cyrilzakka/clinical-trials huggingface dataset:
Orthotics, Pain & Fear of Falling

To investigate and compare the use of a prefabricated Orthotic, with and without a metatarsal pad in decreasing pain and fear of falling in older adults.

It is estimated that around 24% of community-dwelling adults over the age of 45 experience frequent foot pain. Falls and fear of falling are also significant issues in this population as both can result in avoidance of activities and decreased physical performance. In cases where fear of falling decreases physical performance and increases activity avoidance, it actually becomes a risk factor for falling itself.

Previous studies have shown that various types of Orthotic insoles improve balance and reduce lower-extremity pain in older adults. However, research which directly compares the effects of two different types of insoles is limited. Hence, this randomised control trial will investigate and compare the use of a prefabricated Orthotic, with and without a metatarsal pad, in decreasing pain and fear of falling in older adults.

This randomised control trial will be conducted over a 6-week period. The study population will include 206 participants who will be randomised into 2 groups (Group A and Group B). Participants in Group A will receive an Orthotic with a metatarsal pad and participants in Group B will receive a neutral Orthotic without the metatarsal pad. All participants will be required to continue with usual activities, using the Orthotic wherever possible for a period of 6 weeks. Participants will be asked to provide data in the form of completed surveys twice, once at the study onset and once at the end.

Eligibility Criteria:
Inclusion Criteria:

* A least 60 years of age
* Live in a community-based setting
* Are capable of ambulation
* Have some form of self-identified foot pain

Exclusion Criteria:

* Compromised skin integrity of the lower limbs
* Peripheral neuropathy and lack of sensation in the feet.
* Previous history of foot surgery and
* Inability to follow the instructions and procedures of the research protocol.
Electromyography During Common Exercises Used in Rehabilitation

It is generally accepted that the effectiveness of an exercise can be controlled not only by the weight or resistance applied but also by doing an exercise that would better target the desired muscle. The purpose of this study is to obtain objective information regarding selected lower extremity muscle activity during specific exercise and the influence of fatigue and speed on muscular activation.

It is generally accepted that the effectiveness of an exercise can be controlled not only by the weight or resistance applied but also by doing an exercise that would better target the desired muscle. Information regarding selected lower extremity muscle activity during specific exercise and the influence of fatigue and speed on muscular activation may enhance exercise prescription for all parties involved. Specifically, selection of specific training or rehabilitation exercises may be guided by increased awareness of specific muscle activation patterns during common exercises.

Methods and Measures: Healthy subjects between 18 - 35 years old will be recruited from the community by a sample of convenience and word of mouth. Potential participants will report to the Institute for Human Performance. The potential participants will be asked to complete all documentation including informed consent, and health screening questionnaire. The qualified participants will be familiarized with the set up and specific exercises. If eligible, surface EMG recordings will be collected from the back extensors, gluteal muscles (buttocks), hamstrings (posterior thigh), quadriceps (anterior thigh), and gastrocnemius (calf) during squat and lunges exercises.

For data analysis, a within subject measures analysis will be conducted using general linear models. Specifically, we will use paired t-tests and an analysis of variance (ANOVA). When applicable, post-hoc tests will be used to uncover differences among the groups of subjects on descriptor variables such as age, height, weight, rate of perceived exertion, and maximal and sub-maximal voluntary muscle performance variables (i.e. EMG amplitude, frequency). The statistical significance level will be set at alpha = 0.05 for all analyses performed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults age 18-35

Exclusion Criteria:

* Subjects who report any significant respiratory-cardiovascular disease, which is not yet under control.
* Known orthopedic risks to strength training exercise
Role of Ultrasonography in Acute Abdomen in Adults in Correlation to Computed Tomography Scan

The study aims to evaluate the role of Ultrasonography in the diagnosis of the cause of acute abdominal pain in 50 adults presenting in the ER at Sohag University Hospital and compares it to the Computed Tomography scan results of the same patients to discover the superiority of both over the other in the diagnosis of different acute abdomen cases.


Eligibility Criteria:
Inclusion Criteria:

* Adults presented with Acute abdominal pain.

Exclusion Criteria:

* less than 18 years old patients
* Pregnant women
Alcohol and Employment

The purpose of the study is to determine whether welfare-to-work schemes combined with alcohol treatment are more efficient than a welfare-to-work scheme alone, for unemployed citizens with alcohol problems.

Background and purpose: The Tryg Foundation Denmark has awarded funds for a study that tests how to most efficiently combine welfare-to-work schemes with efforts against alcoholism, in relation to a return to the labour market.

The study will be carried out in a number of Danish municipalities in the time frame 2011-2014.

The purpose of the study is to determine whether a welfare-to-work scheme combined with alcohol treatment is more efficient than a welfare-to-work scheme alone, for unemployed citizens with alcohol problems.

Design: If the welfare recipient meets the inclusion criteria, then the recipient is provided with information about the project by the caseworker. If the recipient wishes to participate in the project he/she is asked to fill out a consent form and a questionnaire regarding employment status, alcohol consumption, other habits of abuse, health status and background information.

Welfare recipients who do not wish to participate will as usual be referred to the welfare-to-work schemes deemed most appropriate by the caseworker.

The intervention is designed as a randomized controlled trial, where heavy drinkers who meet the inclusion criteria and wish to participate will be allocated to either:

A) An intervention group receiving welfare-to-work scheme combined with alcohol treatment.

or

B) A control group receiving only welfare-to-work scheme.

After 6 and 12 months there will be a follow-up where participants will be asked to answer a questionnaire with questions about their employment status, alcohol consumption, other habits of abuse, health status and background information.

In this study ANCOVA is chosen to analyses the effective of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have an audit-score above 7.
* Participants must be unemployed and receive welfare-to-work schemes when included.

Exclusion Criteria:

* Participants who have an audit-score below 8.
* Participants who have a normal job.
Adolescent Survivors of Cancer or Similar Illnesses

The purpose of this study is to examine the health behaviors of young adults who have been treated for cancer, leukemia, or similar illnesses. We will also ask you some questions about your family members' and friends' health behaviors. We plan to use the findings from this study to design new programs to help teenage cancer survivors resist doing things that might harm their health.

This study proposes to explore cancer-risk behaviors and future behavioral intentions among adolescent cancer survivors (i.e., 14-19 years old) and compare them to their "healthy" peers using population-based normative data. Additionally, it seeks to determine the significant theory-driven covariates related to adolescent survivors' health behaviors, which will aid in the design of future behavioral interventions.

Eligibility Criteria:
Inclusion Criteria:

* Current age at enrollment between 14 and 19;
* A diagnosis of cancer between the ages of 8 and 14;
* At least 12 months post-treatment and no evidence of disease (NED) at the time of assessment;
* Can be reached by mail or telephone;
* Fluent in English;
* Parent or legal guardian able to provide informed consent;
* Able to provide informed assent.

Exclusion Criteria:

* Major psychopathology or cognitive impairment likely in the judgment of the investigator to interfere with participation and compliance with the protocol.
* Currently receiving therapy for cancer treatment
Outcomes of Uterine Rupture

Uterine rupture (UR) is a serious, life-threatening obstetric complication. UR is associated with an increased risk of maternal and perinatal morbidity and mortality, particularly in developing countries compared to developed countries. UR occurs mainly as a consequence of poorly managed labour


Eligibility Criteria:
Inclusion Criteria:

* women with ruptured uterus
* accept to share in the study

Exclusion Criteria:

* women refuse to participate
Study Evaluating the Persistence, Efficacy and Tolerability of Methotrexate in Inflammatory Bowel Disease Patients

Methotrexate is one of the immunosuppressants used in chronic inflammatory bowel disease (IBD). It is indicated as monotherapy for induction and maintenance treatment of Crohn's disease (CD), or in combination with anti-tumor necrosis factor (TNF) agents for prevention of immunization.

The main objective is to assess the persistence rate of methotrexate treatment in patients followed for chronic inflammatory bowel disease (IBD).

Methotrexate is one of the immunosuppressants used in chronic inflammatory bowel disease (IBD). It is indicated as monotherapy for induction and maintenance treatment of Crohn's disease (CD), or in combination with anti-tumor necrosis factor (TNF) agents for prevention of immunization Thiopurines are the most commonly used immunosuppressants in IBD, which contrasts with rheumatology data where methotrexate is the first-line immunosuppressant. Thiopurines and methotrexate have equivalent efficacy in CD 4.

Methotrexate is available in injectable (intramuscular (IM) or subcutaneous (SC)) or tablet form. In IBD, only parenteral administration has been shown to be effective. There is no consensus on the optimal maintenance dosage.

Tolerance problems remain an obstacle to its use, even if the side effects are not severe.

In this context, the objectives of this study are to describe the use of methotrexate in current practice in patients followed for IBD, its persistence, compliance, tolerance, as well as the factors associated with the persistence of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Person who has received full information on the organization of the research and has not objected to the use of this data
2. Age ≥18 years
3. Certain diagnosis of IBD (European Crohn's Colitis Organization criteria)
4. Introduction of methotrexate mono- or combination therapy between January 1, 2015 and December 31, 2022
5. Minimum 6-month follow-up after initiation of methotrexate therapy
6. Person affiliated with a social security plan or beneficiary of such a plan

Exclusion Criteria:

1. Age \<18 years
2. Person referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code

   * Pregnant woman, parturient or nursing mother
   * Minor (not emancipated)
   * Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
   * A person of full age who is unable to give consent
3. Persons deprived of liberty by a judicial or administrative decision, persons under psychiatric care by virtue of articles L. 3212-1 and L. 3213-1
NO Need to Ventilate: A Trial of Non-invasive Inhaled Nitric Oxide in Persistent Pulmonary Hypertension of the Newborn

The primary objective of the trial is to determine the feasibility and clinical safety and efficacy of non-invasive inhaled nitric oxide in infants with PPHN without significant pulmonary +-parenchymal disease who would normally receive inhaled nitric oxide only after placement of a tracheal tube and the institution of mechanical ventilation.

Blending low doses of NO gas with oxygen in the inspiratory limb of mechanical ventilators is an effective method for reducing pulmonary vascular resistance and decreasing extrapulmonary right-to-left shunting at the ductus arteriosus and foramen ovale in many patients with PPHN. However, in some patients with PPHN, sustained elevations of PVR may occur in the absence of or despite improvement in the parenchymal lung disease such that mechanical ventilation is not needed for maintaining adequate gas exchange.

PPN in the absence of pulmonary parenchymal disease or despite improvement in the parenchymal lung disease occurs in a significant subset of newborn infants with hypoxemic respiratory failure. Inhaled NO can be effectively delivered by non-invasive techniques to newborn infants with PPHN, potentially reducing the duration of mechanical ventilation, while safely treating the elevation in pulmonary artery pressure and right-to-left.

A dose of 10-20 ppm measured within the delivery device is sufficient to maintain nasopharyngeal concentrations within a range of 1-10 ppm. My co-authors and I have also reported a series of eleven infants with pulmonary hypertension treated with low dose iNO delivered via nasal cannula after extubation at the 14th Annual CNMC Symposium on ECMO \& Advanced Therapies for Respiratory Failure, Keystone, CO, 1998.

Eligibility Criteria:
Inclusion Criteria:

* Newborn infants \>/= 34 weeks with clinical or echocardiographic evidence of PPHN with a PaO2 \< 100 of Fio2 0.8 who are not mechanically ventilated

Exclusion Criteria:

* Infants with significant lung disease
* Inability to sustain spontaneous respirations
* Lethal congenital anomalies
* Severe birth asphyxia
Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT).

FMT will ameliorate colitis via alterations of patients' microbiota and their proteolytic-dependent effect on epithelial permeability.

Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal enemas. The treating physicians and the patients will be blinded for the treatment arm.

At the FMT visit (first week), blood and stool samples will be taken and patients will be filling out questionnaires to assess disease activity level.

Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT, patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as well.


Eligibility Criteria:
Inclusion Criteria:

* Over 3 month diagnosis of ulcerative colitis
* Active Colitis disease with endoscopic score \>0
* Ability to sign an informed consent

Exclusion Criteria:

* Acute neutrophilia (under 500 neutrophils)
* Clostridium difficile infection
* Exposure to antibiotics 2 weeks prior to enrollment.
* Severe immune deficiency
* Hospitalization
* Proctitis involving less than 10cm of the rectum
* Malignancy with the past 5 years (excluding BCC)
* An unstable dose of steroids or 5ASA (5- aminosalicylic acid) with the past 2 weeks or of immunomodulators or biologic therapy within the past 12 weeks
Clinical Use of Cold and Contact Heat-evoked Potentials: Normative Values

This prospective interventional study aims at recording contact heat evoked potentials (CHEPs) and cold evoked potentials (CEPs) in a healthy population sample in an aim to derive normative values which could be used to evaluate evoked potentials (EPs) of patients.

Population sample of 80 healthy volunteers between 26 and 75 years old will be recruited and will be categorized into 5 age subgroups (26-35, 36-45, 46-55, 56-65, 66-75 years old).

Upon arrival, participants will be reminded of the aims and of the content of the experiment. After informed consent (recorded in writing), healthy subjects will be screened with a baseline examination:

1. brief neurological examination
2. sensory nerve conduction study-related
3. quantitative sensory testing

If the baseline examination screening is considered normal, CEPs and CHEPs will be performed. To avoid bias, the side and order of the tests will be randomized.

All thermal stimuli for CEPs and CHEPs will be delivered delivered using a contact thermal stimulator (TCS model II.1, QST.Lab, Strasbourg, France).

Only stimuli that are safe and acceptable for the subject will be used in the study, and all experimental procedures can be interrupted at any time by the participant, with no detrimental effect.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 26 and 75 years old having a normal baseline testing.

Exclusion Criteria:

* Age\<26 and \>75 years old
* Known neurological condition.
* Acute or chronic pain condition.
* Currently taking drugs that may influence the recording of evoked potentials (analgesics, psychotropic substances, antiepileptics...).
* History of neurological, or metabolic disorder.
* Inability to complete study task.
* History of chemotherapy.
* Habitual substance abuse(alcoholic beverages intake \>21 units/week for males, \>14 units/week for females.)
* Being a volley ball player (due to risk of modified sensibility of the volar forearm skin)
* Abnormal baseline neurological, SNC or QST testing
Medication Adherence in Patients With Inflammatory Bowel Disease (IBD)

The purpose of this is to formally assess health literacy and medication adherence in participants with Inflammatory bowel disease (IBD). The study also aims to improve medication adherence, health-related quality of life, and disease activity through a 24-week intervention.

The purpose of this study is to formally assess health literacy and medication adherence in participants with Inflammatory bowel disease (IBD). The study also aims to improve medication adherence, health-related quality of life, and disease activity through a 24-week intervention that will include telephone reminders, educational materials, visits to the physician, and financial counseling.

Eligibility Criteria:
Inclusion Criteria:

* New or existing diagnosis of inflammatory bowel disease (IBD) proven via endoscopy, pathology, and radiology findings
* Maintained or started on a medication for inflammatory bowel disease at the time of enrollment
* Ability to speak English
* Good hearing
* Phone availability

Exclusion Criteria:

* Pregnancy or plans to be pregnant
* Inability to make own health care decisions
* Inability to participate in the study phone calls
* Uncontrolled psychiatric illness
* Enrollment in another clinical trial outside of the standard clinic IBD registry
Effectiveness of Multimedia Exposure in Patients Transferred to Hospital Suffering From Acute Myocardial Infarction

Randomised clinical trial, single-center, blinded assessment, controlled with standard practice with two-group parallel design.

Eligible patients are those assisted and transferred suffering from ST-Elevation myocardial infarction in an Advanced Life Support ambulance from an public Emergency Medical Service in the Cadiz area (Spain).

Experimental group will watch an ad hoc design multimedia content in a tablet (video with sound and subtitles) during the transfer and control group will be assisted as standard procedures.

Main outcome variables will be conformed by patient reported outcomes (anxiety State, pain and comfort) and patient experience (transfer experience).

Due to intrinsic characteristics of ambulance transport raises stress or anxiety in patients. Moreover, other outcomes such as pain and some specific vital signs are affected. In the last years, empowerment patient strategies have been launched in several clinical settings but none in the ER field.

Main objective Comparative assessment of the effectiveness of multimedia exposure vs standard clinical procedures to improve the experience and patient reported outcomes in patients suffering from ST-Elevation myocardial infarction transferred to hospital in an Advanced Life Support ambulance for a percutaneous coronary intervention (PCI).

Methods Randomised clinical trial, single-center, blinded assessment, controlled with usual practice with two-group parallel design.

Eligible patients are those assisted and transferred suffering from STEMI in an Advance Life Support (ALS) ambulance from public Emergency Medical System in the Cadiz region.

Experimental group will watch multimedia content on a tablet (movie or image with sound) ad hoc designed, control group will be assisted as usual procedures.

Main outcomes will be conformed by informed patient results (anxiety State, pain and comfort) and patient experience (transfer experience).

Eligibility Criteria:
Inclusion Criteria:

* All genders patients.
* Assisted by ALS ambulance.
* Diagnosed with STEMI, "Killip I".
* Transferred by an ambulance to the hospital to receive a percutaneous coronary intervention.
* Informed consent must be signed.
* Conscious and oriented patients.

Exclusion Criteria:

* Sedation and/or assisted ventilation.
* Blinded or visual defects.
* Deafness.
* Severe mental disorders or behavior disorders.
Managing Pain and Symptom Burden Caused by Chemotherapy in People With Myeloma or Lymphoma

The purpose of this study is to find out whether acupuncture treatments can reduce the need for opioid medication when managing pain caused by chemotherapy. The study will compare the effects of adding acupuncture to usual pain management with those of usual pain management alone, in reducing opioid use by relieving pain. Researchers also want to find out more about the effects of acupuncture treatments on other symptoms caused by cancer treatments and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* pathological diagnosis of MM, HD or NHL
* scheduled for high dose chemotherapy for auto-HSCT in the following month (30 days)
* not taking opioids regularly in the week prior to consent (one-time dosing of opioids for a painful procedure is allowed)

Exclusion Criteria:

* absolute neutrophil count (ANC) of \<500/μl, platelet count of \<20,000/ μl or INR \>2.0
* acupuncture within two weeks prior to HiChemo (to avoid residual effects of acupuncture)
* unable to provide informed consent