cyrilzakka/clinical-trials huggingface dataset:
Acupuncture for People Experiencing Period Loss Due to Chemotherapy

The purpose of this study is to find out whether it is practical (feasible) to use acupuncture to treat period loss (amenorrhea) caused by chemotherapy treatment in people with cancer. The researchers will look at how many participants enroll and complete the study. The researchers will also study how treatment with acupuncture affects the amount of time for the menstrual cycle to return and symptoms and quality of life related to amenorrhea.


Eligibility Criteria:
Inclusion Criteria:

* English speaking women under the age of 40, with a history of stage I, II, or III cancer at the age of 18-39
* Premenopausal status with regular menstruation at the time of diagnosis by patient report
* Completed chemotherapy within the past year
* Report cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment.
* Have been without menses for at least 3 months following the completion of chemotherapy
* Willing to adhere to all study-related procedures, including randomization to one of the two possible arms: acupuncture and WLC

Exclusion Criteria:

* Metastatic cancer (stage IV)
* Had been pregnant or lactating within 3 months prior to enrollment
* History of hysterectomy or oophorectomy
* Ongoing or planned radiation or surgery within 4 months from randomization
* Use of acupuncture for menses recovery within 3 months of enrollment
* Had been or will be receiving ovarian suppression medicine, such as leuprolide (Lupron) and goserelin (Zoladex), or hormonal contraception drugs within 3 months of enrollment or during the study period
A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients. Estudo PROICA

The purpose of this study is to evaluate the feasibility, safety and effects in inflammatory response of the therapy with a probiotic agent, the yeast Saccharomyces boulardii (SB), in chronic heart failure patients.

A cardiointestinal syndrome has been described in heart failure patients, with morphologic and functional intestinal disorders, increased enteropathogenic bacteria concentration, bacterial translocation and inflammatory activation, thus contributing for clinical worsening and progression of the disease.

In clinical practice, probiotics has been used in several different conditions, as inflammatory bowel diseases, acute and antibiotic-associated diarrhea, food allergies, and cancer, showing benefits in inflammation and reducing bacterial translocation. However, the use of probiotics in heart failure has never been described.

Eligibility Criteria:
Inclusion Criteria:

* Class I or II (NYHA)heart failure patients

Exclusion Criteria:

* Corticosteroid use within 30 days
* NSAID use within 30 days
* Antibiotic use within 30 days
* Acute infections
* Inflammatory diseases
* Autoimmune diseases
* Cancer
* Intestinal diseases
* Chronic renal failure
PANDA Gym: Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability

Early childhood detection of motor delays or impairments provides the opportunity for early treatment which improves health outcomes. This study will use state of the art sensors combined with machine learning algorithms to develop objective, accurate, easy-to-use tools for the early scoring of deficits and lays the foundation for the early prediction of physical disability.

For children with neurodevelopmental disabilities, early treatment in the first year of life improves long-term outcomes. However, the investigators are currently held back by inadequacies of available clinical tests to measure and predict impairment. Existing tests are hard to administer, require specialized training, and have limited long-term predictive value. There is a critical need to develop an objective, accurate, easy-to-use tool for the early prediction of long-term physical disability. The field of pediatrics and infant development would greatly benefit from a quantitative score that would correlate with existing clinical measures used today to detect movement impairments in very young infants. To realize a new generation of tests that will be easy to administer, the investigators will obtain large datasets of infants playing in an instrumented gym or simply being recorded while moving in a supine posture. Video and sensor data analyses will convert movement into feature vectors based on our knowledge of the problem domain. Our approach will use machine learning to relate these feature vectors to currently recommended clinical tests or other ground truth information. The power of this design is that algorithms can utilize many aspects of movement to produce the relevant scores.

Eligibility Criteria:
Infants, male and female, between 0-6 months (Infants older than 6 months before initial enrollment will be excluded).

* Infants with early brain injury (EBI):

  * Hydrocephalus
  * Hypoxic-ischemic encephalopathy (HIE)
  * Periventricular leukomalacia (PVL)
  * Intraventricular hemorrhage (IVH)
  * Stroke
* Healthy infants (controls):

  o No history of early brain injury (EBI)
* Infants without EBI/risk for future disability:

  * Infants without known brain injuries, but with a history of preterm birth less than 32-week gestation with significant medical problems, difficulty eating, or who lack head control at 4 months of age or later will be classified as moderate risk.
The Risk of Falling in Patients with Chronic Obstructive Pulmonary Disease

This cross-sectional study aims to investigate what daily activities increase the risk of falling in Chronic Obstructive Pulmonary Disease patients (COPD).

To investigate the what daily activities increase the risk of falling in patients with COPD, twenty-eight voluntary patients with COPD, aged between 35-80 years will be divided into two groups: Group-1 have at least one fall (fallers) and Group-2 have no history of falls (non-fallers). Fall frequency will be investigated by asking patients to report any fall event in the last one month and the last 12-months. Assessments will be performed at baseline. Fear of falling will be assessed with Activities-Specific Balance Confidence (ABC) scale. Balance will be evaluated by Berg Balance Scale (BBS). The level of dyspnea during daily activities will be assessed with London Chest Activity of Daily Living (LCADL) scale. The global impacts of COPD symptoms on overall health status will be evaluated by The COPD Assessment Test (CAT). The Modified Medical Research Council Dyspnea (MMRC) scale and Six-Minute Walking Test (6MWT) will be used for evaluating the how dyspnea limits the patients' daily activities and functional capacity, respectively. Isometric muscle strength will be measured with a handheld dynamometer of quadriceps femoris. Pulmonary function data will be retrieved from the last 1-month clinical records of the COPD patients. Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 21.0. Among the groups, demographic and clinical variables will be compared with independent sample t-test for continuous variables and a chi-square test for categorical variables. The significance level will be set as p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

1. stable disease (no severe exacerbations in the prior 3 months)
2. ability to walk independently
3. ability to read and write in Turkish
4. able to follow simple instructions
5. no pathology in visual ability and hearing

Exclusion Criteria:

1. a history of specific balance problems (i.e., diagnosed vestibular or neurological disorder)
2. severe musculoskeletal, neurological or cardiovascular disorders that limit mobility
3. use of medication(s) that may increase the risk of falls
4. participate in pulmonary rehabilitation in the lasts six months
A Study of Nasopharyngeal Carcinoma From Guangdong

This prospective cohort study aims to establish prognostic models, to discover toxicity associated predictors and to validate randomized trials in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* histological confirmed nasopharyngeal carcinoma;
* scanned by magnetic resonance imaging from calvaria vertex to clavicles before treatment;
* pretreatment Epstein-Barr virus deoxyribonucleic acid copy number is available;
* irradiated with intensity-modulated radiotherapy;

Exclusion Criteria:

* finishing anticancer therapy in two or more hospitals;
* pregnancy or lactation;
* diagnosed with other sort of cancer before or during the treatment.
Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

The aim of this clinical trial is to evaluate the efficacy of tesamorelin as a therapy for peripheral nerve injuries. The investigators hypothesize that treatment with tesamorelin will result in faster and more substantial recovery of motor and sensory function following surgical repair of injured peripheral nerves. Patients with upper extremity nerve injuries will be randomly assigned to receive either tesamorelin treatment or no treatment. Assessments for nerve regeneration, muscle function, and sensation will be conducted every three months for a total of 12 months. Outcomes in patients receiving tesamorelin will be compared to those in the untreated group to determine the effectiveness of tesamorelin as a therapeutic intervention for nerve injuries.

This is a randomized, double-blinded, clinical trial assessing the efficacy of tesamorelin as a therapy to improve functional recovery following peripheral nerve injury. Tesamorelin is a drug that stimulates increased production of growth hormone, and growth hormone has been shown to improve nerve regeneration and functional recovery in animal studies.

A total of 36 participants with repaired ulnar nerve lacerations will be enrolled, of which 18 will be randomly assigned to receive the study drug and 18 will receive no treatment. To minimize bias, outcome assessors and the biostatistician analyzing the data will be blinded to the treatment assignments. Following enrollment, each participant will have 12 monthly follow-up visits during which participants will undergo testing to assess recovery. Outcome assessments will include clinical exams, electrodiagnostic studies and questionnaires.

The total duration of the study is expected to be 4 years.

Eligibility Criteria:
Inclusion Criteria:

* Ulnar nerve laceration at the wrist, repaired primarily

Exclusion Criteria:

* Certain cancers (active or in the past)
* Uncontrolled diabetes or hypertension
* Certain pituitary problems
* Oral contraceptives
* Pregnancy
* Drug or alcohol dependence
* Psychosocial issues that would limit participation and compliance
Exhaled Breath Condensate (EBC) Assessment in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

This study aimed to assess airway inflammation in patients during the course of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) by serial analyses of their exhaled breath condensates (EBC).

Subject recruitment

Patients who had been admitted to the Prince of Wales Hospital with AECOPD were recruited for this study. Subjects with pneumonic changes on the chest radiographs were excluded. Age and sex-matched COPD subjects at stable state (without AECOPD for at least 10 weeks) and healthy, non-smoking subjects were recruited as controls.

Collection of exhaled breath condensate (EBC) EBC was collected using the EcoScreen (VIASYS Healthcare, Conshohochen, PA, USA) according to the manufacturer's instructions. EBC was stored in 250 microL aliquots immediately at -70oC until analysis. EBC was collected on Day 5, 14, 30 and 60 after hospitalization for subjects with AECOPD. For the stable COPD patients and normal controls, EBC collection was performed once.

Measurement of TNF alpha, LTB4 and IL-8 The concentrations of TNF alpha, LTB4, and IL-8 in EBC were measured in one batch by high-sensitivity sandwich enzyme immunoassays (TNF alpha and IL-8 from BioSource International, Camarillo, CA, USA; LTB4 from Cayman Chemical Company, Ann Arbor, MI, USA) according to the manufacturers' instructions. Intra-subject repeatability of TNF alpha, LTB4 and IL-8 was assessed by collection of EBC in stable COPD subjects. EBC was collected as described above at the same time (09:00 to 10:00) on 2 consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had been admitted to the Prince of Wales Hospital with AECOPD were recruited for this study. AECOPD was defined when a patient with background COPD according to the GOLD guideline presented with at least two of the following major symptoms (increased dyspnoea, increased sputum purulence, increased sputum volume) or one major and one minor symptom (nasal discharge/congestion, wheeze, sore throat, cough) for at least two consecutive days.
* Age and sex-matched COPD subjects at stable state (without AECOPD for at least 10 weeks) and healthy, non-smoking subjects were recruited as controls. Current smokers (defined as cigarette smoking in the last 6 months) were excluded from this study.

Exclusion Criteria:

* Subjects with pneumonic changes on the chest radiographs were excluded.
* Current smokers (defined as cigarette smoking in the last 6 months) were excluded from this study.
Nasal Intermittent Positive Pressure Ventilation(NIPPV) vs Continuous Positive Airway Pressure for Respiratory Distress Syndrome

In the past, several studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.The purpose of the present study was to compare NIPPV with NCPAP on the need for endotracheal ventilation and subsequent complications

To this day, early use of noninvasive respiratory support strategies has been suggested to be the most effective pathway to reduce those risks. Nasal continuous positive airway pressure (NCPAP) and nasal intermittent positive pressure ventilation (NIPPV) are two widely used ways of noninvasive ventilation strategies in preterm infant. As compared with invasive ventilation, NCPAP reduces the risks abnormal neurodevelopment. However, there is only 60% success rate of avoiding intubation in the preterm neonate supported with NCPAP. Supplying with an intermittent peak pressure on NCPAP, NIPPV is considered as a strengthened version of NCPAP with increased flow delivery in the upper airway, increased minute volume and functional residual capacity and recruitment of collapsed alveoli, improved stability of the chest wall and reduced asynchrony of thoraco-abdominal movement,which have been proven to be crucial to decrease the incidences of invasive ventilation and death. However, studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age (GA) is from 26 to 37 weeks;
* Diagnosis of RDS. The diagnosis of respiratory distress syndrome(RDS) will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
* RDS Silverman score\>5;
* Informed parental consent has been obtained.

Exclusion Criteria:

* Severe RDS requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation;
* Major congenital malformations or complex congenital heart disease;
* Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
* Cardiopulmonary arrest needing prolonged resuscitation;
* Transferred out of the neonatal intensive care unit without treatment.
Visual Acuity After the Combined Binocular Implantation of +2.5 Diopters and +3.0 Diopters ReSTOR Multifocal Intraocular Lenses.

The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.5 D and +3.0 D apodized diffractive multifocal intraocular lenses.

Bifocal multifocal intraocular lenses (MIOL) are effective in achieving good uncorrected visual acuities in the distance and the near. However, the intermediate vision is of increasing relevance for everyday's life. Several multifocal intraocular lenses have been developed to improvement intermediate vision. Nonetheless, those systems still possess adverse photic effects and do not garantuee spectacle independence. Therefore, the combination of a lower-addition bifocal intraocular lense in the distance-dominant eye with a higher-addition bifocal intraocular lense in the fellow-eye might be a promising approach to address these drawbacks of current binocular and trifocal intraocular lenses.

Eligibility Criteria:
Inclusion Criteria:

* clinically significant cataract
* endothelial cell count: patients aged 18-75 years: \> 1000 cells/mm2; patients \> 75 years: \> 750 cells/mm2
* absence of vision-limiting corneal or retinal comorbidities
* capability to understand the informed consent

Exclusion Criteria:

* expected postoperative astigmatism \> 0.75 diopters
* irregular astigmatism
* dilated pupil diameter \< 3 mm
* corneal and fundus abnormalities that might cause visual impairments
* inability to attend follow-up visits
Lifespan Integration After Sexual Trauma

A new psychological trauma treatment method is tested on a population (n 100) of adult women who have been sexually traumatized at one specific time 0-5 years before they enter the study.

One treatment session is given with the psychological treatment method Lifespan Integration (LI). The main outcome is change on Impact of Event Scale (IES) before and after the treatment. The change is analyzed and compared with the change on Impact of Event Scale (IES) among the people on the waiting list arm. Self-rating questionnaires are being used 5+/-3 days before treatment, 20 +/-3 days after treatment, and 6 months +/- 6 weeks after the first measurement.

Eligibility Criteria:
Inclusion Criteria:

* Sexual trauma 1-5 years before inclusion
* understanding Swedish, read and spoken

Exclusion Criteria:

* Psychotic symptoms
* drug abuse
* neuropsychiatric diagnoses ADHD and asperger
The Efficacy and Safety of Bortezomib Combined With Fludarabine and Cytarabine Treatment for Mantle Cell Lymphoma

Mantle cell lymphoma (MCL) is a type of non-Hodgkin's lymphoma (NHL) and shows poor survival. This study to evaluate the efficacy and safety of Bortezomib combined with Fludarabine and Cytarabine treatment in the naive and relapsed MCL who are not eligible for high dose therapy and transplantation.

The eligibility criteria were pathologically confirmed, previously untreated MCL or relapsed MCL as defined by the World Health Organization classification; age≥18 years; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; adequate haematologic function (haemoglobin \> 9.0 g/l, absolute neutrophil count \> 1500/ml, platelets \> 75,000/l), hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal), renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); normal coagulation function and electrocardiogram results. Stage was defined according to the Ann Arbor system.

The Fujian Medical University Union Hospital approved this study before subjects were enrolled.

Treatment dosages were as follows:

days 1,4,8,and 11 subcutaneous infusion of 1.3mg/m2 Bortezomib. Days 1-3 intravenous infusion 25mg/m2 Fludarabine. Days 1-3 intravenous infusion of 500mg/m2 Cytarabine. The regimen was repeated every 28 days for a maximum of six cycles.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

1. pathologically confirmed, previously untreated MCL or relapsed MCL as defined by the World Health Organization classification;
2. age≥18 years;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
4. adequate haematologic function (haemoglobin \> 9.0 g/l, absolute neutrophil count \> 1500/ml, platelets \> 75,000/l),
5. adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal),
6. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min);
7. normal coagulation function and electrocardiogram results.
8. willingness to provide written informed consent.

Exclusion Criteria:

1. MCL patients who do NOT response or are refractory to preview treatment.
2. Who do NOT sign the consent form.
3. whose life expectation is less than 6 months.
Perfusion Index and Labor Analgesia

It can be suggested that sympathetic tonus increase and pain, caused by the removal of the effect of epidural analgesia applied at birth, may also affect perfüsion index. The purpose of this study is; To correlate the VAS value at the time of return of epidural analgesia with the PI values at that time and, to test the possibility of using PI variants as an objective tool for predicting pain initiation time and assessing pain.


Eligibility Criteria:
Inclusion Criteria:

* women who will give normal spontaneous vaginal delivery
* Between the ages of 18-45

Exclusion Criteria:

* Patients who do not accept the procedure,
* those under 18 years of age - over 45 years,
* those with low platelet counts,
* those with infection at the puncture site,
* those with progressive neurological disease,
* Those with increased intracranial pressure,
* those with hypovolemia
Evaluation of a Modern System to Allow for Growth in Children With Scoliosis Versus a Conventional Treatment

The foremost challenge when managing early onset scoliosis (curve deformity before the age of 10) is to prevent curve progression while maintaining growth of the spine. Current treatment options require repetitive interventions as the spine and the child grow. This study will compare two techniques of growth modulation: Standard dual growing rods versus the new Luqué Trolley screws

Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer re-operations after 3 years of follow-up (FU) than patients included in the comparison group

The purpose of this clinical study is to show that the growth guiding construct with DePuy Synthes TROLLEY Gliding Vehicles allows for less re-operations and for ongoing spinal growth across an instrumented immature spine while preventing curve progression in early onset scoliosis patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 5 - 10 years
* Diagnosis of Early Onset Scoliosis with any of the following etiologies:

Idiopathic Congenital Neuromuscular Syndromic Mesenchymal

- Significant growth potential defined by any of the following: pre peek growth velocity bone age \< 10; open triradiate cartilage

* An expected significant spinal deformity of more than 80 degrees at skeletal maturity
* Signed informed consent as legally required (patient, parents, etc.)
* Willingness and ability of the patient to participate in the clinical investigation including imaging and FU procedures
* Willingness and ability of the parents to support the patient in his/her study participation
* Ability of the patient and parents to understand the content of the patient information / informed consent form and participate in the clinical investigation
* Signed informed consent by patient / parent(s)

Exclusion Criteria:

* Curve magnitude and rigidity: Cobb greater than 100 degrees or bends less than 50 degrees
* Prior spinal surgery
* Skeletal maturity
* Any not medically managed severe systemic disease
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study