cyrilzakka/clinical-trials huggingface dataset:
Cognitive Functional Therapy for Chronic Low Back Pain

There is evidence, of a single randomized controlled trial, that CFT is better than combined manual therapy and motor control exercise for chronic low back pain. However, this study had significant methodological shortcomings regarding the failure to carry out the intention to treat analysis and a considerable loss of follow-up of patients. It is important to replicate this study through a randomized clinical trial with similar objectives in another domain, but correcting these methodological shortcomings. Therefore, the aim of the study is to assess the efficacy of Cognitive Functional Therapy in patients with chronic non specific low back pain.

One hundred and forty eight patients with chronic low back pain from two outpatient physiotherapy clinics in Brazil will be randomized to receive either Cognitive Functional Therapy or combined Manual Therapy and Motor Control Exercises. Intervention: 4-10 sessions of CFT. Control: 4-10 sessions of combined Manual Therapy and Motor Control Exercises. Measurements: Clinical outcomes will be assessed at the baseline, 3 months, 6 months and 12 months after randomization. Analysis: Intention-to-treat analysis will be performed, and linear mixed models will be calculated to evaluate the effect of the intervention. Non-specific predictors, moderators and mediators of outcome will also be analysed. Discussion: This study will investigate whether the results of the first CFT clinical trial can be replicated. In addition, the results will contribute to a better understanding of the efficacy of the CFT approach.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years
* Low back pain for more than 3 months
* Disability score of 14% or more on the Oswestry Disability Index (ODI)
* Being able to walk independently with or without support
* Understand Portuguese well enough to be able to fill in the questionnaires

Exclusion Criteria:

* Main pain area is not the lumbar spine (from T12 to buttocks)
* Main pain as leg pain (eg: nerve root compression or herniated disc with radicular pain / radiculopathy, lateral and central stenosis)
* Less than 6 months after lumbar spine, lower limb or abdomen surgery
* Invasive procedures for pain relief (ex: epidural injection, rhizotomy) in the last 3 months
* Pregnancy
* Inflammatory/rheumatological diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, Scheuermann's disease)
Establishment of Human Lung Stem Cell Proliferation System and Organoid Construction in COPD

The goal of this study is to proliferate human lung stem cell in vitro in order to establish a lung organoid derived from patients with COPD. The main question it aims to answer are:

* Can human lung stem cell proliferate in vitro.
* Can a lung organoid derived from patients with COPD be established. Participants will be sampled during pulmonary bronchoscope for organoid establishment.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age under 55, regardless of gender
* 2. Patients with COPD lung disease who are going to undergo bronchoscopic biopsy
* 3. No genetic diseases and other respiratory diseases

Exclusion Criteria:

* Other conditions determined by the investigators to be unsuitable for inclusion, such as difficult sampling, difficult follow-up, and complicated with other serious diseases
Implantable Phakic Lens (IPCL) VS Implantable Collamer Lens

Phakic intraocular lenses (pIOL) of different designs and materials have been used effectively instead of corneal refractive surgery in certain situations. The pIOL exhibits a number of advantages over corneal techniques as it is suitable for high myopes, with lower production of aberrations, and superior contrast sensitivity. Keeping the accommodation is its definite lead over refractive lens exchange. The Visian implantable collamer lens (ICL; Staar Surgical, Monrovia, CA), a posterior chamber pIOL, has been stated to be useful for the correction of high myopia. Nevertheless, as an intraocular procedure, it is associated with a risk of complications as probable injury to anterior segment, retinal detachment and endophthalmitis.

The Implantable Phakic Contact Lens (IPCL V2, Caregroup Sight Solutions, India) has been developed as an alternative for the ICL, at a noticeable financial advantage. Furthermore, the highestmyopic correction which is instantly accessible with ICL is -18.0 D. Meanwhile, IPCL can provide correction higher degrees up to -30.0 D.

Former researches have been made to assess the safety and efficiency of ICL implantation, to evaluate various devices for anterior segment imaging postoperatively and to identify changes in anterior segment after surgery. A recent study determined the safety of the IPCL over a minimum follow-up period of one year. In this work the investigators aimed to compare the refractive results and the adverse effects of the IPCL and the ICL in treatment of myopia in adults.


Eligibility Criteria:
Inclusion Criteria:

* myopia of more than 6 diopter
* central anterior chamber depth more than 2.8 mm

Exclusion Criteria:

* unstable refraction
* any other ocular disease
* any systemic disease
The Effects of The Use of Baby Mobile Accompanied With Brahms Lullaby On The Infants During Sternum Dressing

The study was conducted experimentally in a randomized controlled manner in order to determine the effect of the use of baby mobile accompanied by Brahms Lullaby on physiological parameters and pain level during sternum dressing in babies. The research was carried out with 76 babies followed up in the Pediatric Cardiovascular Surgery Intensive Care Unit between August 2020 and February 2021 (Baby Mobile Group accompanied by Brahms Lullaby: 38, Control Group: 38). Data were collected by using the "Baby Monitoring Form" and "FLACC Pain Scale".


Eligibility Criteria:
Inclusion Criteria:

* Being 1-12 months
* Being volunteer for research
* Operated for Congenital Heart Disease
* Got Sternum incision
* No other chronic illness
* No similar surgical experiment before
* No visual impairment
* No hearing impairment
* No mental or neurological impairment
* Hospitalization experience

Exclusion Criteria:

-
HMF Preterm Case Studies

Nutritional requirements in preterm infants can be elevated, as a result of complex clinical circumstances including infections, immaturity of the gastrointestinal tract and invasive treatments, such as surgery which can place a greater metabolic demand on the body. Furthermore, these circumstances can impact an infant's ability to meet nutritional requirements and achieve optimum growth through normal feeding alone. Most preterm infants may need specialist care by the neonatal team during hospital admission and post-discharge, which includes enteral nutritional support.

Human Milk Fortifier (HMF) have become a component of the routine clinical care of preterm infants on neonatal units. There is published evidence to support this practice as being safe and effective. A multitude of trials have demonstrated improvements in weight, length and head circumference following interventions using HMF, compared to non-supplemented cohorts, and benefits have been observed at long term follow up.

Whilst HMF is used routinely in neonatal units, there is little clinical evidence for using them beyond discharge in the community, although this is widely accepted in practice. Nutricia have developed a new HMF (NHMF) that can be provided for use in the community.

This series of case-studies will evaluate the tolerance, compliance, acceptability and safety of the NHMF, in 15 preterm infants. Each case study will last at least 28 days, including at least 7 days in the community setting. The case studies will be conducted across multiple specialist neonatal centres in the UK, to meet the UK ACBS requirements.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants fed own mother's milk (or donor human milk) requiring HMF (as decided by the investigator)
* Born before 37 weeks completed gestational age and \>1 dropped centile since birth requiring HMF (as decided by the investigator)
* Tolerating adequate volume of enteral nutrition
* Expected to require HMF after discharge (minimum 4.0g NHMF per day at discharge)
* Written or electronic informed consent from parent/caregiver

Exclusion Criteria:

* Anticipated short term use of HMF leading to discontinuation of HMF after hospital discharge
* Presence of any relevant proven or suspected chromosomal anomaly or genetic syndrome, any gastrointestinal malformation/compromise, including Necrotising enterocolitis (NEC) (defined as Bell's stage two or higher), metabolic disorder, or congenital central nervous system malformation that may impact tolerance of enteral feeding
* Failure to establish enteral nutrition and requiring full parenteral nutrition
* Participation in other studies within 1 month prior to the entry of this study
* Known allergy to any of the study product ingredients, including cow's milk, fish and egg
* Concern or issues around the breast milk supply from mother of preterm infant at enrolment
* Investigator concerns around willingness/ability of the parent/caregiver to comply with protocol requirements and/or handle and store NHMF appropriately
Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer

Investigators assessed the effectiveness of Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting

Adjuvant chemotherapy is still the standard of care for stage Ⅲ gastric cancer. Till now, oxaliplatin with capecitabine or S1 still the standard chemotherapy regimen. Howerver, the prognosis of diffuse type gastric cancer patients is still poor even after adjuvant chemotherapy of XELOX or S1 regimen. Several retrospective, single institutional studies have shown that the addition of Nab-paclitaxel to S1 can prolong the survival of advanced gastric cancer with diffuse type.However, the effection of Nab-paclitaxel and S1 is unknown in diffuse gastric cancer patients after radical surgery. We assessed the effectiveness of radical surgery following docetaxel, nab-pacitaxel and S1 therapy for gastric cancer with diffuse type.

Eligibility Criteria:
Inclusion Criteria:

* gastric cancer patients after radical resection
* diffuse type gastric cancer stage III

Exclusion Criteria:

* Patients who have metastasis disease
* Patients who can not tolerate chemotherapy
Thermic Effect of Feeding in Cystic Fibrosis

The investigators propose to assess the contributions of the thermic effect of food intake (TEF), which is the amount of energy expended to digest food, to overall energy expenditure in Cystic Fibrosis (CF).

Total energy expenditure (TEE) is comprised of the following components: resting energy expenditure (REE), thermic effect of food intake (TEF), adaptive thermogenesis (AT). The thermic effect of food is the amount of energy expended to digest food, and can be affected by factors such as protein / fat / carbohydrate contents of meals or the amount of time over which a meal is consumed. The investigators propose to assess the contributions of the thermic effect of food intake (TEF), which is the amount of energy expended to digest food, to overall energy expenditure in CF. Participants will be assigned to either a high fat liquid meal or a high protein liquid meal and assessed for components of energy expenditure in the whole room indirect calorimeter (metabolic chamber); participants will then be crossed over to the alternate liquid meal type, and differences in resting and total energy expenditure and the thermic effect of food will be assessed between the two types of meals.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of cystic fibrosis by Cystic Fibrosis Foundation-established criteria
* being followed at the VCU (Virginia Commonwealth University) Adult Cystic Fibrosis Center
* pulmonary and overall health status at baseline as assessed by pulmonary function testing and screening labs (complete blood count, liver enzymes, cholesterol, HgA1c). Criteria for baseline status are established for each individual patient as part of routine CF pulmonary care.
* ability to understand the study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

* experiencing any signs or symptoms consistent with a pulmonary exacerbation (a decline in pulmonary function testing from baseline, recorded as part of routine CF care)
* undergoing treatment for a pulmonary exacerbation with a change in antibiotics or steroids from their baseline medications
* tobacco users
* pregnancy
Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures

Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body height. However, limited prospective data exists in the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon kyphoplasty.


Eligibility Criteria:
Inclusion Criteria:

* Males or females older than 50 years of age with acute vertebral compression fractures causing significant pain and functional limitations in their daily activities.

Exclusion Criteria:

* primary tumors of bone or evidence of metastasis at the index vertebrae
* pre-existing chronic pain or functional disability unrelated to a vertebral compression fracture which would confound the data analysis
* fracture secondary to a traumatic event
* inability to fully visualize both pedicles of the fractured vertebrae on intraoperative fluoroscopy
Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

RATIONALE: Dextromethorphan may help relieve fatigue in patients with cancer.

PURPOSE: This clinical trial is studying how well dextromethorphan works in treating patients with fatigue caused by cancer.

OBJECTIVES:

Primary

* Assess the effects of dextromethorphan hydrobromide in patients with cancer-related fatigue.

Secondary

* Correlate the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate.

OUTLINE: This is a multicenter, open-label, pilot study.

Patients receive oral dextromethorphan hydrobromide 3 times a day on days 1-7. Treatment repeats weekly for up to 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of malignancy

  * Must be undergoing active treatment for malignancy which may include hormonal therapy (e.g., tamoxifen citrate or leuprolide acetate), but not radiotherapy alone
* Fatigue score ≥ 4 on a verbal analogue scale of 0 to 10
* No untreated cancer-related anemia

PATIENT CHARACTERISTICS:

* Hemoglobin \> 10 g/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to swallow pills
* No known allergy to dextromethorphan hydrobromide
* No patients known to be phenotypically poor metabolizers of CYP2D6
* No untreated hypothyroidism

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Prior single-dose inhibitors (e.g., ranitidine or cimetidine) for hypersensitivity prophylaxis allowed
* Erythropoietic growth factor therapy of \> 8 weeks duration allowed
* No concurrent CYP2D6 inducers or inhibitors
* No concurrent monoamine oxidase inhibitors
* No other concurrent medications containing dextromethorphan hydrobromide
* No concurrent over-the-counter medication, herbal product, vitamin, food supplement, or any other type of special product unless permission to continue use is obtained from the Principal Investigator
* No other concurrent anticancer investigational agents or therapies
The Effect of a Computer-Assisted Rehabilitation Program on Epilepsy Patient

The aim of this study is to examine the effects of the RehaCom Computer-Assisted Rehabilitation Program Applied to Epilepsy Patients on Self-Management, Cognitive Function and Quality of Life.

Modules designed to train cognitive abilities will be used under the supervision of a licensed researcher who is licensed to use the RehaCom application, which is a computer-assisted cognitive rehabilitation program. Researchers can select some modules based on each patient's specific deficits, meaning that deficits can be targeted and specifically trained. Since the program will respond to the patient's specific needs, the activity may become easier or more difficult depending on the patient's performance. Epilepsy patients will be encouraged by researchers during the exercises and will be able to give feedback on progress at the end of the session. After determining the appropriate time and day for each patient in the experimental group, the intervention will continue for 6 weeks with 45-minute sessions once a week.

Eligibility Criteria:
Inclusion Criteria:

* Being registered at Selçuk University Faculty of Medicine Hospital Neurology Polyclinic
* Having been diagnosed with epilepsy for at least 6 months
* Being between the ages of 18 and 60 (60 is the age limit for the Moxo test)
* Volunteer to provide transportation to Selçuk University Faculty of Medicine for research one day a week.
* Ability to use tools such as computer mouse and telephone
* Score 24 or more from the Mini Mental State Test

Exclusion Criteria:

* Individuals have physical, mental, visual and hearing disabilities
* Having another neurological disorder
* The individual has a transportation disability
Metabolomics and Genetic Diagnosing Pancreatic Neuroendocrine Tumors in MEN1 Patients

Objectives:

The aim of the present study is to assess the significance of metabolomics and genetics in diagnosing and survival evaluation for pNET in the periodic follow-up of MEN1 patients.

Aim 1: To evaluate the relationship of serum global metabolic profiles with subsequent development of aggressive PNET and evaluate patients survival in a nested case-control study of MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have developed non-aggressive PNETs (controls).

Aim 2: Validate the top serum metabolites identified from Aim 1 in MEN1 patients who have developed aggressive PNETs and MEN1 patients who have developed non-aggressive PNETs, using a targeted metabolomics approach.

Aim 3: Prospectively identify the potential miRNA biomarkers of serum with miRNA sequencing in MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have developed non-aggressive PNETs (controls).

Aim 4: Validate the potential miRNA biomarkers identified from Aim 1 in MEN1 patients who have developed aggressive PNETs and in MEN1 patients who have developed non-aggressive PNETs, using a targeted qRT-PCR approach (in serums), as well as to see the relationship of potential miRNA biomarkers with patients survival.


Eligibility Criteria:
Inclusion Criteria:

1. The study will include all patients with a confirmed MEN1 diagnosis (clinical, genetic or familial criteria).
2. No prior history of PNET.

Exclusion Criteria:

N/A
Asian Multicenter Prospective Study of ctDNA Sequencing

This study is a genetic analysis of aberrations in circulating tumor DNA (ctDNA) in patients in Asian countries. This study protocol is divided into parts describing several subanalyses that differ in terms of cancer types, analytical methods, participating countries, and participating institutions.

NGS analysis will be performed on cfDNA extracted from peripheral blood samples of target patients to determine the types and incidences of genetic abnormalities. Patient information and gene abnormality data will be integrated, and the types and incidences of gene abnormalities by cancer type will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 years or older at registration.
2. Diagnosis of cancer which is targeted by each cohort.
3. Metastatic and/or recurrent disease.

Exclusion Criteria:

1. Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the esophagus, stomach, colon, or cervix.
2. Ongoing chemotherapy. (Chemotherapy-naïve patients or awaiting initiation of the next line of chemotherapy are eligible. There is no limit on the number of prior chemotherapies or on the time from completion of chemotherapy to registration).
3. Ongoing radiation therapy. (There are no limits on the time from completion of radiation therapy to registration).
Sympathetic and Parasympathetic Responses to Specific Chiropractic Adjustments

A study to determine if a chiropractic adjustment in the cervical spine will effect the parasympathetics and a chiropractic adjustment in the thoracic spine will effect the sympathetics.


Eligibility Criteria:
Inclusion Criteria:

* age 25-55, asymptomatic

Exclusion Criteria:

* HBP, heart condition
Effect of Pentoxifylline and Zinc Co-administration in Patients With Oligoasthenoteratozoospermia

The aim of this study is to investigate the impact of co-administration of Pentoxifylline and Zinc sulfate on oxidative stress, apoptosis, and inflammation, sperm capacitation and parameters in infertile men.

This study will be performed as a double-blind randomized clinical trial on idiopathic infertile men (including oligoasthenosospermia, dyspnea, astheno-teratozoospermia, oligo-astheno-teratozoospermia) referred to Shafa Infertility Clinic. Patient satisfaction, non-use of contraceptives, men aged 25 to 43 years and idiopathic infertility according to WHO criteria (World Health, 2010) are our study criteria. A food questionnaire is also taken from them to identify patients. Any medication that may affect sperm production should be discontinued within three months of the study.

Sampling and administration of pentoxifylline and zinc:

Preparation and analysis of semen samples are performed according to WHO 2010 recommendations. Semen samples are prepared by masturbating after a 3 to 5 day abstinence period. Two semen samples from these men, one before and the other after the intervention, are evaluated for basic parameters. For liquefaction, semen samples are incubated for 30 to 60 minutes at 37 ° C. Microscopic tests are performed to evaluate indicators such as sperm concentration in semen, motility and sperm morphology. Objectives and study methods are explained to patients who meet the inclusion criteria. Written consent is then obtained from the candidate. Body mass index (BMI) is assessed for patients. Also, at the beginning of the study, 5 cc of blood is taken from patients to measure reproductive hormones.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic infertile men
* have had at least one year of unprotected intercourse infertility
* Sperm parameters abnormality

Exclusion Criteria:

* Men with varicocele
* Hypersensitivity to pentoxifylline \& zinc,
* pelvic organic pathologies
* congenital adrenal hyperplasia
* thyroid dysfunction
* Cushing's syndrome
* hyper prolactinemia
* androgen secreting neoplasia
* diabetes mellitus
* consumption of medications affecting carbohydrate metabolism
* severe hepatic
* pancreatitis
* kidney diseases
* gallbladder diseases
* Patients with alcohol consumption
* Patients who use cigarettes and drugs