cyrilzakka/clinical-trials huggingface dataset:
Sub-study of the Essen Study Centre for the ENTAiER Trial

The present study is a sub-study of the ENTAiER study. The ENTAiER study is a multicenter, randomized, controlled study to evaluate the efficacy and safety of eurythmy therapy and Tai Chi in comparison to standard care in chronically ill older patients with an increased risk of falling.

In addition to the main questions of the ENTAiER study, three additional questions are being investigated at the Hospital Essen-Steele: Proteome and telomere analyses as well as qualitative parameters are recorded and examined. The aim is to compare the changes in proteomes, telomeres and qualitative factors under eurythmy therapy, Tai Chi and standard care in chronically ill older patients with an increased risk of falling.


Eligibility Criteria:
Inclusion Criteria:

* At least 65 years.
* Chronic disease (musculoskeletal, neurological, internal medicine).
* Increased risk of falling (Berg Balance Scale Score 49 or less).
* Medical history: feeling of balance disturbance in the past.
* Independent living at home or in an old people's or retirement home.
* Regular participation in a one-hour event is possible.
* Sufficiently mobile to leave the place of residence independently at least twice a week
* Written declaration of consent.

Exclusion Criteria:

* Disease that restricts participation (e.g. terminal disease, heart failure NYHA III-IV, unstable angina pectoris, uncontrolled seizure disorder, decompensated lung disease that already leads to shortness of breath during light activity, advanced cancer, chemo- or radiotherapy ongoing or during the last 3 months, amputation of one or both legs)
* Complete dependence on the rollator.
* Visual, hearing or speech problems that limit the understanding of the study documents and processes.
* Major cognitive impairment (MoCA score 18 or less).
* High risk of needing individual supervision during group sessions.
* Severe personality disorder or psychiatric illness, alcoholism or other substance dependence affecting the group sessions.
* Life expectancy under 1 year.
* Permanent bed-riddenness expected in less than one year.
* Regular participation in Tai Chi or EYT in the last 6 months.
* Participation in intensive sports activities in the last month (e.g. training in the fitness centre or in sports groups which lead to breathlessness and sweating; skiing, mountaineering in high mountains).
* Patients who cannot understand the nature, meaning and necessities of participating in a study.
* Participation in another clinical trial within 3 months prior to screening for the ENTAiER trial or concurrent participation in another trial that may interfere with this trial.
COVID-2019 Testing and Vaccination Among African American and Latinx Public Housing Residents

This proposal seeks to enhance acceptability and uptake of COVID-19 testing and vaccination to engage African American and Latinx public housing residents in South Los Angeles. Given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally tailored intervention to reduce barriers and implement innovate strategies to engage this population in the uptake of COVID-19 testing and vaccination.

Through the engagement and empowerment of 15 trained COVID-19 health ambassadors, the investigators will jointly implement and evaluate a theoretically based and culturally-sensitive socio-behavioral intervention that will: a) reduce mistrust, fatalistic beliefs, and related psychosocial barriers that hinder COVID-19 testing and vaccination; b) increase receptivity and willingness for uptake of COVID-19 testing and vaccination; and c) assess perceived impact of psychosocial and health outcomes related to COVID-19 testing and vaccination for 310 African American and Latinx public housing residents.

Eligibility Criteria:
Inclusion Criteria:

* Identify as Latino/Hispanic or African American/Black
* Reside in one of the six collaborating public housing
* 18 years old and older
* Speak either English or Spanish

Exclusion Criteria:

* Does not self-identify as African American and/or Black
* Under the age of 18
* Unable to speak English or Spanish
* Does not Reside in one of the six collaborating public housing
A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFα Inhibitor

Study is a double-blind, randomized, placebo controlled, dose escalating study. The primary objective of this study is to evaluate the safety, tolerability and feasibility of a single intravenous infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at 12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA) who have received methotrexate +/- other DMARDs for at least 6 months prior to screening and who have had an incomplete response to at least one TNF-alpha inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females ages 18-80 years old
* Active rheumatoid arthritis (RA) disease as per 2010 ACR/EULAR classification criteria for the diagnosis of RA.
* Must be positive for rheumatoid factor and/or anti-cyclic citrullinated peptide (anti-CCP3) but without extra-articular disease or functional limitation
* Patient with active RA defined as:

  * ≥ 4 tender joint count (TJC) 28 joint count at screening and
  * ≥ 4 swollen joint count (SJC) count 28 joint count at screening
  * ESR ≥ 28 mm/hr or hsCRP \>2.0 mg/L
* Patient has been taking MTX for at least 4 months with dose and route of administration stable for at least 8 weeks prior to screening
* Patient has had an inadequate response to at least one TNFα inhibitor with last dose at least 6 weeks prior to screening
* Use of oral DMARD (sulfasalazine, hydroxychloroquine, chloroquine and leflunomide) is permitted but must be stable for at least 3 months prior to screening

Exclusion Criteria:

* Pregnant women or women who are breastfeeding.
* Other investigational therapy received within 8 weeks or five half-lives (whichever is longer) prior to Screening (except as in exclusion #13).
* Known or suspected alcohol or drug abuse within three years preceding Screening.
* Autoimmune disease other than RA (such as systemic lupus erythematosus (SLE), mixed connective tissue disease, scleroderma, polymyositis/dermatomyositis, vasculitis)
* History of or current inflammatory joint disease other than RA (such as tophaceous gout, reactive arthritis, psoriatic arthritis, ankylosing spondylitis or other spondyloarthropathy, Lyme disease). Patients primarily diagnosed with osteoarthritis are excluded.
* Bedridden or confined to a wheelchair or patients with \> 3 arthroplasties due to RA.
* History of diagnosed and/or treated malignancy with no evidence of recurrence in past 5 years
* Surgical procedures planned to occur during the trial (these patients may be rescreened following completion of and recovery from the surgical procedure).
* Use of TNFα inhibitor for treatment of RA at time of screening or within the 6 weeks prior to screening.
* Prior use of biologic agent for treatment of RA within 6 weeks prior to screening
Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage

The purpose of this study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary postpartum hemorrhage.

This IDE study is designed to evaluate the effectiveness and safety of the Jada System to treat primary PPH. The study is literature controlled.

Eligibility Criteria:
Inclusion Criteria:

1. Adult Female, 18 years of age or older at time of consent.
2. Able to understand and provide informed consent to participate in the study.
3. Diagnosis of PPH with suspected atony within 24 hours after vaginal or c-section delivery.
4. EBL, to be determined when investigator is ready to have Jada peel pack opened: a) vaginal delivery: 500 - 1500 ml EBL or b) c-section delivery: 1000 - 1500 ml EBL.
5. Failed first-line intervention of uterotonics and uterine massage/bimanual compression to stop bleeding. Note: Uterotonic administration may continue concomitant with and post Jada use.

Exclusion Criteria:

1. EBL \> 1500 ml, to be determined when investigator is ready to have the Jada peel pack opened.
2. Delivery at a gestational age \< 34 weeks.
3. For C-sections: Cervix \< 3 cm dilated before Jada use.
4. PPH that the investigator determines to require more aggressive treatment, including any of the following: a) hysterectomy, b) b-lynch suture, c) uterine artery embolization or ligation, d) hypogastric ligation.
5. Known uterine anomaly.
6. Ongoing intrauterine pregnancy.
7. Placenta abnormality including any of the following: a) known placenta accreta, b) retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa), c) retained placenta without easy manual removal.
8. Known uterine rupture.
9. Unresolved uterine inversion.
10. Subject has undergone intrauterine balloon therapy or uterine packing for tamponade treatment of this PPH prior to use of the Jada.
11. Current cervical cancer.
12. Current purulent infection of the vagina, cervix, uterus.
13. Diagnosis of coagulopathy.
Periarticular Injection Versus Fascia Iliaca Block for Total Knee Arthroplasty

In this study, the aim is to compare the efficacy of Periarticular multimodal drug injection(group PI) and Fascia Iliaca Compartment Block ( group FI)for total knee arthroplasty.

Total knee arthroplasty is very painful surgical intervention.Patients were assigned to 2 groups to receive either periarticular multimodal drug injection or fascia iliaca compartment block for postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing knee arthroplasty
* \> 18 years of age

Exclusion Criteria:

* obesity
* heart failure
* kidney failure
* liver failure
Single Center Post Approval Proximal Humerus Fixation With the Conventus Cage PH™ Device

The Conventus CAGE™ PH (PH Cage) System Post-Approval Observational Data Collection Study (Study) is a single center, prospective, post-approval clinical study designed to collect device and procedure experience in everyday clinical practice.

The study is a prospective, non-randomized, post-market approval data collection study that is designed to collect device/procedure and outcome data on patients who have experienced proximal humerus bone fractures and received a PH Cage.

Specifically, the study will provide:

1. Patient outcome and performance data for the implant and implant procedure that that may be used to support scientific publications.
2. Assurance of continued product safety and effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be of at least legal age of consent according to applicable State Law.
* Patient is able to understand and provide written consent

Exclusion Criteria:

* The PH Cage should not be implanted in patients with suspected or known allergies to titanium or nickel.
* Pregnant female patients.
* Patients with current or history of mental illness and/or senility.
* Patients with current or history of alcoholism and/or chemical substance abuse.
* Patient has a medical condition(s) that preclude cooperation with the rehabilitation regimen.
* Patient has active infection at the operative site or other active systemic infection.
* Patient has a pathologic proximal humerus fracture.
* Patients proximal humerus fracture extends into the diaphysis.
* Patient has associated glenohumeral dislocation.
* Patient has known pre-existing rotator cuff disease.
* Patient has ipsilateral injury or concomitant surgery that will have a material impact on the study, such that the injury/surgery affects the patients' health status or the function of the injured extremity.
Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma

The purpose of this study is to determine the efficacy and the safety profile and toxicity of a combination of Velcade™ (bortezomib) with a standard chemotherapy regimen (ACVBP \[doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone\]) in the treatment of previously untreated patients with peripheral T-cell lymphoma (PTCL).

This is a multicentric, open-label, non-randomized, non-competitive clinical study, evaluating the efficacy and safety of V-ACVBP chemotherapy in previously untreated patients aged from 18 to 65 years with peripheral T-lymphoma.

It is anticipated that 60 subjects will be enrolled over two years (from June 2005 to May 2007).

The duration of the treatment period is approximately 28 weeks and patients are followed until death.

The total duration of the study is expected to be 5 years (from June 2005 to May 2010).

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated non-cutaneous peripheral T-cell lymphoma, including human T-cell lymphotropic virus type 1 (HTLV-1) related T-cell lymphoma, and natural killer (NK)-cell lymphoma.
* Ages 18 to 65 years.
* Life expectancy \> 3 months.
* Written informed consent.

Exclusion Criteria:

* B-cell lymphoma or other subtype of T-cell lymphoma including anaplastic large cell lymphoma AKL(+), lymphoblastic lymphoma and primary cutaneous T-cell lymphoma.
* Any previous therapy for lymphoma except for short-term corticosteroids before inclusion.
* Inability to tolerate the ACVBP regimen according to investigator's judgement.
* Positive serology for HIV.
* Poor renal function (creatinin \> 150 µmol/l within 14 days before enrollment), poor liver function (total bilirubin \> 30 µmol/l, transaminases \> 2.5 upper normal limit \[UNL\] within 14 days before enrollment), unless these abnormalities are related to the lymphoma.
* Poor bone marrow reserve as defined by neutrophils \< 1.5 G/l or platelets \< 100 G/l within 14 days before enrollment, unless these abnormalities are related to the lymphoma.
* Patient with \>= grade 2 peripheral neuropathy non-related to lymphoma.
* Any central nervous system (CNS) disease.
* CNS or meningeal involvement by the lymphoma.
* Any serious active disease or comorbidity according to the investigator's decision.
* Any history of cancer during the last 5 years with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma.
* Known hypersensitivity to bortezomib, boron or mannitol.
* Contraindication to any cytotoxic drug contained in chemotherapy regimen.
* Pregnant or lactating women or women of childbearing potential not willing to use an adequate method of birth control (i.e. hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of study.
* Men not agreeing to take adequate contraceptive precautions during the study.
* Treatment with investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
* Adult patient under tutelage.
The Effect of Nordic Exercise on Children's Agility

The aim of this research is to investigate the effect of one-way and two-way Nordic exercise on the agility of active children. Children who meet the necessary criteria will be randomly assigned to one-way Nordic exercise group, two-way Nordic exercise group and control group by drawing lots. Volunteers in the training group will participate in a four-week training, two sessions per week. Agility will be assessed at baseline and after four weeks with the T-agility test. In-group and between-group comparisons will be analyzed using the Statistical Package for the Social Sciences program and appropriate tests.


Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 8-12
* To be actively participating in football training.

Exclusion Criteria:

* Those with orthopedic, neurological and congenital problems.
* Those with any systematic disease.
* Those who have experience taping before.
* Those who have undergone any surgery within the last 1 year.
* Those who have been absent from training for more than 2 weeks in the last three months.
Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction

The purpose of this study is to evaluate the return of sensation in the breast(s) following breast mastectomy with and without reconstruction. Four different sensations: touch, vibration, superficial pain, and temperature will be evaluated. In addition, we will look at factors that may contribute to the return of breast sensations.

This study entitled "The Quantification of Breast Sensations Following Postmastectomy Breast Reconstruction" will evaluate the recovery of sensation in the reconstructed as well as in the nonreconstructed breast. Touch, vibration, pain and temperature sensation will be objectively evaluated greater than 1 year following completion of reconstruction. Breast sensation following immediate, tissue expander/implant breast reconstruction will be compared with that following immediate, autogenous tissue reconstruction.

A formal sensory examination will be performed. SemmesWeinstein monofilaments will evaluate touchpressure sensation in the breast. A Bioesthesiometer will determine the recovery of vibratory sensation. Temperature sensation will be evaluated by application of warm and cool stimuli. Superficial pain sensation will be evaluated by application of sharp and dull stimuli.

A patient reported assessment of sensory changes in the breast will be administered to patients. The Breast Sensation Assessment Scale © is designed to measure the prevalence, severity, and distress of 18 different sensory symptoms following breast surgery. A "Patient Demographic and Treatment Information Form" and patients' medical records will be used to obtain demographic and treatment data. The role of confounding variables (including: patient age, breast volume, axillary procedures performed and adjuvant therapies received) on the recovery of sensation will be evaluated.

The estimated accrual time for this study is 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone mastectomy
* Patients who have undergone immediate, twostage expander/implant breast reconstruction
* Patients who have undergone immediate, autogenous tissue flap reconstruction including: pedicled and/or free TRAM flap or DIEP flap reconstruction
* Patients at least 21 years of age
* Patients at least 1 year from the time of mastectomy or completion of immediate, postmastectomy reconstruction

Exclusion Criteria:

Patients who have had any of the following:

* delayed reconstruction (no reconstruction immediately after mastectomy)
* combined autogenous tissue/implant breast reconstruction
* tissue expander
* Patients who have a history of complex regional pain syndrome
* implant explantation (device is removed prematurely due to complications)
Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Adrenalectomy

This prospective, randomized ,control study aims to compare the analgesic effect,quality of recovery, length of hospital stay ,et al. between single-injection QLB(quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo laparoscopic adrenalectomy
* Informed consent

Exclusion Criteria:

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Enhanced Function and Quality of Life Following 5 Months of Exercise Therapy for Patients With Rotator Cuff Tears

This study aims to evaluate the effect of 5 months of exercise therapy for patients with irreparable rotator cuff tears.

All included patients will receive exercise therapy consisting of two exercises focusing on strengthening m. deltoideus anterior and m. teres minor.

Eligibility Criteria:
Inclusion Criteria:

* symptoms of rotator cuff rupture for at least three months with rupture of minimum musculus supraspinatus and musculus infraspinatus visualized by ultrasonography or arthroscopy
* no neurological conditions which could affect muscle strength or activity
* able to read and understand Danish
* both patients with and without a history of shoulder trauma were included

Exclusion Criteria:

* former rotator cuff surgery
* history of shoulder fracture or inflammatory conditions in the shoulder
* significant osteoarthritic changes on antero-posterior and/or lateral (outlet view) radiographs
Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis

The purpose of this study is to asses the efficacy of a 4 week low-intensity resistance training program with concurrent application of partial blood flow restriction (PBFR) to the exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in women at risk for developing symptomatic knee osteoarthritis. The primary outcome will be change in isotonic double leg-press 1 repetition maximum (1RM) strength. The investigators will test the following hypotheses. In comparison with low-intensity resistance training without use of PBFR, a four-week low-intensity resistance-training program with PBFR will:

Primary Hypothesis: Increase (a) double leg-press 1RM strength and (b) isokinetic knee extensor strength

Secondary Hypotheses:

1. Increase quadriceps muscle volume assessed by MRI
2. Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed stair climb
3. Not adversely effect knee pain or quality of life assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 45-65
* BMI greater than or equal to 25 kg/m2, or a history of a knee joint injury or surgery, or knee symptoms (pain, aching, or stiffness) on most of the last 30 days, or knee osteoarthritis

Exclusion Criteria:

* Resistance training at any time in the last 3 months prior to study
* Bilateral knee replacement
* Lower limb amputation
* Lower limb surgery in the last 6 months that affects walking ability or ability to exercise
* Back, hip or knee problems that affect walking ability or ability to exercise
* Unable to walk without a cane or walker
* Inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or polymyalgia rheumatica
* Multiple sclerosis
* Known neuropathy
* Self-report of Diabetes
* Currently being treated for cancer or having untreated cancer
* Terminal illness (cannot be cured or adequately treated and there is a reasonable expectation of death in the near future)
* Peripheral Vascular Disease
* History of myocardial infarction or stroke in the last year
* History of deep venous thrombosis
* Chest pain during exercise or at rest
* Use of supplemental oxygen
* Inability to follow protocol (e.g. lack of ability to attend visits or understand instructions)
* Staff concern for subject health (such as history of dizziness/faintness or current restrictions on activity)
* Concurrent study participation (such as the MOST study)
* Unable to attend more than 2 days within any 1 week or unable to attend 4 or more sessions during the study