cyrilzakka/clinical-trials huggingface dataset:
A Dyadic Intervention for Young Adult Patients with Cancer and Their Partner Caregivers

The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners.

Young adults (YA) with cancer have unique challenges in coping, and their primary partners may experience burden and low self-efficacy related to caregiving. In this single-arm pilot trial, the investigators shall deliver an eight-session intervention to YAs with cancer and their self-identified partners who provide caregiving. The intervention is founded on principles from cognitive-behavioral therapy and couples-focused interventions, tailored for YA. The aim of the study is to assess the feasibility and acceptability of the intervention, which will inform refinements prior to a larger-scale clinical trial. This study will include 10 YAs and their partner-caregivers (N=20). Participants will complete surveys at baseline and after the intervention, and will be invited to complete optional semi-structured exit interviews.

Eligibility Criteria:
Inclusion Criteria:

* Either: (1) Currently receiving active cancer treatment (n=5) or are within two years of completing active treatment (n=5) at Massachusetts General Cancer Center (MGHCC), located in Boston, Massachusetts, United States, OR (2) are the partner of an individual between the ages of 25-39 who is currently receiving treatment at MGHCC (n=5) or who has completed cancer treatment at MGHCC within the past two years (n=5)
* Either: (1) Indicates a score ≥4 on the National Comprehensive Cancer Network (NCCN) adapted distress thermometer study screening questions, OR (2) are the partner of a participant indicating a score ≥4 on the NCCN adapted distress thermometer study screening questions
* English-speaking

Exclusion Criteria:

• Uncontrolled psychosis, active suicidal ideation, or cognitive impairment
Cognitive Motion-Based Videogames Exploratory Study in Acquired Brain Injury

This study aims to assess the feasibility of Intendu Cognitive Motion-Based Videogames in Acquired Brain Injury (ABI) patients in inpatient treatment and in the community and to evaluate the effects of training on patients' cognitive performance

This study includes three experimental arms to research cognitive video games involving motion interaction in ABI population. The study consists of 4 primary phases: recruitment, assessment, intervention and post-intervention assessment. Two arms involve a randomized controlled study with inpatient participants, where participants are randomly assigned to an intervention or control group. Recruitment phase includes cognitive assessments to evaluate eligibility for the study. In the assessment and post assessment phases cognitive performance is established.

Intervention includes 10 computerized training sessions of 30-45 minutes over 3 weeks period using Intendu Functional Brain Trainer (FBT). The control group intervention involves playing commercial iPad games for the same duration. Interventions will be performed in addition to standard inpatient treatment.

In addition to the randomized control study, a third experimental arm will be performed, were participants living in the community will perform a similar protocol with cognitive motion-based video games. The recruitment, assessment, post assessment and intervention phases will be similar to the above.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Acquired Brain Injury.
2. At least one functional upper limb.
3. Ability to understand instructions that will be assessed by the therapist.
4. Basic cognitive ability in Orientation, Visual Perception and Spatial Perception.
5. Impairment in Executive Functions (EF) as assessed by EF assessments.
6. normal vision.

Exclusion Criteria:

1. Untreated epilepsy
2. Other Psychiatric or Neurological disease.
3. Neglect or Hemianopia.
4. For the Community arm - doesn't receive any cognitive therapy.
Study of an Exercise Program (STEP) for Youth With Concussion

To compare the efficacy of a sub-threshold aerobic exercise intervention provided with mobile health coaching (STEP-mhc) and a light stretching program (LS) to LS alone for 11-18 yo youth with persistent concussion symptoms.

This is a minimal risk randomized controlled trial whose aim is to test the efficacy of an exercise intervention (STEP) for youth 11-18 yo with persistent concussive symptoms (1-6 months inclusive). The investigators are utilizing an active control (light stretching). The primary outcome will be concussion symptoms measured with the Health-Behavior Inventory (HBI) in the first month after randomization. Long-term efficacy will be examined using standardized measures of quality of life and function over 6 months, and potential mediators will be explored including brain derived neurotrophic factor (BDNF), fear-avoidance and physical fitness. Physical activity will be measured with accelerometry to evaluate fidelity.

Eligibility Criteria:
Inclusion Criteria:

* Sports-related concussion that occurred 1-6 months inclusive prior to the start of the study, and was diagnosed by a clinician trained in concussion management consistent with the Zurich definition of concussion ("a complex pathophysiological process affecting the brain, induced by biomechanical forces \[that\] results in a graded set of clinical symptoms that may or may not involve loss of consciousness")
* Persistent symptoms as defined by the presence of at least 2 concussive symptoms (from the Health Behavior Inventory, or HBI) at the time of recruitment which were not present prior to injury
* 11 to 18 years of age (inclusive) at time of recruitment

Exclusion Criteria:

* Non-English speaking youth or parents
* Unwilling or unable to travel to Seattle Children's Hospital or Seattle Children's Research Institute twice during the course of the study
* Cervical spine or vestibular issues requiring further targeted intervention
* Other injuries or medical conditions in addition to concussion which would preclude vigorous exercise
* Psychiatric hospitalization in the year prior to enrollment
* Significant cognitive deficits such as mental retardation or autism
* Lack of worsening of concussive symptoms with exertion
* Significant abnormalities on routine brain imaging.
Natural History of Eosinophilic Esophagitis

Researchers are trying to understand the course of Eosinophilic Esophagitis (EoE), its progression and effects of treatments.

Investigators will identify patients from their database who have been diagnosed with Eosinophilic Esophagitis (EE) from the study period 2000 to 2008, based on clinical features and biopsy findings. Participants will be offered a follow up evaluation that includes: evaluation by the Principal Investigator, completion of questionnaires, Esophagram and Esophageal sponge (EsophaCap) cytology.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age and older
* Previous participation in the natural history followup study

Exclusion Criteria:

* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
* Pregnant women
Russian Kogenate Pediatric Study

A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Severe hemophilia A or moderate hemophilia A
* 1-12 years of age
* Requiring treatment with FVIII

Exclusion Criteria:

* Current or prior inhibitor or familial antecedents of inhibitor
* Surgery required during the study (9 months)
* Positive for HIV
Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).

The purpose of this study is to determine the efficacy and the tolerance on 15 days of a turmeric extract (Arantal®) on pain related to gonarthrosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 40 through 80 years of age
* Subject diagnosed with femorotibial osteoarthritis of the knee (diagnosed according to the clinical and radiologic criteria of ACR),
* Patient's Assessment of Arthritis Pain measurement on the last 24 hours of at least 50 mm on VAS,
* Patient has not received any NSAIDs within 72 hours and any analgesics within 24 hours,
* Patients with chronic knee pain (i.e., knee pain at least every other day during the month preceding inclusion),
* Patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, on radiography less than 12 months old),
* Patients having signed the informed consent,
* Patients capable of comprehend the study instructions.

Exclusion Criteria:

* Related to the osteoarthritis pathology:

  * Osteoarthritis linked to a metabolic arthropathy: chondrocalcinosis already diagnosed or defined by calcium edging on at least one femorotibial joint space, gout...,
  * Predominant associated symptomatic femoropatellar osteoarthritis,
  * Chondromatosis or villonodular synovitis of the knee,
  * Recent trauma (\< 1 month) of the knee responsible for the pain,
  * Knee joint effusion justifying an evacuation through puncturing,
  * Inflammatory flare (night pain, joint effusion) corresponding to a KOFUS score less than 7,
  * Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis...),
* Related to previous and associated treatments:

  * Corticosteroids injection in the previous month, whatever the joint concerned,
  * Hyaluronan injection in the evaluated knee during the previous 6 months,
  * Patient who took NSAID in the 72 hours prior to inclusion or Analgesics in the 24 hours prior to inclusion,
  * Slow-acting drugs for OA and/or dietary supplements taken within less than 3 months prior to the study product administration or for which the dose has been modified in the last three months (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...),
  * Anticoagulant treatment without gastric protection,
  * General corticotherapy,
  * Contraindication to paracetamol.
* Related to associated pathologies:

  * Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),
  * Peptic ulcer.
* Related to patients:

  * Pregnant or breastfeeding women
  * Pre-menopausal women with no contraception
  * Patients unable to write
  * Patients enrolled in a clinical trial in the previous 3 months
  * Patients under juristic protection or under guardianship.
Registry of PHAcoemulsification for Cataract Surgery

Cataracts cause vision loss due to opacities in the lens. Cataract surgery is performed by emulsifying the nucleus of the lens. A phacoemulsifier is the machine used to deliver ultrasonic energy in the eye to fragment the lens and aspirate the debris.

In contrast to the large number of cataract procedures performed worldwide, there is surprisingly scarce data regarding the intraoperative parameters used during phacoemulsification. As new technologies are made available to surgeons, this impedes a large-scale analysis of the benefits of the advances in phacoemulsifiers. The investigators aim to establish a nationwide registry with a database of intraoperative data recorded during the cataract procedures performed with the Centurion phacoemulsifier.

The data collected would encompass all parameters recorded in the phacoemusifiers' logs, such as the energy delivered in the eye (longitudinal, torsional and other), US time, BSS volume, duration of the procedure, surgeon settings and others. The objective will be to capture data from at least 100,000 procedures/year.

A nationwide registry will be established with a database of intraoperative data recorded during the cataract procedures performed with the Centurion phacoemulsifiers. The following intraoperative parameters used during the cataract surgery will be recorded and analyzed:

Primary endpoint: Ultrasound time (US time)

Exploratory endpoints:

* CDE : Cumulated dissipated Energy
* Total surgery time
* BBS volume
* Torsional and longitudinal energy
* IOP settings
* Vacuum settings Procedures performed with the Active Sentry module - where a pressure sensor is built in the phacoemulsifier handpiece will be compared to other to procedures performed without this module.

Data will be collected and analyzed from Centurions cases log extracted from at least 200 Centurions installed in France. Parameter and settings will be retrospectively analyzed.

A direct extraction of data from the machines will be processed for the analyses. No patient demographic data will be recorded.

The objective will be to capture data from at least 100,000 procedures and to run data analyses on a nationwide scale.

The database will serve as a basis to assess the technological advances aimed at reducing the amount of energy delivered in the eye, the duration of ultrasound use and overall the duration of procedures.

Eligibility Criteria:
Inclusion Criteria:

- All procedures recorded in Centurions (200 machines).

Exclusion Criteria:

* Opposition of the center to data collection.
* Complicated surgery (e.g. anterior vitrectomy) identified as such in the event log
Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.

This study will compare bifeprunox to a currently marketed medication, Zyprexa (olanzapine), with respect to the affect on weight during the treatment of outpatients with schizophrenia. The study will compare the effect of these medications on several variables, including body weight and triglyceride levels.

This is a multicenter, randomized, double-blind, parallel-group study of bifeprunox in the treatment of outpatients with schizophrenia, with olanzapine as the active comparator. Subjects must be stable for 3 months or more of treatment with olanzapine at baseline. There will be 2 treatment arms in this study, approximately 60 subjects per arm. After randomization and blinding, each subject will either remain on olanzapine or switch to bifeprunox. Assessments, including body weight and waist measurements, will be made at each study visit.Subjects will participate in the study for approximately 11 weeks. After a screening period of 6 to 14 days, eligible subjects will be treated for 8 weeks. Subjects who do not enter the long-term extension will return for a follow-up visit 7 days after discontinuing the use of test article. Subjects who do enter the long-term extension will have a 7-day taper/titration period after the 8 weeks of double-blind treatment.

Eligibility Criteria:
Inclusion criteria:

* Current treatment of at least 3 months with olanzapine.
* Primary diagnosis of schizophrenia.
* Total Positive and Negative Symptoms Scale (PANSS) score \<=70 at screening and baseline.

Exclusion criteria:

* Psychiatric diagnosis other than schizophrenia, as assessed by the modified Mini International Neuropsychiatric Interview (MINI), and considered by the investigator to be the primary psychiatric diagnosis.
* History or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study.
* History of any suicide attempt within 3 years of day -1 or significant immediate risk of violence or suicidality.
Effect of Vibration Stimulation Applied to Different Frequencies in Cortical Excitability and Muscular Function: Randomised Clinical Trial

The vibration stimulation is regarded as a new method of training and therapy to change afferent parts and cortical projections, which are important for motor control. This study aims to check effects of different frequency parameters for electrical cortical potentials and electrical muscular potentials in healthy young adults. 80 volunteers will participate in the study, and they will be randomly subdivided in four groups for trials. The methodology consists of electroencephalographic and electromyographic assessment before and after 15-minute vibration application with a digital vibratory pad.

The vibratory stimulation is regarded as a new training method and capable of modulating peripheral afferents and cortical projections therapy, which are important in motor control. This study aims to determine the effects of different parameters on cortical frequency electric potential and electric potential muscle in healthy young adults. Will participate in the study 80 volunteers, these randomly divided into four groups for the experimental procedures. The methodological approach consists of an electroencephalographic and electromyographic evaluation before and after 15 minutes of application of vibration through a digital vibrating pad.

Eligibility Criteria:
Inclusion Criteria:

* Physically and mentally healthy
* Right-handed volunteers who are not using psychoactive or psychotropic substances,
* Have nourished themselves up to three hours before the experiment.

Exclusion Criteria:

* Under 18-year- and over-60-old volunteers
* who do not fit into using data collection equipment,
* individuals who have slept less than six to eight hours the night before the experiment,
* who have already undergone vibration training and had problems with using it.
Integrated Neuromuscular Inhibition, Muscle Energy and Strain Counter Strain Techniques in Neck Pain

1. To determine effects of Neuromuscular Inhibition, Muscle energy and strain counter strain techniques on Pain, disability, pain pressure threshold, range of motion, and health-related quality of life in mechanical neck pain.
2. To compare the effects of Integrated Neuromuscular inhibition, Muscle energy and strain counter strain techniques in the Management of mechanical neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Participants falling in this category would be recruited into the study.

  * Patients with chronic mechanical neck pain (symptoms for more than 3 months).
  * Age group between 30 - 60 years.
  * Patients willing to participate and take treatment.
  * Patients must have at least 1 active trigger point at upper trapezius, levator scapulae, SCM.
  * Gender (Both)
  * VAS \>3

Exclusion Criteria:

* • Patients having severe neck pain.

  * Patients having any systemic joint pathology, inflammatory joint disease (e.g rheumatoid arthritis, gouty arthritis, psoriatic arthritis).
  * Patients who had any neurological deficit, myelopathy any mental illness.
  * Patients on medication like antidepressants, corticosteroid, anti-inflammatory medications.
Levofloxacin Triple and Bismuth Quadruple Therapies for Rescue Treatment of H Pylori Infection

From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) or EBTL (esomeprazole 40 mg b.d., bismuth 500 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.) therapy for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.

Eligibility Criteria:
Inclusion Criteria:

* positive results of both rapid urease test and histology,
* a positive result of urea breath test,
* or a positive result of culture.

Exclusion Criteria:

* ingestion of antibiotics, bismuth, or proton pump inhibitor（PPI）within the prior 4 weeks,
* patients with allergic history to the medications used,
* patients with previous gastric surgery,
* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
* pregnant women
Intravascular Injection Incidences During Lumbar Medial Branch Block

The purpose of this study is to compare using oblique fluoroscopic angle has any advantage in reducing the incidence of vascular punture and technical easiness during lumbar medial branch block

In previous report, the use of oblique fluoroscopic angle during S1 transforaminal injection demonstrated technical easiness and reduced intravascular injection incidences. For the procedure lumbar medial branch block, both anteroposterior and oblique fluoroscopic angle are possible. Usually, which approach method to use is determined according to the physician's preferences.

The final target for lumbar medial branch block is the junction betweeen superior articular process and transverse process. This target can be easily confirmed under the scotty dog appearance. If we use oblique fluoroscopic angle, this approach (30 degree) can make scotty dog appearance more visible so that physician can identify bony landmark more easily for lumbar medial branch block. For beginners, oblique fluoroscopic approach seems to provide more advantages in identifying bony landmark. However, it is uncertain whether this approach can provide technicaL easiness and reduce the intravascualr injection incidences.

Eligibility Criteria:
Inclusion Criteria:

* facet joint arthropathy

Exclusion Criteria:

* allergy to local anesthetics or contrast medium
* pregnancy
* spine deformity
* neurologic abnormality
Assisted Promontofixation Using Glue Versus Promontofixation Using Threads (PROCOL)

The treatment of gynecological prolapse (organ removal) can be done by laparoscopy or vaginally. Laparoscopy is used in 1 out of 2 cases, but learning is difficult and operation time is long. One of the technical difficulties is related to the sutures to the threads. Some surgeons therefore use a glue to fix prosthetic reinforcements more easily and quickly, but this sizing technique has only been evaluated very little. Our study proposes to compare the technique of suture with the thread at the gluing of the prostheses in order to validate the merits of this new technique

Laparoscopic promontofixation is a surgical technique considered by some as the reference technique. Its difficulty of learning and the duration of operation are factors limiting its diffusion. The use of cyanoacrylate glue is proposed to simplify the procedure, without there being any comparative studies between the sutures over and the sizing of prosthetic reinforcements.

The main objective of the study is to compare the operative time of promontofixation by coelioscopy with suture using threads to promontofixation using glue.

Secondary objectives are the comparison between the two groups of complications per and postoperative, objective anatomical results and functional results of the tissue reaction judged by clinical examination (palpation) and ultrasound and direct cost.

Eligibility Criteria:
Inclusion Criteria:

1. Age\> 40 years
2. Surgical indication of prolapse cure by promontofixation
3. Valid social insurance
4. French spoken and written
5. Informed consent signed
6. No exclusion criteria

Exclusion Criteria:

1. Concomitant rectopexy
2. Concomitant Hysterectomy
3. Associated surgical procedure not compatible with measurement of operative time
4. Refusal to participate in the study
5. Pregnant or lactating woman (Article L 1121-5 of the french code of public health)
6. Vulnerable persons (Article L 1121-6 of the french code of public health)
7. Majors subject to legal protection or unable to express their consent (Article 1121-8 of the CSP)
8. Participation in another protocol for less than 3 months
9. Patient does not have all the inclusion criteria.