superior to standard treatment for stage III high-risk CRC patients.
2. Whether ctDNA methylation-guided de-escalation strategy is non-inferior to standard treatment for stage III low-risk CRC patients.

325 cases were included in the high-risk cohort (T4 and/or N2) and 665 cases were included in the low-risk cohort (T1-T3, N1). Then patients in each cohort were randomly assigned to ctDNA-guided treatment (ctDNA-guided group) and standard treatment (standard treatment group) in a ratio of 2:1. The standard treatment group and ctDNA-negative group in the high-risk cohort were treated with XELOX regimen for 6 months, and the ctDNA-positive group in the high-risk cohort was treated with cmFOLFOXIRI regimen for 6 months. The standard treatment group and the ctDNA-positive group in the low-risk cohort were treated with XELOX regimen for 3 months, while the ctDNA-negative group in the low-risk cohort did not receive adjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old ≤ age \< 75 years old.
2. Stage III (T1-4, N1-2, M0) colorectal cancer patients.
3. Patients who can undergo R0 resection.
4. ECOG score 0 \~ 2.
5. Expected survival ≥ 6 months.
6. No history of other malignant tumors.
7. Voluntarily participate in this study and sign the informed consent. If the subject does not have the ability to read the informed consent (e.g., illiterate subjects), a witness must witness the informed process and sign the informed consent.

Exclusion Criteria:

1. Patients who have received neoadjuvant chemotherapy.
2. Known high clinical risk of adjuvant chemotherapy.
3. Patients with clear contraindications to adjuvant chemotherapy (i.e. due to physical condition, comorbidities, active second cancer, or age).
4. Patients who are unable to undergo subsequent chemotherapy due to other reasons (travel distance, compliance).
5. Vulnerable groups, including people with mental illness, people with cognitive impairment, critically ill patients, minors, pregnant women, etc.
6. There are any other circumstances that the researcher deems unsuitable for inclusion.
Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease (ETON-Study)

Huntington's disease (HD) is an inherited autosomal dominant, progressive neurodegenerative disease. Clinically, HD is characterized by a triad of movement disorders, cognitive impairments and psychiatric disturbances. These symptoms represent a tremendous burden for patients and caregivers. HD is a fatal disorder with neither cure, nor evidence-based standard therapy available.

The green tea polyphenon (2)-epigallocatechin-3-gallate (EGCG) was shown to have beneficial effects in cell and animal models of HD. The aim of this study is to evaluate the efficacy and tolerability of EGCG in HD.

The investigators hypothesize that Sunphenon EGCG administered at a maximal daily dose of 1200 mg compared to placebo during a period of 12 months improves cognition in patients with HD. As primary outcome measure, the change of cognitive functions (as measured by the Unified Huntington's Disease Rating Scale (UHDRS)-Cognition composite score of Stroop test, Verbal fluency \& Symbol Digit Modalities Test) after 12 months in comparison to Baseline was defined.

The investigators further expect a positive influence of EGCG on other clinical manifestations of HD, measurable effects of EGCG on HD biomarkers and good safety and tolerability of EGCG in HD patients.


Eligibility Criteria:
Inclusion Criteria:

* Chorea Huntington (CAG repeats \>39)
* UHDRS TFC \>5
* ≥18 years of age
* Readiness and ability to take oral medication
* Normal liver function laboratory test
* Stable concomitant medication regimen \> 4 weeks prior to Baseline
* Motivation for women with childbearing potential to use highly efficient contraception

Exclusion Criteria:

* Clinically relevant abnormal findings in the ECG, vital signs, physical examination or laboratory values at Screening,
* Long-term treatment with potentially hepatoxic medication
* Any unstable medical condition
* BDI Depression score \> 9 AND clinical diagnosis of depression
* Suicidal tendencies
* Cognitive dysfunction defined as a score \< 23 in the Mini-Mental State Examination (MMSE) at Screening
* Liver or renal disease
* Schizophreniform psychosis within the last 6 months before baseline
* Consumption of more than two cups of black tea per day, consumption of green tea, consumption of \> 500 ml /day of grapefruit juice
* Participation in other Arzneimittelgesetz (AMG) or Medizinproduktegesetz (MPG) studies (three months before and during participation)
* Pregnancy/ lactation
Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal Concentration"

Each year, millions of burn, trauma, or surgical patients worldwide suffer from scarring that severely affects their quality of life and social functioning. In order to prevent and treat diseases related to abnormal scar hyperplasia, clinicians and researchers have adopted various methods, such as scar grinding, surgical resection, drug injection in scar tissue, cryotherapy, laser and so on. However, these methods can not effectively inhibit the abnormal proliferation of scars and improve the adverse effects of existing scars on patients. To date, there is no accepted gold standard for the effective treatment and improvement of abnormal scar tissue.

Through a large number of literature review and preliminary experiments, we summarized and found the following problems: a. The latest research on prevention of scar formation by botulinum toxin type A is only aimed at surgical wounds from the wound type, and there is no research on the scar prevention effect of trauma wounds. b. From the point of view of the study site, there is no study on the effect of scar prevention only on the head, neck, chest and other parts of the body. c. For the research results of botulinum toxin type A in the prevention of scarring, the current research focuses on the effectiveness of botulinum toxin type A at a certain concentration, and does not compare the effects of botulinum toxin type A at various concentrations.Therefore, in order to explore the "optimal concentration" of botulinum toxin type A to prevent scar formation; To explore the effect of botulinum toxin A on scar prevention of traumatic wounds and surgical incisions. To explore the effect of botulinum toxin A on scar prevention in other parts of the body in addition to effective prevention of head, neck and chest scar, We intend to focus on the effectiveness and "optimal concentration" of botulinum toxin type A to prevent scarring, to determine the effect of this means on scar prevention, to provide new ideas for botul

Eligibility Criteria:
Inclusion Criteria:

Patients with emergency trauma and skin swellings, with clear consciousness, no mental retardation or cognitive difficulties, agree to participate in this study, 12≤ age ≤ 65 years old

Exclusion Criteria:

Allergic to botulinum toxin type A;Pregnant, lactating women, patients who plan to get pregnant in the near future;Patients taking retinoic acid, synthetic steroids, amino glycosides antibiotics, calcium channel blockers, cyclosporine and cholinesterase inhibitors; 4 Neuromuscular diseases: such as myasthenia gravis, Lambert-Eaton syndrome, multiple sclerosis;5. Patients with cardiovascular diseases, kidney diseases, liver and other basic diseases; 6 Patients with infection at the injection site; 7 Expect unrealistic patients.
HCV + to HCV - Kidney Transplant

This is a single center study characterizing the experience of administration of 8 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

The goal of this study is to determine if 8 weeks of preemptive and sustained administration of pan-genotypic DAA therapy after kidney transplant prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor kidney to an HCV-naive recipient.

Eligibility Criteria:
Recipient Inclusion Criteria:

* Met MGH transplant center criteria and already listed for kidney transplant
* Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
* No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team
* Able to sign informed consent

Recipient Exclusion Criteria:

* Pregnant or nursing (lactating) women
* HBV positivity (Ag or DNA)
* Any contra-indication to kidney transplantation per center protocol

Donor Inclusion Criteria

* Detectable HCV NAT test
* KDPI score is less than ≤ 0.850
* Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation

Donor Exclusion Criteria

* Confirmed HIV
* Confirmed HBV positive (surface antigen or HBV DNA positive)
* Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)
APPROACH Study: Quality of Life and Outcomes Assessment in Participants With Chronic Hepatitis C (CHC) Treated With Pegylated Interferon (PEG-IFN) Alfa-2a and Ribavirin

This multi-center, observational study will examine the clinical use and outcomes of pegylated interferon (PEG-IFN) alfa-2a and ribavirin combination (PEGASYS RBV) in participants with chronic hepatitis C (CHC). Study visits will be scheduled for baseline, 12, 24 and 48 weeks after baseline. An additional follow-up visit at week 72 will be required for participants with an HCV genotype other than 2 or 3. Quality of life data will be collected at baseline, and at each follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for and scheduled to receive treatment with commercially available PEG-IFN alfa-2a and ribavirin combination
* Serologic evidence of chronic hepatitis C (CHC) infection
* Detectable serum hepatitis C virus - ribonucleic acid (HCV-RNA)
* Negative urine or blood pregnancy test
* Fertile participants receiving treatment to use two forms of effective contraception during treatment and for 6 months after treatment end

Exclusion Criteria:

* Women with ongoing pregnancy or who are breast feeding, or male partners of women who are pregnant
* Received any investigational drug less than or equal to (\</=) 6 weeks prior to enrollment
* Moderate hepatic failure \[Child-Pugh greater than or equal to (\>/=) B\]
* Co-infection with human immunodeficiency virus (HIV) or hepatitis B
* Autoimmune hepatitis
* Known hypersensitivity to alfa interferons, E. coli-derived products, polyethylene glycol, ribavirin and/or any ingredient in the formulation or component of PEG-IFN alfa-2a or ribavirin
Quantitative MRI of Bone Marrow in Patients With Acute Lymphoblastic Leukemia

The study is aimed at assessing changes in the bone marrow of patients from 6 to 18 years old with a diagnosis of acute lymphoblastic leukemia during chemotherapy. Patients of the same age without hematological diseases will be recruited as a control group.

The ratio of fat to water in the bone marrow depends on the cellularity of the bone marrow. In addition to the water/fat ratio in bone marrow there are also other parameters for quantitative MRI assessment. These include the apparent diffusion coefficient (ACD), the T1 relaxation time, mapping of the macromolecular proton fraction. The undoubted advantage of MRI is its non-invasiveness and the ability to assess any localization of the bone marrow.

MRI may become a new non-invasive method for assessing the ratio of fat to cells in the bone marrow in children with hematological malignancies, which can help in making a diagnosis and monitoring the response to therapy.

Eligibility Criteria:
Inclusion Criteria:

1. patients from 6 to 18 years old
2. diagnosis of acute lymphoblastic leukemia during chemotherapy
3. patients of the same age without hematological diseases

Exclusion Criteria:

1. patients less then 6, and older then 18 years old
2. patients who cannot perform the study MRI without general anesthesia
Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy With Temporary Iridium Implant Plus External Beam Radiation in Carcinoma of the Prostate

The specific objective of this study is to compare the relative efficacy of the combination of a temporary iridium implant plus external beam irradiation versus standard external beam irradiation alone in patients with Stage B2 and C prostatic carcinoma. Benefit will be assessed in terms of local recurrence, survival, and toxicity.


Eligibility Criteria:
Inclusion Criteria:

* All patients must have histologically proven adenocarcinoma of the prostate
* The primary tumour should be staged clinically B2 or C as classified by A.J.C. Staging System

Exclusion Criteria:

* Patients requiring transurethral prostatectomy (TURP) prior to diagnosis
* Presence of metastases identified by bone scan, chest x-ray or CT scan of the abdomen and pelvis, or staging lymphadenectomy
* Karnofsky performance status less than 80
* Inadequate laboratory results: i.e. Hb \< 12 gm/litre, WBC \< 3.5 x 10 per litre, platelets \< 100 x 10/litre, urea \> 13 mmol/litre, creatinine \> 220 mmol/litre
* Unfit for surgery for other medical reasons
* Age above 75 years
* Failure to provide written informed consent