cyrilzakka/clinical-trials huggingface dataset:
Correlation Between the Amplitude of Ankle Dorsiflexion and Occurrence of Patellofemoral Pain Syndrome

The aim of this study was to verify the clinical reliability of ankle dorsiflexion range of motion (ADROM) measurement with weight bearing (WB) using an app on the smartphone (iHand) and to verify if there is correlation between the limitation of the ADROM and the PFP.

The change in lower extremity movement pattern has been previously associated with severe knee disorders, including anterior cruciate ligament rupture, patellar tendinopathy, iliotibial band syndrome, and patellofemoral pain (PFP). The aim of this study was to verify the clinical reliability of ankle dorsiflexion range of motion (ADROM) measurement with weight bearing (WB) using an app on the smartphone (iHand) and to verify if there is correlation between the limitation of the ADROM and the PFP.

Eligibility Criteria:
Inclusion Criteria:

* volunteers with a history of patelofemoral pain
* presence of image (lesion) in cartilage tissue in Nuclear Magnetic Resonance
* knee dynamic valgus during the single leg squat test and step down test (clinical tests)

Exclusion Criteria:

* acute knee lesion
* acute ankle lesion
* surgical procedures before six months ago
Clinical Evaluation of Nanoionomer Filling in Primary Teeth

This clinical trial was performed to evaluate the nano-filled resin modified glass ionomer (RMGI) -with a brand name of "Ketac Nano"- as a filling material for the treatment of caries in primary teeth. Children aged 5-8 years were selected and treated with either Ketac Nano or another conventional RMGI called Vitremer. Then, the treated children were evaluated at baseline, after one yeat and after two years. The hypothesis to be tested in the present study was: The clinical performance of nano-filled RMGI (Ketac Nano) in class I primary molars will differ from that of its preceding conventional RMGI (Vitremer).

First, shear bond strength of each material to primary molars dentin specimens were measured (n=10) using a notched-edge crosshead. Independent sample t-test was used for statistical analysis. Then, a split mouth designed clinical trial was performed in which nano-filled RMGI; Ketac Nano (KN) and conventional RMGI; Vitremer (VR) were used to restore class I cavities of primary molars. Each material group (n=30) was evaluated according to the modified United States Public Health Service (USPHS) regarding marginal discoloration, marginal adaptation, color match, anatomic form and recurrent caries, at baseline, after one year and after two years. Wilcoxon signed- rank test and Chi-square test were used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* The presence of a bilateral identical pair of primary molars in the same arch containing initial occlusal caries (a minimum of two pits or fissures without any cusp destruction).

Exclusion Criteria:

* Handicapped or uncooperative children and children with extensive or rampant caries.
Study of Remdesivir in Participants Below 18 Years Old With COVID-19

The goals of this clinical study are to learn more about the study drug, remdesivir, and how safe it is in participants less than 18 years old with coronavirus disease 2019 (COVID-19).

Pediatric participants will be enrolled as follows:

Pediatric participants ≥ 28 days to \< 18 years old:

* Cohort 1: ≥ 12 years to \< 18 years and weight ≥ 40 kg
* Cohort 2: ≥ 28 days to \< 18 years and weight ≥ 20 kg to \< 40 kg
* Cohort 3: ≥ 28 days to \< 18 years and weight ≥ 12 kg to \< 20 kg
* Cohort 4: ≥ 28 days to \< 18 years and weight ≥ 3 kg to \< 12 kg
* Cohort 8: \< 12 years and weight ≥ 40 kg

Term neonatal participants 0 days to \< 28 days old:

* Cohort 5: ≥ 14 days to \< 28 days of age, gestational age \> 37 weeks and weight at screening ≥ 2.5 kg
* Cohort 6: 0 days to \< 14 days of age, gestational age \> 37 weeks and birth weight ≥ 2.5 kg

Preterm neonates and infants 0 days to \< 56 days old:

* Cohort 7: 0 days to \< 56 days of age, gestational age ≤ 37 weeks and birth weight ≥ 1.5 kg

Eligibility Criteria:
Key Inclusion Criteria:

* Aged \< 18 years of age who meet one of the following weight criteria (where permitted according to local law and approved nationally and by relevant institutional review board (IRB) or independent ethics committee (IEC)).

  * a) Cohort 1: ≥ 12 years to \< 18 years of age and weight at screening ≥ 40 kg
  * b) Cohorts 2-4: ≥ 28 days to \< 18 years of age and weight at screening ≥ 3 kg and \< 40 kg
  * c) Cohort 5: ≥ 14 days to \< 28 days of age, gestational age \> 37 weeks and weight at screening ≥ 2.5 kg
  * d) Cohort 6: 0 days to \< 14 days of age, gestational age \> 37 weeks and birth weight of ≥ 2.5 kg
  * e) Cohort 7: 0 days to \< 56 days of age, gestational age ≤ 37 weeks and birth weight of ≥ 1.5 kg
  * f) Cohort 8: \< 12 years of age and weight at screening ≥ 40 kg
* Severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR).
* Hospitalized and requiring medical care for coronavirus disease 2019 (COVID-19).

Key Exclusion Criteria:

* Concurrent treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 \< 24 hours prior to study drug dosing.
* Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 X upper limit of normal (ULN).
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2 using Schwartz formula for individuals ≥ 1 year of age.
* Creatinine above protocol specified thresholds for \< 1 year of age.
* Positive pregnancy test at Screening only for female of child bearing potential. Note: If female participants who become pregnant during the study or are discovered to be pregnant after receiving at least one dose may continue study drug, after discussion with the investigator.
* On renal replacement therapies (intermittent hemodialysis (iHD), peritoneal dialysis (PD), continuous renal replacement therapy (CRRT)).

Note: Other protocol defined Inclusion/Exclusion criteria may apply
An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and ribavirin as part of their treatment.

This is a randomized, double-blind (neither physician nor patients knows the name of the assigned drug), placebo-controlled study of TMC435 in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients in this study will also receive two other drugs for their infection called peginterferon alfa-2a and ribavirin. The purpose of the study is to investigate if TMC435 is superior to placebo in reducing hepatitis C virus to an undetectable level 24 weeks after the end of treatment. For the first 12 weeks, patients will take TMC435 or placebo, plus peginterferon alfa-2a and ribavirin. For the next 12 weeks, patients will take peginterferon alfa-2a and ribavirin only. After that, some patients will continue to take peginterferon alfa-2a and ribavirin for up to 24 additional weeks. Other patients will stop taking peginterferon alfa-2a and ribavirin. The study doctor will inform each patient about how to take their study medication and when they should stop taking it. After a patient stops taking study medication, they will continue to come to the doctor's office for study visits until a total of 72 weeks after they enroll in the study. The total duration of the study is 78 weeks (including screening). Patients will be monitored for safety throughout the study. Study assessments at each study visit may include but are not limited to: blood and urine collection for testing, ECG assessments (a measurement of the electrical activity of your heart), patient questionnaires, and physical examinations TMC435 will be taken as an oral capsule of 150 mg once per day. Peginterferon (Pegasys ®) will be given as an injection of 180 µg once each week. Ribavirin (Copegus ®) will be taken as a tablet twice each day and the dose will depend on your body weight.

Eligibility Criteria:
Inclusion Criteria:

* Genotype 1 hepatitis C infection (confirmed at screening)
* Have previously received peginterferon-based therapy for at least 24 weeks with documented HCV RNA at last measurement and relapsed within 1 year of last taking medication
* Liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
* Must agree to use 2 forms of effective contraception throughout study (both males and females)

Exclusion Criteria:

* Infection with HIV or non-genotype 1 hepatitis C
* Liver disease not related to hepatitic C infection
* Hepatic decompensation
* Significant laboratory abnormalities or other active diseases
* Pregnant or planning to become pregnant
Combination of Rituximab and NK Immunotherapy for B Lymphoma

The aim of this study is the safety and efficacy of Rituximab plus NK immunotherapy to recurrent B lymphoma.

By enrolling patients with B lymphoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Rituximab and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Comparison of Quality of Life in Patients Undergoing More Intensive Versus Less Intensive Chemotherapy and Radiation Preceding a Bone Marrow Transplant

This study will examine the quality of life of patients undergoing bone marrow transplantation to treat a blood disease. It will look at how this therapy affects many areas of life, including for example, personal relationships, work, and general emotional state. The information gained may lead to improved ways of dealing with problems that may arise before or during treatment.

Patients receiving bone marrow stem cells donated by a family member may participate in this study. They will be interviewed before treatment begins and will complete questionnaires at the following intervals:

1. day of admission to the hospital
2. day of the transplant
3. 30 days after the transplant
4. 100 days after the transplant
5. 1 year after therapy
6. 2 years after therapy

All questionnaires to be completed after discharge from the hospital will be scheduled during a regular follow-up visit. Each questionnaire takes about 15 to 20 minutes to complete. The information provided is confidential and will not be shared.

Clinical research in blood stem cell and bone marrow transplantation documents improvements in disease free intervals, disease free survival, and the severity of treatment related toxicities. However, it is important for patients and families to know the quality of life (QOL) they can expect following an allogeneic transplant. In this longitudinal study we will compare the QOL of patients undergoing a non-myeloablative allogeneic peripheral blood stem cell transplant (A-PBSCT) prospectively with that of a myeloablative A-PBSCT. Subjects (n=106) over the age of 18 will be enrolled. Measures of quality of life (Medical Outcomes Study Short Form-MOS SF-36 and Functional Assessment of Cancer Therapy-General and Bone Marrow Transplant - FACT-G and FACT-G/BMT) and symptom distress (Symptom Distress Scale - SDS) will be administered prior to transplant (baseline) and at set interval post transplant. Data will be analyzed using repeated measures analysis of variance and regression analysis.

Eligibility Criteria:
INCLUSION CRITERIA:

Male or female subjects 18 years of age or older.

Able to read English or Spanish.

Hematological disease requiring A-PBSCT.

Signed informed consent for QOL study.
EXCEL: Exercise for Cancer to Enhance Living Well

Project EXCEL will provide community or online exercise programs to rural and remote and under-served cancer survivors, as well as encourage participants to become life-long exercisers. Exercise is an evidence-based self-management strategy that benefits all cancer survivors. However, most cancer survivors who live in remote or rural places don't have adequate opportunities to be involved in exercise programs that are tailored to their needs.

As cancer survivorship numbers grow, a focus on positive health in survivorship is essential. Exercise is an evidence-based effective self-management strategy that benefits all cancer survivors (CS). However, the majority of research and the limited development of evidence-based clinical or community programs in exercise and cancer has been conducted almost exclusively in urban academic and clinical settings, with very limited implementation outreach to "hard to reach" CS.

In this proposed cancer exercise hybrid implementation effectiveness research, over 5 years we will use an integrated knowledge translation approach to move the current evidence-base that clearly supports the role of exercise in cancer survivorship, into sustainable and effective community-based or online settings that will optimize the delivery of exercise to rural/remote and underserved CS (RCS). Implementing and evaluating the proposed Exercise Oncology Survivorship (EOS) partnership model will result in a sustainable resource to support the implementation and delivery of exercise oncology programs in rural Canadian communities.

Investigators will work to develop lasting referral pathways between cancer care clinics and local fitness professionals. These fitness professionals will have additional cancer specific training to ensure they can effectively and safely deliver the program. Eligible and consenting participants will be screened for exercise safety, and following fitness testing will be triaged to appropriate exercise programming. If, due to COVID-19 public health restrictions, community based programming cannot occur, the exercise sessions will be delivered online by fitness professionals.

Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of cancer
* are over the age of 18 years
* are able to participate in mild levels of activity
* are about to have treatment, are currently having treatment, or have had cancer treatment within the last 5 years
* can read/write in English
* can access online programs, if necessary, to participate in the exercise programs.

Exclusion Criteria:

* unable to read/write in English
* are unable to participate in exercise
* for online programs, do not have internet or computer access
Comparison of the Effects of Bilateral Transversus Abdominis Plane Block and Bilateral Quadratus Lumborum Block on Postoperative Analgesia in Patients Undergoing Midline Laparotomy

Midline incisions provide easy, rapid and excellent exposure of the abdominal cavity and are particularly used for complex, diagnostic or emergency procedures.

However, midline incisions transect the nerve fibers passing in the mediocaudal direction of the abdominal wall, which causes more postoperative pain than other incisions.

Postoperative pain and delayed return of bowel function are thought to be the main factors that prevent early recovery and discharge.

or surgical procedures where parietal pain is the main component of postoperative pain, TAPB can be used as a simple and effective analgesic technique with the added advantage of preserved motor and bladder function.

Quadratus lumborum block can be used as an analgesic technique in all surgeries such as proctosigmoidectomy, hip surgery, above-knee amputation, abdominal hernia repair, breast reconstruction, colostomy closure, radical nephrectomy, lower extremity vascular surgery, total hip arthroplasty, laparotomy and colectomy.

Our study aimed to compare the effects of bilateral oblique subcostal TAPB with bilateral QLB2 and QLB3 performed under ultrasound guidance in midline incision laparotomies on total opioid requirement in the first 24 hours postoperatively, early postoperative pain intensity, time to first rescue analgesic requirement, nausea, vomiting and pruritus.

To evaluate this hypothesis, we compared TAPB and QLB in a prospective, randomized, single-center clinical study. The primary endpoint of our study was the comparison of total morphine consumption in the first 24 hours postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Laparotomy with midline incision
* General anesthesia will be applied
* 18-70 years old
* ASA 1-3
* BMI of 18-30 kg/m2
* Literate
* Without cognitive impairment
* Patients who approved the informed consent form

Exclusion Criteria:

* Under 18 years old
* Over 70 years old
* ASA 4 and above
* Cognitive impairment
* İlliteracy
* Vision and hearing problem
* Infection at the injection site
* Coagulopathy
* Peripheral neuropathy
* Local anesthetic allergy
* Patients who do not want to be included in the study
AAV2/8-LSPhGAA (ACTUS-101) in Late-Onset Pompe Disease

Open-label, ascending dose trial of ACTUS-101 administered intravenously.

This study will be a prospective, open-label trial designed to objectively assess the safety and bioactivity of ACTUS-101 in subjects diagnosed with Pompe disease, which is caused by a defect in acid α-glucosidase (GAA) gene. ACTUS-101 is intended to enable expression of a functional copy of the GAA gene in subject's hepatocytes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Pompe disease by blood or skin fibroblast GAA assay and two pathogenic variants in the GAA gene,
* Age: Greater than or equal to 18 years at enrollment.
* Subjects are capable of giving written informed consent.
* Able to walk at least 100 meters on the 6MWT (with assistive devices permitted).
* FVC within the range of 30% to less 90% (inclusive) of predicted in the upright position.
* Subjects with a confirmed diagnosis of LOPD who have been treated with ERT for at least 104 weeks (inclusive) immediately preceding screening and receiving a stable dose of ERT for the 52-week period immediately preceding dosing.

Exclusion Criteria:

* Invasive ventilation required or noninvasive ventilation required while awake and upright.
* FVC \<20% of predicted (supine).
* Received any live vaccination 2 months prior to study Day 1.
* Pregnant or nursing mothers.
* Serology consistent with exposure to HIV, or serology consistent with active hepatitis A, B or C infection. Any active liver disease.
* Active infection based upon clinical symptoms.
* Having started respiratory muscle strength training in the last 6 months prior to study day 1 or having discontinued respiratory muscle strength training in the 6-month period preceding study day 1, or having started respiratory strength training greater than 6 months prior to study day 1 and unwilling to continue for the first year of study participation.
* Received an investigational drug or participated in another interventional study within 90 days prior to Study Day 1. Additionally, subjects cannot participate in any other interventional clinical trial throughout the first 78 weeks after receiving ACTUS-101.
Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC

The goal of this non-interventional study is to evaluate quality of life (QoL) in adult patients with newly diagnosed IDH1 R132-mutated AML who are not eligible to receive standard induction chemotherapy and who are treated with ivosidenib in combination with azacitidine in a real-world setting in Germany.

The main questions it aims to answer are:

* Evaluate QoL by validated and widely used Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) questionnaire and European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire during treatment and follow-up period
* Assesment of effectiveness in routine treatment (e.g. overall survival, event-free survival, overall response rate)
* Assessment of drug safety (all adverse events)
* Description of treatment reality in detail


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Newly diagnosed Acute Myeloid Leukemia (AML).
* Having an isocitrate dehydrogenase 1 (IDH1) R132 mutation.
* Not eligible to receive standard induction chemotherapy.
* Decision for treatment with ivosidenib in combination with azacitidine as per current SmPC.
* Signed written informed consent\*

  \*Patients are allowed to be enrolled up to 6 weeks after ivosidenib plus azacitidine dose
* For patients participating in PROs: Willingness and capability to participate in PRO assessment in German language
* Other criteria according to current SmPC.

Exclusion Criteria:

* Participation in an interventional clinical trial within 30 days prior to enrollment or simultaneous participation in an interventional clinical trial except for the follow-up period.
* Patients unable to consent
* Other contraindications according to current SmPC.
High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study

Although high-intensity training (HIIT) is widely used in the rehabilitation of patients with chronic obstructive pulmonary disease (COPD), the optimal duration of intervals in terms of patient tolerability and fidelity is unknown.Thus, we will examine the fidelity and tolerability of the two most commonly used HIIT protocols, the classical so-called 4x4min vs. 10x1min in patients with moderate to severe COPD.

12 patients with severe to moderate COPD will be included in the study, where two different HIIT interventions will be compared with regards to fidelity and tolerability. Baseline measurements will be performed to assess fitness and cardiopulmonary health status for the included patients. The baseline measurements include a medical health interview and examination (blood pressure, heart rate, ECG), a maximal oxygen consumption (VO2max) test, lung function testing (dynamic spirometry, whole body plethysmography, diffusing capacity), and an assessment of body composition. The following two visits consist of two different HIIT protocols.

Each training session is evaluated by Borg Scale (5) and the Likert Scale (6), as well as time spent in with a heart rate above 85% of maximum. Each HIIT session is separated by at least a 3-day wash-out period.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* 18-80 years
* Moderate to severe COPD(GOLD stage II to III)

Exclusion Criteria:

* Known ischaemic heart disease
* Known heart failure
* Previous or current coronavirus disease 2019 (COVID-19)
* Dementia or other severe neurological disease
* Known vascular
* Symptoms of disease within 2 weeks prior to the study
* Pregnancy