cyrilzakka/clinical-trials huggingface dataset:
Expressive Writing in Male Infertility

The purpose of this study is to determine whether expressive writing can be effective in improving the well-being and sperm quality in patients with male infertility.

Expressive writing is a therapeutic intervention designed by the psychologist James W. Pennebaker. Individuals write on three days for about 20 minutes about particularly stressful experiences in their life. Several studies showed that expressive writing can have beneficial effects on the frequency of health care utilization and well-being. Particularly in patients with rheumatism, kidney cancer and posttraumatic stress disorder expressive writing showed an positive effect on subjective well-being. Furthermore, in several studies expressive writing showed a positive effect on immune parameters.

As many studies suggest an important negative effect of stress on well-being and sperm parameters in male infertility, we want to investigate the effect of expressive writing in male infertility.The expressive writing condition is compared to a non emotional writing condition, in which individuals write about mainly non emotional topics such as time management. In this randomized-controlled trial subjects were allocated sequentially by block wise randomization (block size of 4). For randomization a computer generated random list was used. The allocation was concealed in a series of numbered sealed envelopes. The envelope was opened immediately before the first writing session.

Eligibility Criteria:
Inclusion Criteria:

* Male infertile patients with a pathological spermiogram according to WHO criteria

Exclusion Criteria:

* Drugs affecting sperm quality
* Patients with chromosomal anomalies affecting sperm quality (e.g. Klinefelter- Syndrome)
* Severe Psychiatric disorder defined as psychotic disorder (schizophrenia, bipolar disorder) or substance-related disorder
* Patients currently in psychotherapeutic or psychiatric therapy
Efficacy of High-intensity Laser Therapy (HILT) in the Patients With Cervical Disc Herniation

The worldwide prevalence of neck pain is between 16.7-75.1%, it has been seen at an increasing rate in recent years due to sedentary living conditions.

Pharmacological treatment, neck collar, traction, manual therapy, interventional injection techniques, surgical treatment and conventional physical therapy methods such as hotpack, ultrasound, TENS (Transcutaneous electrical nerve stimulation), vacuum interference, exercise are applied in the treatment of neck pain.

In recent years, High Intensity Laser Therapy (HILT) has been used as a painless and non-invasive physical therapy agent. It received FDA approval in 2002 for HILT in the treatment of variety of musculoskeletal disorders.

There are a few studies in the literature investigating the efficacy of HILT in chronic neck pain. There is only one study investigating the efficacy of HILT in cervical disc herniation. In this study, the efficacy of HILT and ultrasound-TENS in the treatment of neck pain caused by cervical disc herniation has been compared, but the results of the exercise control group and long-term follow-up were not available.

The aim of this randomized controlled trial is to evaluate the short and long-term efficacy of HILT treatment using improvement in the pain, range of motion, activities of daily living and functionality of the cervical spine in patients with cervical disc herniation. In group 1, only exercises will be applied; in the group 2, HILT will be applied in addition to exercise; in the group 3, hotpack, TENS, ultrasound will be applied in addition to exercises.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cervical disc herniation diagnosed by MRI whose symptoms started for at least 3 months ago
* Not receiving physical therapy and rehabilitation in the last 3 months
* Not taking any medications such as analgesics, anti-inflammatoires or muscle relaxants for the treatment of symptoms.

Exclusion Criteria:

* patients with major psychiatric disease, cervical spine surgery and rheumatological disease; pacemaker users; those who were injected with local corticosteroids; pregnant women; cancer patients
Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer

The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1 radical hysterectomy in cervical cancer.

The primary objective of this study is to evaluate the rate of postvoid residual urine volume (PVR) \<50ml on postoperative day 4 in patients with stage IB1 and IIA1 cervix cancer underwent complete nerve-sparing type C1 radical hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years to \<= 70 years.
* Women with histologically confirmed, primary adenocarcinoma or squamous cell carcinoma of the uterine cervix.
* Stage IIA1, or IB1 disease.
* Karnofsky performance status \>70.
* Patients who comply with follow-up.
* With written informed consent.

Exclusion Criteria:

* Age\>70
* History of lower urinary tract damage or surgery.
* With abnormal urodynamic study results.
* Karnofsky performance status \<70.
* Patients who have uncontrolled psychological disorders.
* Unwilling to or unable to comply with protocol.
* Prior treatment with pelvic radiotherapy
Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Elderly People With Chronic Bronchitis and COPD

Evaluation of immunogenicity and safety of the subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease recruited to receive the schedule of two doses inactivated COVID-19 vaccine with the interval of 21 days .

The subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease were recruited to receive the schedule of two doses inactivated COVID-19 vaccine with the interval of 21 days .

Blood samples will be collected 2 times: before the 1st dose of vaccinatioin and 28 days after the 2nd dose of vaccination.

Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.

Eligibility Criteria:
Inclusion criteria:

* Subjects aged 60 and above with full capacity for civil conduct;
* Chronic bronchitis (or chronic obstructive pulmonary disease) diagnosed by a medical institution at level I or above;
* Body temperature \< 37.3 ° C confirmed by clinical examination before enrollment ;
* Able and willing to complete the entire study plan during the study follow-up period;
* Have the ability to understand the study procedures, voluntarily sign informed consent, and comply with the requirements of the clinical study protocol

Exclusion criteria for the first dose:

* Subjects were previously confirmed cases of COVID-19 or asymptomatic infected persons;
* Subjects have history of vaccination against COVID-19;
* Being allergic to any component of vaccines (including excipients) ;
* Injection of non-specific immunoglobulin within 1 month before enrollment;
* Injection of live attenuated vaccines within 1 month and injection of other vaccines within 14 days before enrollment;
* Subjects who have experienced severe allergic reactions to vaccines (e.g. acute anaphylaxis, urticaria, angioneurotic edema, dyspnea, etc.);
* Having uncontrolled epilepsy and other progressive neurological disorders and a history of Guillain-Barre syndrome;
* Having severe liver and kidney diseases, malignant tumors, acute diseases or acute episodes of chronic diseases;
* Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukaemia or other autoimmune diseases;
* Have been diagnosed with thrombocytopenia or other clotting disorders that may contraindicate subcutaneous injection;
* During an acute episode of chronic bronchitis/chronic obstructive pulmonary disease;
* Other subjects whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.

Exclusion criteria for the second dose:

* Subjects who had vaccine-related adverse reactions after the first dose;
* Having high fever (axillary temperature ≥39.0℃) for three days after the first dose of inoculation, or severe allergic reaction;
* Having any adverse nervous system reaction after the first dose;
* During the acute onset of a chronic disease, or the recovery of acute complications less than two weeks;
* Other reasons for exclusion considered by the investigator.
Improving Surgical Outcomes With Early PT After ACDF

The goal of this two-group randomized clinical trial is to examine the effects of early postoperative PT compared to delayed postoperative PT for improving outcomes after hospital discharge for ACDF surgery.

The main question this clinical trial aims to answer are:

* Whether early PT participants will demonstrate greater improvements in outcomes compared to delayed PT participants.
* Whether improvements in handgrip strength, cervical endurance, and cervical range of motion will be associated with improvements in outcomes.

Participants will be randomized to one of two groups (early PT or delayed PT) and outcomes compared across groups.

This study is a prospective randomized controlled trial of early PT (within 3 months after surgery) versus delayed PT (greater than 3 months after surgery) in adults following ACDF surgery for degenerative conditions. The central hypothesis is that an early PT program will be effective in improving disability, pain, physical function, opioid use and return to work/duty. 76 participants will be enrolled and randomized (38 patients per randomized group), with 64 (85%) expected to be retained in the trial at the 12-month follow-up. Eligible patients undergoing ACDF surgery for a degenerative condition will be randomized to one of two groups (early PT or delayed PT). Patients will be enrolled prior to surgery, asked to complete a preoperative questionnaire prior to surgery and then randomized. Patients randomized to one of the PT groups will have their first PT visit scheduled for them by study staff prior to surgery. This visit will occur at approximately 2 weeks after hospital discharge for the early PT group and approximately 3 months after hospital discharge for the delayed PT group. All randomized patients will be asked to participate in follow-up visits approximately 3-, 6- and 12-months after hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Surgical treatment of a cervical degenerative condition using a 1- or 2-level ACDF procedure;
* English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and
* Age 18-75 years of age (individuals older than 75 are more likely to experience respiratory and nervous system complications and death following ACDF)

Exclusion Criteria:

* Surgery secondary to trauma, fracture, tumor, infection, or spinal deformity;
* Undergoing cervical corpectomy;
* Prior history of cervical spine surgery in last 5 years;
* Diagnosis or presence of osteoporosis;
* Diagnosis or presence of severe psychiatric disorder such as schizophrenia or bipolar disorder;
* Documented history of alcohol and/or drug abuse;
* Currently involved in litigation due to injury;
* Currently undergoing treatment for cancer;
* Patients not able to return for follow-up visits due to time and travel limitation or other reasons; and
* Unable to provide a stable telephone or physical address
Multisensory Environment Room in Children With Autism Spectrum Disorder

To investigate the effect of multisensory environment room on behavior in children with autism spectrum disorder age 3-5 years old. The children will be randomized into 2 groups: the experimental and the control group. The control group will be educated about the autistic and hoe program training. The intervention group will got the same educational program as the control group plus training in multisensory room environment once a week for 10 weeks. The outcome measurement was done as the before intervention, at the 5th and 10th week.

This project is a pilot study.

Eligibility Criteria:
Inclusion Criteria:

* the children who was diagnosed with autism according to DSM-5
* age 3-5 years old
* has the severity mild-to-moderate and severe according to childhood autism rating scale, 2nd edition

Exclusion Criteria:

* The guardians deny to enroll into the study.
* blindness, deafness
* got the treatment of r-TMS less than 1 year
Validation, Reliability and Pilot Test of the Personalized Exercise Questionnaire (PEQ)

The PEQ is the first tool to measure facilitators, barriers, and preferences to exercise in people with osteoporosis.

Osteoporosis is a disease of the bones characterized by low bone mass and microarchitectural deterioration of bone tissue. This disease can increase the risk of bone fragility fractures and is indirectly associated with premature death. These fractures are more common than cancer or heart disease in North American women 50 years or older, with an osteoporotic fracture occurring every 3 seconds worldwide, and are a major issue to patients and the healthcare system. Increased fracture rates, particularly in the hip and spine, may lead to hospitalization and subsequent immobility.

Some studies have shown fitness to be a better predictor of bone mineral density than age, yet adherence to exercise is poor. Studies suggest that 50% of those registered in an exercise program drop out within the first 6 months, lack of time being the number one barrier in many populations. To increase adherence to an exercise program, a systematic review has identified a number of facilitators and barriers to exercise in adults with osteoporosis and osteopenia.

Hitherto, no measurement tool has been created to measure these facilitators and barriers in people with osteoporosis. The investigators have developed and validated the PEQ (Personalized Exercise Questionnaire), a new tool that can measure the facilitators, barriers, and preferences to exercise. The next steps are to test the reliability, known-group validity, and pilot test this tool in the osteoporosis population.

Future physical activity or exercise interventions could benefit from using this tool to leveraging the facilitators and limiting the barriers to exercise to increase adherence to an exercise program.

Eligibility Criteria:
Inclusion Criteria:

1. The participant is able and willing to provide informed consent
2. The participant is male or female, 18+
3. The participant has received a diagnosis, from a physician, of primary osteopenia or osteoporosis (T \< - 1.0)
4. The participant can read and write English

Exclusion Criteria:

1. The participant has been diagnosed with secondary osteopenia or osteoporosis
2. The participant has a history of smoking, alcoholism, gastrointestinal disease, hypercalciuria and/or steroid use.
3. The participant is diagnosed with a reading disability or dyslexia
4. The participant has a cognitive impairment of some severity as to adversely affect the validity of the data
A Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism

The purpose of this study is to show that a magnetic field applied to the front part of the brain of children suffering from Autism Spectrum Disorder(ASD) can improve function and ameliorate symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Autism Spectrum Disorder by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) rendered by the examination and sufficient Childhood Autism Rating Scale 2nd Edition (CARS-2) score to qualify as autism.
* CARS-2 score between 36 and 47 inclusively
* Age between 4 and 12 years (at day of informed consent)
* Child must suffer disrupted sleep patterns defined as a minimum of 3 nights per week of delayed onset of sleep or night-time awakenings. If these are medicated with mild sedatives or melatonin and corrected, the requirement for medication or melatonin will qualify as evidence of a sleep disorder.

Exclusion Criteria:

* Diagnosis of Asperger's Disorder, Pervasive Developmental Disorder Not Otherwise specified
* History of clinically significant traumatic brain injury
* Any condition associated with increased intracranial pressure
* Cerebral Aneurysm
* Down's Syndrome or other chromosomal abnormality
* EEG abnormalities that indicate seizure risk
* Intracranial implant
* Unstable medical condition not otherwise specified
* Clinically significant organic disease unrelated to autism
Oxygen Saturation Alarms in the Neonatal Intensive Care Unit

Infants will be observed in the neonatal intensive care unit for 4 hours. The observer will note the timing of oxygen saturation alarms, staff response, and interrupted staff activities.

False alarms may be particularly prevalent in the neonatal intensive care unit (NICU) where uncontrolled motion of infants can intensify the problem. The performance of pulse oximeters is of particular importance in the NICU because of the danger that both hyperoxemia and hypoxemia pose to newborns; hyperoxemia can lead to chronic lung disease or retinopathy of prematurity, and hypoxemia depresses spontaneous ventilation. High false alarm rates contribute to the problem of noise in the NICU. They also have the potential to endanger patients if clinicians become inured to the continual alarms and ignore some that may be clinically relevant. There have been few studies on the utility of pulse oximeter alarms in the NICU, particularly with the new-generation technology. This study will build on the small body of existing literature on alarm rates in new-generation pulse oximeters in neonates and provide details about the relationship of the alarms to clinical interventions.

This is an observational study of 50 infants at three hospitals in the United States. The observer will be an experienced nurse with comprehensive training to ensure consistency. The infants and clinical staff will be observed for four hours continuously. Observers will note the timing of alarms, response, interrupted clinical staff activities, and any clinical interventions, and timing of interventions. Clinical staff will also be questioned on whether the alarm was consistent with a desaturation event. Infant characteristics may affect the frequency of alarms. Data collected will include age, gender, weight, ethnicity, diagnosis, and medications.

This study will evaluate the proportion of nuisance alarms relative to the proportion of clinically relevant alarms. It will also evaluate the differences in alarm frequencies across infant characteristics and characterize nurse activities interrupted by the alarms.

Eligibility Criteria:
Inclusion Criteria:

* Infants in the NICU continuously monitored by pulse oximetry

Exclusion Criteria:

* Infants whose legal guardians do not consent
Effectiveness of Exergaming in Adittion to Conventional Treatment for Physical Therapy in People with Multiple Sclerosis

The present study aims to evaluate the effectiveness of two different exergaming systems in addition to conventional treatment on physical functional capacity, balance, muscle strength, spasticity in lower limbs and quality of life compared to an isolated conventional intervention in patients with multiple sclerosis. The secondary aim will be to compare the differences between both exergaming groups.

Multiple sclerosis is a chronic autoimmune inflammatory disease of the central nervous system, which produces demyelination and axonal damage in the brain and spinal cord. Since there is currently no treatment for this condition, the goal of rehabilitation is to assist people with their manifestations. Over the last decade, exergaming with commercial consoles has demonstrated potential benefits in managing motor and functional impairments. However, new videogame strategies and assessment in randomized controlled trials are necessary to obtain significant results in different outcomes.

The hypothesis is that the exergaming systems in addition to conventional treatment will show statistically significant improvements on motor skills, spasticity, and quality of life results compared to conventional therapy alone. Therefore, this project aims to evaluate the effectiveness of two different exergaming systems in addition to conventional treatment on physical functional capacity, balance, muscle strength, spasticity in lower limbs and quality of life compared to an isolated conventional intervention in patients with multiple sclerosis. The investigators here design a multi-center, assessor-blind, 24-weeks, randomized controlled trial protocol. The achievement of the present project would serve to analyze the benefits of an alternative exercise program in the motor and functional rehabilitation program of multiple sclerosis patients and to identify the subjects in whom the benefits would be greater and whose implementation would have greater priority.

Eligibility Criteria:
Inclusion Criteria:

(i) Diagnosis of MS in any of its types (clinically isolated syndrome, relapsing-remitting MS, primary progressive MS or secondary progressive MS) based on the McDonald criteria.

(ii) Age over 18 years.

(iii) Mini-Mental State Examination score \> 19 points.

(iv) Score on the Expanded Disability Status Scale (EDSS) under 7.0 points.

Exclusion Criteria:

(i) Diagnosis of another disease that affects balance and/or coordination.

(ii) Exacerbation or steroid treatment in the 30 days prior to inclusion in the study.

(iii) Presence of visual deficits.
Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial

Irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in western studies. Different with westerns, squamous carcinoma is the main pathological type in china patients. The investigators then initiated a prospective phase II clinical trial with irinotecan/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.


Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age 18 to 70 years old
* Histologically confirmed esophageal squamous carcinoma, no prior palliative chemotherapy; recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of irinotecan as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy
* Unresectable recurrent or metastatic disease
* Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
* Karnofsky performance status ≥70
* Life expectancy of ≥3 month
* No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
* ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
* Serum AKP \< 2.5 times ULN (within 7 days before enrollment)
* Serum creatinine \<1.0 times ULN (within 7 days before enrollment)
* Bilirubin level \< 1.0 times ULN (within 7 days before enrollment)
* WBC\>4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl(within 7 days before enrollment)
* No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃；
* Good compliance

Exclusion Criteria:

* previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy
* Known hypersensitivity to irinotecan
* Only with Brain or bone metastasis
* Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
* No measurable lesions, eg. pleural fluid and ascites
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
* Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months or
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Chronic diarrhea
* Mentally abnormal or disable cognition,including CNS metastasis