cyrilzakka/clinical-trials huggingface dataset:
Validity and Reliability of the 6 Minute Pegboard Ring Test

This study aimed to investigate the validity and reliability of 6PBRT in individuals with DMD and its applicability on these patients.

Duchenne muscular dystrophy (DMD) is the most common type of progressive muscular dystrophies and is an X-linked recessive, rarely autosomal dominant, muscle disease. DMD begins in childhood and progresses until they become unable to walk. Individuals with DMD experience skeletal muscle weakness, difficulty breathing, and decreased exercise capacity. In these patients, traditionally lower extremity tests are; 6-minute walk tests, treadmill tests and Cardiopulmonary exercise tests are used. However, it is reported that the upper extremity is also affected in individuals with DMD. The 6-Minute Pegboard and Ring Test (6PBRT), which is valid and reliable in most disease groups, is also a test that can be applied to the upper extremities. It is important to use 6PBRT frequently in clinical research practice for patients with DMD and to know its validity and reliability. To our knowledge, the validity and reliability of this test in individuals with DMD has not been established in the literature. This study aimed to investigate the validity and reliability of 6PBRT in individuals with DMD and its applicability on these patients.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research,
* Being diagnosed with Duchenne muscular dystrophy between the ages of 6-17,
* Being Level 1 and 2 according to the Brooke Upper Extremity Functional Classification Scale
* Having no problems reading and/or understanding the scales and cooperating with the tests to be.
* Ability to sit independently for approximately 15 minutes during the evaluation

Exclusion Criteria:

* Not volunteering to participate in the research,
* Having any orthopedic problem in the upper extremity,
* A neurological disease or other clinical condition that may affect cognitive status having a diagnosis,
* Having had surgery on the upper extremities in the last 6 months and any having an injury
* At a level that prevents functional activities in the upper extremity Having severe contractures (joint restriction)
Cabergoline and Coasting to Prevent OHSS

The effectiveness of cabergoline to prevent moderate-severe OHSS to coasting.

To randomly compare three study groups under a high risk of developing OHSS to one of three arms of management, either coasting for 1 to 3 days or receiving cabergoline for 8 days or coasting for 1 day plus receiving cabergoline for 8 days in ICSI patients following the long luteal GnRH agonist protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Age \<or= 35, BMI \<or= 30
2. Long protocol GnRH agonist cycles
3. Estradiol level on day of HCG \>or= 3500 pg/ml
4. Retrieving more than 15 oocytes

Exclusion Criteria:

1. Male factor
2. Uterine factor
Effect of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Diseases (BARBHER)

Investigators will compare the incidence of incisional hernia in women who underwent midline laparotomy whose abdominal fascia was closed with barbed suture vs. conventional non-barbed suture.


Eligibility Criteria:
Inclusion Criteria:

* Anticipating midline laparotomy for gynecologic diseases
* ECOG performance status 0 - 2

Exclusion Criteria:

* Previous or current abdominal incisional hernia
* Pregnant
* Previous radiation on abdomen area
* Allergy to PDS or irgacare MP
* Having disease affecting wound healing such as uncontrolled DM, autoimmune vasculitis, liver cirrhosis, coagulopathy
* BMI \> 35
* Current or anticipated use of drugs affecting wound healing such as bevacizumab (with 4 week drug free period, bevacizumab user is eligible)
* Abdominal midline laparotomy within 6 months
* Surgery for infection control
A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

The co-primary objectives of the study are to:

* Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).
* Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
* History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency (with or without topical calcineurin inhibitors \[TCI\]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
* EASI score ≥16
* vIGA-AD score ≥3
* ≥10% body surface area (BSA) of AD involvement
* Worst pruritus numerical rating scale ≥ 4

Exclusion Criteria:

* Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
* Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:

  * Systemic corticosteroids
  * Systemic immunosuppressants
  * Phototherapy
  * Oral or topical Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

  * TCS of any potency
  * TCI
  * Topical phosphodiesterase type 4 (PDE4) inhibitors
  * Other topical immunosuppressive agents
  * Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents
Learned Resourcefulness Intervention

This study aimed to test the effects of a learned resourcefulness interveniton program on the learned resourcefulness, caregiver burden, quality of life for older family caregivers.

A quasi-experimental trail will be used to test the effects of a learned resourcefulness intervention program on the learned resourcefulness, caregiver burden, quality of life for older family caregivers. Through the use of convenience sampling strategy, one teaching medical hospital with approximately 104 older family caregivers in southern Taiwan will be recruited and simple randomly assigned based on teaching medical hospital to a Learned resourcefulness intervention program experimental group or a wait-list control group. Participants in the experimental group will receive the learned resourcefulness intervention program led by researcher, one time per week, 50 minutes for one week, 10 minutes for these weeks; participants in the wait-list control group will continue to receive their home care service. One pre-test and two post-tests, all participants will assessed for learned resourcefulness, caregiver burden, quality of life at baseline, and at 5 and 9 weeks of the study.

Eligibility Criteria:
Inclusion Criteria:

* aged 60 and above
* family caregivers of disabled adults who received home care service
* cognitively intact as assessed by SPMSQ score of 8 and above
* disabled adults will assessed by Barthel Index score of 60 and bellow
* able to answer questions

Exclusion Criteria:

* participants with severe mental disabilities
Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients

Rectal cancer is a frequent but curable malignancy in the Western world. The golden standard in treating these patients consists of neoadjuvant chemoradiotherapy (CRT) followed by extensive surgery regardless of tumor response. The main question is whether extensive surgery can be avoided holding in mind that already a significant amount of patients reach a pathological complete response after radiochemotherapy. The goal of this study is dual. First of all, the investigators want to investigate the value of DW-MRI and 18FDG-PET in the assessment of response after neoadjuvant CRT in 100 patients with rectal cancer, to select those patients eligible for less invasive surgery. In the same patient group, the investigators will examine the biomarker potential of molecular characteristics of the tumor in blood and tissue. Using both molecular and radiological findings, the investigators want to predict pathological response after chemoradiotherapy and to select patients who may benefit from treatment adjustments during chemoradiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age.
* Patient's body weight is ≤ 120 kg.
* Histologically proven and evaluable (according to RECIST criteria) adenocarcinoma of the rectum (tumour \<15 cm from the anal verge), staged T3-4 N0 and T1-4N1-2.
* WHO PS ≤ 2
* Adequate bone marrow, hepatic and renal function (assessed within 14 days prior to study entry):
* Hemoglobin \>10.0 g/dL,
* Absolute neutrophil count \> 1.5 x 109/L,
* Platelet count \> 100 x 109/L,
* Presence of adequate contraception in fertile patients. Adequate methods of contraception are: intra-uterine device, hormonal contraception, condom use with spermicide.
* Written informed consent must be given according to ICH/GCP and national/local regulations.

Exclusion Criteria:

* Evidence of distant metastases.
* Prior chemotherapy or radiotherapy for rectal cancer.
* Pregnant or breastfeeding women.
* Significant impairment of intestinal resorption (e.g. chronic diarrhea, inflammatory bowel disease).
* Known allergies to intravenous contrast agents.
* Contra-indications for magnetic resonance imaging (metal implants, claustrophobia, etc. ).
* Previous or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and non-melanoma skin cancer.
* History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
* Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury

This phase II/III clinical trial is designed to evaluate the safety and efficacy of autologous Mesenchymal Stem Cells (MSC) transplanted directly into the injured spinal cord.

The Principal investigator has performed a clinical trial using autologous MSCs in patients with cervical spinal cord injury. The results revealed the safety of autologous MSC. This Phase II, III single-center trial is to assess the safety and efficacy of bone marrow-derived mesenchymal stem cell transplantation direct to injured spinal cord site via laminectomy. After recovery from the operation, the subjects receive 4 weeks of physical and occupational therapy.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 16-65 years
* Traumatic spinal cord injury at the level of cervical
* American Spinal Injury Association Impairment Scale B
* 12 months or more post spinal cord injury subject with stable neurological finding after more than 1 month rehabilitation therapy
* No signs of contracture
* Good physical condition to go through operation
* Must be willing and able to participate in study procedures with no mental and verbal problem
* Able to consent by patients or legal representatives

Exclusion Criteria:

* Serum SGOT/SGPT \> 3 X upper limit of normal or Creatinine \> 1.5 X upper limit of normal
* Major surgical procedure in the past 3 months
* Penetrating injury
* Mechanical ventilation
* Serious pre-existing medical conditions
* Recently diagnosed infection (Urinary tract infection, Pneumonia etc)
* Positive skin test for penicillin
* Positive result for viral markers (human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and Venereal Disease Research Laboratory (VDRL) test)
* Pregnant women, women of childbearing potential who do not want adequate contraception, breastfeeding females
* Unwilling to participate in study
* Patients with psychiatric disorder severe as to make compliance with the treatment unlike, and signing informed consent impossible
* Drug abuse in the past 1 year
* Participating in other clinical trials in the past 1 month
* Inappropriate patients to participate in the study according to the chief investigator
Ultrasonography in Children With First Febrile Urinary Tract Infection

In recent decades, different tests have been recommended by guidelines in the management of first febrile urinary tract infection (fUTI) in children, including kidney ultrasound (KUS), cystography (VCUG) and renal scintigraphy in order to exclude underlying kidney anomalies. The majority of guidelines, continue to recommend a routine KUS for all children at the first fUTI. On the other hand, as this approach is not based on robust evidence, other guidelines suggest that KUS should only be performed on selected patients according to specific risks. Despite being a non-invasive and radiation-free method, KUS tests negative in 83% of cases of fUTIs and possesses low specificity for low grade vesico-ureteral reflux (VUR). Since VUR is the most commonly associated renal malformation with UTI, it is evident that all the guidelines focus on the research of VUR, especially in times when antenatal ultrasound allows to screen for major congenital anomalies of kidney and urinary tract (CAKUT). However, VUR-associated nephropathy appears to be related to primary dysplastic damage rather than to be secondary to the reflux itself and not preventable from antibiotic prophylaxis in terms of recurrence and of kidney scar. To reduce the number of normal VCUGs performed, recent evidence regarding VUR suggests that the presence of pathogens different from E. coli and UTI recurrence may help to identify children who necessitate further investigations. A preliminary retrospective monocentric study enrolling all patients aged 2 to 36 months diagnosed with first fUTI who subsequently underwent US evaluation of the kidneys and urinary tract, found that atypical germ and recurrence of UTI exhibits a 85% sensitivity to detect pathological ultrasound. The aim of this multicentric study is to prospectively evaluate the diagnostic accuracy of the presence of atypical germ combined with the recurrence of UTI in predicting the positivity of KUS in children aged 2 months to 3 years old with first episode of fUTI


Eligibility Criteria:
Inclusion Criteria:

- Patient with first episode of fUTI that subsequently do KUS.

Exclusion Criteria:

* patients with previous episodes of UTIs
* patients on antibiotic prophylaxis
* previous finding of malformative uropathies or cystic disease
* prenatal diagnosis of CAKUT with the following parameters: Presence of oligohydramnios, alterations in renal number, location and echo structure, bladder alteration, dilations of the renal pelvis and ureters
Cetuximab and Vemurafenib Plus FOLFIRI for BRAF V600E Mutated Advanced Colorectal Cancer (IMPROVEMENT)

This clinical trial aims to evaluate the efficacy, safety of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation.


Eligibility Criteria:
Inclusion Criteria:

* Patients have histologically or cytologically confirmed advanced or recurrent CRC;
* Patients with BRAV V600E mutation/KRAS WT based on the NGS or ARMS-PCR detection of tumor tissue;
* Patients have measurable disease as defined by RECIST 1.1 as determined by investigator;
* Patient with a history of radiotherapy at least 3 months before on the day of providing consent, but the measurable lesion should not be within the scope of radiotherapy;
* Patients without a history of receiving vemurafenib or cetuximab;
* Patients with age of 18-75yr;
* Patients with a performance status of 0,1or 2 on the Eastern Cooperative Oncology Group.；
* Patients with Life expectancy of more than 12 weeks;
* Patients must have the ability to understand and sign the written informed consent voluntarily;
* Female of childbearing potential who are negative in a pregnancy test within 14 days before enrollment. Both male and female patients should agree to use an adequate method of contraception (total abstinence, an intrauterine device or hormone releasing system, an contraceptive implant and an oral contraceptive) starting with the first dose of study therapy through 120 days after the last dose of study therapy. Duration will be determined when the subject is assigned to treatment.

Exclusion Criteria:

* Patients with KRAS/NRAS mutation;
* Patients with major surgery or severe trauma within 4 weeks before the first medication;
* Patients with hypersensitivity to the components in the study protocol;；
* Patients who are ready to give birth or are pregnant.。
* Patients with brain metastases 。
* Bone marrow, liver and kidney function did not meet the requirements of chemotherapy as follows：

  * Neutrophil count\<1,500/mm3；
  * Platelet count \<80,000/mm3；
  * Total bilirubin \>1.5-times the upper limit of normal；
  * ALT/AST\>2.5-times the upper limit of normal for patients without liver metastases; (5.0-times the upper limit of normal for patients without liver metastases)
  * Creatinine \>1.5-times the upper limit of normal；
* Patients with cancers other than advanced colorectal cancer within five years prior to the start of treatment in this study. Cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor were excluded;；
* Patients without legal capacity or limited civil capacity;
Naloxone Nasal Spray Compared With Naloxone Injection for Opioid Overdoses Outside the Hospital

This trial will compare the clinical response to intramuscular and intranasal naloxone in pre-hospital opioid overdoses. Objective of the study is to measure and evaluate clinical response (return of spontaneous respiration within 10 minutes of naloxone administration) to a new nasal naloxone formulation in real opioid overdoses in the pre-hospital environment. The aim is to demonstrate that intranasal administration of naloxone is not clinically inferior to intramuscular administration, which is now standard treatment of care.


Eligibility Criteria:
Inclusion Criteria:

* Suspected opioid overdose clinically diagnosed by emergency medical service (EMS) based on the following criteria

  1. Reduced (below and equal to 8 breaths per minute) or absent spontaneous respiration
  2. Miosis
  3. Glasgow Coma Scale (GCS) below 12
* Palpable carotid or radial arterial pulse

Exclusion Criteria:

* Cardiac arrest
* Failure to assist ventilation using mask-bag technique
* Facial trauma or epistaxis or visible nasal blockage
* Iatrogenic opioid overdose when opioid is administered in- hospital, or by EMS or other health care workers in the pre- hospital setting
* Suspected or visibly pregnant participant
* Has received naloxone by any route in the current overdose
* in prison or custody by police
* EMS staff without training as study workers
* No study drug available
* Study drug frozen as indicated by Freeze Watch in kit or past its expiry date
* Deemed unfit for inclusion due to any other cause by study personnel at the scene; such as unsafe work environment for EMS
Heterogeneity and Development of Early COPD

This study aims to investigate the clinical characteristics and heterogeneities of early chronic obstructive pulmonary disease (COPD), to determine the disease development of early COPD, and to establish a multidimensional model for predicting the outcomes of early COPD.


Eligibility Criteria:
Inclusion Criteria:

* The individuals who meet the defining criteria of PRISm, COPD Stage 0, Pre-COPD, Early COPD, Young COPD, and Mild COPD, according to the latest GOLD documents and publications.

Exclusion Criteria:

* Age \< 18 years or \> 80 years;
* Pregnant or maternal women;
* Having malignant and active tumor(s), and receiving treatment;
* Undergoing a surgical operation;
* Having problems with mental awareness;
* Having difficulties in daily activities;
* Participating in other interventional clinical trials.
Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving fludarabine together with cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide to see how well it works compared to fludarabine alone in treating patients with advanced chronic lymphocytic leukemia.

OBJECTIVES:

Primary

* Compare the progression-free survival, as well the overall survival and duration of remission in patients with previously untreated, advanced chronic lymphocytic leukemia treated with fludarabine with versus without cyclophosphamide.

Secondary

* Compare the incidence of side effects and quality of life of patients treated with these drugs.

OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms

* Arm I: Patients receive fludarabine IV on days 1-5.
* Arm II: Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Confirmed diagnosis of previously untreated chronic lymphocytic leukemia (CLL)

  * Binet stage C and stage B are acceptable if there is rapid disease progression, symptoms of enlarged lymph nodes and organs, or severe B-symptoms
  * Binet stage A is acceptable, if there are B-symptoms

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy \> 6 months
* No severe organ dysfunction
* No other previous or concurrent neoplasms, autoimmune hemolytic anemia, or thrombocytopenia

PRIOR CONCURRENT THERAPY:

* No prior or concurrent chemotherapy
Changes in Ciprofol Dosage in Insomnia Patients Undergoing Digestive Endoscopy

To compare the dosage requirement of ciprofol during digestive endoscopy between patients with insomnia and those with normal sleep pattern.

The investigators aim to investigate whether ciprofol dosage requirement is increased in patients with insomnia undergoing digestive endoscopy compared with normal sleep patterns.

Eligibility Criteria:
Inclusion Criteria:

* Patients with insomnia:

  1. Age of 18 - 64 years;
  2. ASA physical status of I - II;
  3. BMI of 15 - 30;
  4. Scheduled for digestive endoscopy under intravenous anesthesia;
  5. Positive screening results according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder;
  6. 8-item Sleep Condition Indicator (SCI; score 0-4; range 0-32, higher score means better sleep) scored 16 or less;
* Patients with normal sleep:

  1. Age of 18 - 64 years;
  2. ASA physical status of I - II;
  3. BMI of 15 - 30;
  4. Scheduled for digestive endoscopy under intravenous anesthesia;
  5. No history or evidence of insomnia.

Exclusion Criteria:

1. Associated with any neurological disease;
2. Daily alcohol consumption;
3. Any contraindication to intravenous anesthetic drug, such as hypotension or shock;
4. History of allergy to any drug used in the study;
5. Pregnancy or breastfeeding;
6. Patients with sleep apnea syndrome;
7. acute upper respiratory infection;
8. Patients with psychological diseases who report suicidal thoughts;
9. Patients who need to work or take care of children/elderly people frequently at night.