cyrilzakka/clinical-trials huggingface dataset:
Thrust Manipulation vs. Non-thrust Mobilizations for Mechanical Neck Pain

The purpose of this clinical trial is to compare the use of thrust manipulation to non-thrust mobilizations for mechanical neck pain when they are applied to both the cervical and thoracic spine. Both of these techniques have been compared in previous trials but a pragmatic approach will be employed as well as controlling for clinical equipoise.

A total sample size of 136 subjects with mechanical neck pain will be recruited to participant in this trial from multiple clinic and university sites around the country. Each subject will be evaluated by a licensed physical therapist that specializes in orthopedic manual therapy (OMT). Each treating therapist will be blinded be the data collection and each data collection therapist will be blinded to the treatment allocation. Subjects data will be collected at the initial visit, second visit, and at discharge. The maximum number of weeks that a subject may be enrolled is 8 weeks (2 months). At that point, they are discharged from the study. The treating therapist will allocate the subject through the already completed randomization procedures. Once the subject is randomized, the treating therapist will perform the OMT based on their clinical reasoning and in a manner they feel would benefit the patient the most. In addition to the OMT, each subject will receive a home exercise program, advice, encouragement, and education. A number of outcome variables will be collected regarded pain and disability as well as one physical performance measure.

Eligibility Criteria:
Inclusion Criteria:

* Chief complaint of neck pain. (Non-specific neck pain with a primary location between the superior nuchal line and the first thoracic spinous process)
* Age \>18
* A minimum Neck Disability Index (NDI) score ≥ 20%

Exclusion Criteria:

* Contraindications to OMT including; malignancy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term corticosteroid use.
* Nerve root compression diagnosed as having at least 2 of the following:

  * Upper extremity muscle weakness within a specific cervical/thoracic myotome
  * Diminished deep tendon reflexes of the biceps brachii, brachioradialis, or triceps muscle.
  * Diminished sensation to light touch or pinprick in a specific upper extremity dermatome.
* History of neck or thoracic spine surgery
* Neck pain of \<2 on the NPRS
* Currently receiving other forms of conservative care and unwilling to stop for the duration of their participation in the study.
* Any pending litigation related to their neck pain
* Therapist is unable to elicit the chief complaint with passive accessory intervertebral movements (PAIVM).
Brain Plasticity of Autism in Response to Early Behavioral Intervention: A Multimodal MRI Study

Autism is a well-recognized neurodevelopmental disorder severely affecting the health of children. While the unclear neurobiological basis of autism and the lack of effective medication, the most commonly used approach for treatment is behavioral intervention. However, the pathophysiological mechanisms underlying the intervention therapy remains incompletely understood. The current project aims to explore the impacts of different early behavioral intervention methods on brain plasticity of autism using multimodal MRI technique and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods.

Autism is a well-recognized neurodevelopmental disorder severely affecting the health of children. While the unclear neurobiological basis of autism and the lack of effective medication, the most commonly used approach for treatment is behavioral intervention. However, the pathophysiological mechanisms underlying the intervention therapy remains incompletely understood. The current project aims to explore the impacts of different early behavioral intervention methods on brain plasticity of autism using multimodal MRI technique and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods. Investigators collect participants' brain imaging data, eye movement data, stool samples and clinical scale score before and after intervention. Investigators first investigate longitudinal effect of behavioral intervention on brain structure and function in children with autism. In addition, investigators provide new biological indexes upon multimodal large-scale brain connectomes to evaluate the curative effect of intervention. Finally, investigators propose a prediction model of intervention effect based on multimodal multivariate pattern analysis methods. Furthermore, investigators expect to map the state-of-the-art biomarkers on multi-modal networks to provide a new interpretation of pathophysiological mechanisms of autism.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 2 to 8 years old.
* Clinical DSM-IV diagnosis of autism.

Exclusion Criteria:

* Subjects with other neurodevelopmental diseases.
* Subjects with contraindications to MRI.
Combination of Cryosurgey and NK Immunotherapy for Recurrent Pharyngeal Cancer

The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent pharyngeal cancer.

By enrolling patients with recurrent pharyngeal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
ADH1 and ADH2 Disease Monitoring Study (DMS)

A global, multi-center, Disease Monitoring Study (DMS) in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1) or Autosomal Dominant Hypocalcemia Type 2 (ADH2) designed to characterize ADH1 and ADH2 disease presentation and progression through retrospective (past) and longitudinal prospective (over time into the future) data collection.

The ADH1 and ADH2 DMS is designed to better understand the disease burden of ADH1 and ADH2, how participants with ADH1 or ADH2 are managed with standard of care practices in a real-world setting, and how standard of care treatment impacts ADH1 and ADH2 symptoms.

The study will include adult and pediatric participants with a confirmed clinical diagnosis of ADH1 or ADH2. Each participant's data will be collected over a period of up to 5 years. In addition, retrospective (or past) data will be collected.

Eligibility Criteria:
Key Inclusion Criteria:

* Have a documented activating variant or variant of uncertain significance of the CASR gene causative of ADH1 or documented activating variant or variant of uncertain significance of the GNA11 gene causative of ADH2 associated with a clinical syndrome of hypoparathyroidism prior to enrollment

Note: Acceptable documentation includes CASR or GNA11 genetic analysis report. If no prior documented CASR or GNA11 gene variant or variant of uncertain significance, potential participants can undergo CASR and GNA11 gene variant analysis at Screening.

* Be willing and able to provide informed consent or assent after the nature of the study and its details have been explained, and prior to any research-related procedures
* Be willing and able to provide access to prior medical records including imaging, biochemical, and diagnostic and medical history data, if available
* Be willing and able to comply with the study visit schedule and study procedures

Key Exclusion Criteria:

* Have serious medical or psychiatric comorbidity that, in the opinion of the Investigator, would present a concern for participant safety or compromise the ability to provide consent or assent, or comply with the study visit schedule and study procedures
* Enrollment in an interventional clinical study at the time of DMS Screening visit

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of Use of Brain Activity Monitoring for Evaluation of Depression Treatment

This study evaluates the use of brain activity monitoring for early identification of pharmaceutical treatment efficacy and development of depression deterioration events.

The study will be conducted in two arms:

In arm I, participants diagnosed with depression. In arm II, healthy participants.

Arm I - Participants that need to start or switch their pharmacological antidepressant therapy will be recruited. Their clinical status will be evaluated and their EEG characteristics will be collected.

Arm II - Clinical and EEG characteristics of Healthy volunteers will collected on a similar timetable.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 -70 years (Adult, Senior)
* Able and willing to comply with all study requirements.

Additional Inclusion Criteria for Arm I

* Diagnosed with depression
* Being within 2 days of receiving pharmaceutical treatment for depression for the first

time or changing dose or changing type of current pharmaceutical treatment or addition to

drug of current pharmaceutical treatment.

Additional Inclusion Criteria for Arm II

Brief Symptom Inventory (BSI \< 2.3).

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

* Diagnosed with Psychotic disorder.
* Diagnosed with Central Neurological disorder.
* A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse

or dependence.

* Hearing disorder and/or known ear drum impairment.
* High suicide risk as judged by the research team.
Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity

Infertility was reported in approximately 15% of all heterozygous couples, with male factor accounting for nearly half the cases. This typically occurs due to low sperm production, sperm dysfunction, and sperm delivery obstruction. Etiology of male infertility can be attributed to many factors including acute or chronic illness, accidents, and lifestyle choices.

This study demonstrated that using a painless, convenient at-home device could significantly improve sperm motility and count. This device can be utilized to tackle (for unexplained infertility) the significant issue of infertility in a cost-effective, safe and efficacious.

Eligibility Criteria:
Inclusion Criteria:

* Infertile male with oligosperma, necrospermia, asthenozoospermia or hypospermia. Must not taking any drugs or medications for infertility and has nit any congenital diseases in the genital tracts or chronic diseases.

Exclusion Criteria:

* Have congenial genital tract disease, has a chrome disease, has other than the above mentioned causes for infertility or taking medications that can affect the fertility.
Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation

To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5 colon segments prior to colonoscopy.

All participants enrolled to the study will be allocated to one of two arms. Patients of the experimental morning-only regimen arm will prepare and take MOVIPREP® solution in the full dose - 2 litres of MOVIPREP® preparation in the early morning on the day of the colonoscopy clinical procedure. Participants in the standard split-dose regimen arm will prepare and take MOVIPREP® solution in split doses - ½ of dose (1 litre) the evening before + ½ of dose (1 litre) of MOVIPREP® preparation in the morning of the day of the colonoscopy.

The study consists of three visits. Participation in the study lasts no more than 11 days; 3 days as minimum.

There is no follow-up period planned except in case of any adverse events (AEs) when the follow-up period will last until the participant has recovered or until all AE-related queries for the participant have been resolved.

Eligibility Criteria:
Inclusion Criteria:

* male or female ≥18 years and ≤ 85 years
* colonoscopy procedure indicated
* willing to stay in the outpatient clinical site for colonoscopy and questionnaire completion
* willing and able to undergo study-related procedures
* informed consent signed by a patient for participation in the study
* negative pregnancy test in women with childbearing potential and consent for double barrier method birth control for subjects, men and women, during the study

Exclusion Criteria:

* ileus
* suspected colonic tumor with manifestations of intestinal obstruction
* delayed gastric emptying (gastroparesis), weak vomiting reflex, tendency to aspiration and regurgitation
* toxic megacolon which is a result of severe inflammatory conditions of the colon including Crohn's disease and ulcerative colitis
* suspected intestinal perforation or risk of gastrointestinal perforation
* signs of severe intestinal bleeding
* acute inflammatory anal or perianal pathology
* severe concomitant diseases of internal organs
* psychiatric diseases in aggravation stage
* hypersensitivity to polyethylene glycol and/or any component of MOVIPREP® preparation
* phenylketonuria or diagnosed glucose-6-phosphate dehydrogenate deficiency
* unconsciousness
* dehydration
* severe inflammatory diseases
* acute abdominal pain of unknown etiology
* pregnancy and lactation period
* participation in any other clinical study (including studies of experimental devices) in 30 days prior participation in the present trial
* patients who test positive for human immunodeficiency virus (HIV)/autoimmune disease (AID), Wasserman reaction (RW) or hepatitis B virus (HBC)
* any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the participant or the quality of study data
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains

The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.

The Sabin IPV was manufactured with poliovirus type1, 2, 3 Sabin strains and Vero cells by micro-carrier culture in 550 liter bioreactors. The virus suspension was harvested ,ultra-concentrated, purified and inactivated with formalin. Three formulations A,B,C of Sabin IPV were used, the DAg contents for A were type1 45,type2 64,type3 67.5 DU /0.5ml/per dose; for B 30,32,45 DU/0.5ml/per dose; for C 15,16,22.5 DU/0.5ml/per dose.

This is a randomized, double-blind, placebo control phase 1 clinical trial. Total 130 individuals were selected ,including adults (n=20), children(n= 20) and infants(n= 90). Adults were randomized to two groups A1(n=10) and A2(n=10).Group A1 received one dose of B ,one month later group A2 received one dose of A for safety observation. Children were randomized to two groups C1(n=10) and C2(n=10) and followed the same vaccination and safety observation procedures as adults. Infants were randomly allocated to three groups I-1,I-2,I-3 for safety and immunogenicity study. Group I-1 were vaccinated with three doses of C(n=15) or placebo (n=15) on day 0,30,60,serum samples were collected before and 30 days after dose 3 for detecting neutralization antibody. The same procedures were followed by GroupI-2 for B and group I-3 for A as groupI-1 with 30 days intermission.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, age from 60 days to 60 years old;
* Routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions are normal before vaccination;
* Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
* Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
* Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
* Axillary temperature ≤37℃.

Exclusion Criteria:

* Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
* Abnormal results of routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions before vaccination;
* Low platelet or bleeding disorder do not allow vaccination into the muscle;
* Have damaged or lower immunological function;
* Received blood, plasma or immunoglobulin treatment since birth;
* Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome ).
Exploration of the Pleural Cavity Using a fleXible endoscoPe

EXPLORE is a first-in-human study of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.

Thoracoscopy is usually performed either with rigid thoracoscopes, or with flexible bronchoscopes. The latter is less invasive and less expensive, but flexible bronchoscopes are difficult to manipulate within the pleural cavity and do not provide an adequate orientation within the pleural space. It is therefore associated with a lower diagnostic yield than thoracoscopy with rigid thoracoscopes. On the other hand, rigid thoracoscopes are associated with more pain, a higher cost, and usually require one-lung ventilation. Gastro-intestinal endoscopes allow a better orientation than bronchoscopes in cavities, and have wider operative channels. The EXPLORE study investigates the feasibility and safety of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pleural effusion affirmed by chest radiography,
* Indication thoracoscopy, asked by the pulmonologist or thoracic surgeon for diagnostic investigation and / or pleural symphysis
* Inpatient or outpatient,
* Women of childbearing age having an effective contraceptive coverage (combined oral contraceptives or intrauterine device or tubal ligation); a negative pregnancy test should be obtained,
* For postmenopausal women, menopause confirmation of diagnosis,

Exclusion Criteria:

* Pleural effusion compression,
* Pleural effusion infected or suspected of infection,
* Febrile patient (\> 38 ° C)
* Parapneumonic effusion
* Immunosuppression (eg, neutropenia \<1G / L, immunosuppressive therapy, ...)
* Portage known multidrug-resistant germ or S. aureus resistant to methicillin,
* Clinical suspicion of tuberculosis,
* Patients who have already been treated by pleurodesis,
* Contraindication to general anesthesia,
* Contraindication of prophylactic antibiotics,
* Contraindication to pleurodesis agent
* Increased bleeding risk,
* No one deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship)
* Pregnant or breastfeeding women.
Acute Mesenteric Venous Thrombosis.. in Assiut University Hospital Management Controversies

Initial treatment in the management of acute mesenteric vein thrombosis (MVT) is controversial. Some authors have proposed a surgical approach, whereas others have advocated medical therapy (anticoagulation). In this study, the investigators analyzed and compared the results obtained with surgical and medical treatment to determine the best initial management for this disease.

Mesenteric venous thrombosis (MVT) is increasingly recognized as a cause of mesenteric ischemia. it must be distinguished from arterial and non occlusive types of ischemia, it accounts for 5% to 15% of all cases of mesenteric ischemia. Patients may have evocative signs,such as abdominal pain that is out of proportion to physical signs, nausea, or vomiting. However, a clinical diagnosis is often difficult because abdominal symptoms are non specific and high index of suspicion is often required for diagnosis.(1) Primary MVT accounted for 25% to 55% of cases in early studies, but recent reports show decline in primary MVT because of improvements in the diagnosis of hypercoagulable states.(2) Advances in new imaging techniques also have enabled early recognition of this disease without or before laparotomy.(3-5 ) Fortunately , there is no consensus about the initial management of MVT; Some authors have proposed an aggressive surgical approach (6) while others have advocated an initial conservative management with anticoagulation and close monitoring . ( 7) similarly,issue of second look laparotomy,mandatory or selective is yet not resolved.

The present study is prompted to analyze our experience in an effort to resolve these controversies and the results obtained will be assessed to determine the best management strategy for this uncommon disease.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients admitted in the department of surgery in Assiut University diagnosed to have mesenteric venous occlusion not presented by signs of peritonitis or confirmed radiological signs of bowel infarction.

Exclusion Criteria:

1-Patients diagnosed to have mesenteric venous occlusion but with signs of peritonitis or confirmed radiological signs of bowel infarction on admission.
Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery

This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the effects of surgical site injection on pain and narcotic utilization in participants who undergo surgery for lower extremity fractures. 200 participants with lower extremity fractures who are admitted for operative fixation will be included in the study. Participants will be randomized to receive either a pain cocktail injection around the fracture site and surrounding tissues or control (no injection). An analysis of pain scores, rehabilitation progress, length of stay, narcotic utilization, and satisfaction scores will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Lower extremity fracture including femoral neck, intertrochanteric, sub-trochanteric, and femoral shaft fracture

Exclusion Criteria:

* Pregnant women
* Treatment with Arthroplasty
* Patients who receive a peripheral nerve block
* Patients who receive intra-op or post-op ketamine
* Patients with concomitant TBI or MR
* Polytrauma patients
* Pathologic Fractures
* Patients who live greater than 10 miles from NYU or who will not be followed by an NYU provider
* Patients with a contraindication to any of the medications on the study list due to other medical problems such as renal or liver disease or due to allergy/intolerance
* Patients with prior extremity weakness resulting from stroke or other neurological condition
* Prior or current history of narcotic use
* Patients with advanced dementia
* NYUMC Students, Residents, Faculty