cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of MgLiTT for Medical Refractory Epilepsy

Multicenter, open-label, prospective designed study to characterize the performance of MRI-guided laser interstitial thermal therapy (MgLiTT) using the Sinovation Laser Ablation System for the treatment of medical refractory epilepsy.

The Sinovation Laser Ablation System uses robot-assisted, precise, high-intensity laser light to initiate necrosis of abnormal brain tissue through thermal ablation while limiting injury to adjacent healthy tissue. MgLiTT has the advantages of precision, minimal invasive procedure and real-time thermal monitoring.

Subjects who meet the study eligibility criteria and sign the informed consent form will undergo the MgLiTT procedure. Subjects, or their caregivers, are required to keep a seizure diary throughout the study, beginning after surgery. The study will monitor and record subjects' seizure frequency, antiepileptic medications, and physical and emotional health.

Subjects treated with Sinovation Laser Ablation System will have at least 9 months of follow-up. Throughout study participation, the study investigator will continuously monitor and document both effectiveness and safety data at study appointments.

Eligibility Criteria:
Inclusion Criteria:

* The age ranged from 6 months to 70 years old;
* Previous diagnosis of drug-resistant epilepsy with focal lesions;
* The average seizure frequency was more than 2 times/month within 3 months;
* Surgical treatment is suitable for epilepsy;
* The subjects or their guardians can understand the purpose of the trial, show adequate compliance with the trial protocol, and sign the informed consent form.

Exclusion Criteria:

* MRI contraindication;
* Patients with severe coagulation dysfunction;
* Pregnant or lactating women;
* Subjects who have participated in clinical trials of any other drugs or medical devices within 3 months;
* Evidence of severe or uncontrollable systemic diseases, as judged by the researchers;
* Subjects considered unsuitable for the clinical trial.
Novel Executive Function Training for Obesity

Currently, the best behavioral treatments for obesity only work for 50% of adults, and of those who initially succeed, most do not maintain their weight loss. One reason for this failure may be due to neurocognitive deficits found among individuals with obesity, particularly related to executive function, which make it difficult for these adults to adhere to treatment recommendations. The proposed study aims to develop a Novel Executive Function Treatment (NEXT), which when administered prior to the behavioral treatment, could help improve outcomes by addressing the neurocognitive deficits in adults with overweight or obesity.

First, to assist with treatment development, two groups of approximately 10 participants will be enrolled in a 12-week open-label treatment group of NEXT. These participants will then provide qualitative feedback to help with treatment development. After the two pilot groups, a randomized control trial will evaluate NEXT compared to standard BWL to assess feasibility, acceptability and preliminary efficacy. Treatment will be 6 months long and assessments will occur at baseline, mid-treatment, post-treatment and 6-months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Ability to read English at a 6th grade level
* BMI \>25 and ≤45
* Difficulties with executive functioning

Exclusion Criteria:

* Medical condition that requires physician monitoring to participate in weight control program or prohibits safely participating in recommended physical activity
* Psychiatric condition that could interfere with program participant (e.g., substance abuse, suicide attempt within previous 6 months, active purging)
* Currently pregnant, lactating or plan to be in the timespan of program follow-up
* Current enrollment in an organized weight control program
* Change in psychotropic medication or other medication that could have impact on weight during the previous 3 months
* History of bariatric surgery
* History of learning disorder, neurological condition or injury
Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy

130 pregnant women with Iron deficiency anemia, in the 2nd trimester (microcytic hypochromic anemia, hemoglobin range from 9-10.5g/dl, serum ferritin less than 12 ng/ml), from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt, will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, packed-cell volume (PCV) , mean cell volume (MCV), mean corpuscular hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), Serum ferritin will be done at the start and the end of the treatment period.

The study will includes130 pregnant women, from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt. Women should be diagnosed as having iron deficiency anemia, in the 2nd trimester (complete blood count, showing microcytic hypochromic anemia, hemoglobin range from 9-10.5, serum ferritin less than 12 ng/ml). Women will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, PCV, MCV, MCH, MCHC, Serum ferritin will be done at the start and the end of the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant with singleton intrauterine pregnancy
* 14- 20 weeks of gestation
* Have iron deficiency anemia (IDA) with hemoglobin 9 to less than 10.5 g/dl.

Exclusion Criteria:

* Patients with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemic trait).
* Hemoglobin less than 9 g/dL.
* Clinical and/or laboratory evidence of hepatic, renal, hematologic, cardiovascular abnormalities.
* History of acid-peptic disorders, esophagitis, or hiatal hernia.
* Family history of thalassemia, sickle cell anemia, or malabsorption syndrome.
* Medical disorders with pregnancy.
* Bleeding in early pregnancy.
* Allergies to milk proteins / hypersensitivity to iron preparations.
* History of ingestion of any hematinics within the last 1 month before study entry.
* Recent blood transfusion.
* Refusal to participate in the study.
Resilience in Girls Victims of Sexual Abuse

İn this study, it was aimed to examine the effectiveness of the psychological resilience program for adolescent girls after sexual abuse.This study is a randomized controlled trial.

Sexual abuse, which is a universal problem, affects the functioning of many institutions of society and can lead to lifelong physical, mental and social problems and health problems for children.The process of coping and adapting to stressful challenges such as sexual abuse is explained by psychological resilience.

Social support provided by parents, peers and professionals from the onset of sexual abuse contributes positively to children's lives and facilitates adaptation.Group therapies to be applied to abuse victims can increase perceived social support by reducing negative effects such as shame and stigmatization.

Eligibility Criteria:
Inclusion Criteria:

* Having applied to a child advocacy center due to sexual abuse
* Being a girl in the 11-18 age group
* The cognitive competence required to maintain the measurement tools and the training process to have
* Volunteering to participate in the research
* Being open to communication and cooperation
* No severe psychiatric disorder (such as psychosis, neurosis)
* The child can become literate (to be able to use assessment tools)

Exclusion Criteria:

* Not wanting to participate in the research
* To continue the group training or to fill in the measurement tools to be applied cognitive and physical dysfunction that would constitute an obstacle.
A Feasiblity Study of Green Activity Program for People Living With Memory Challenges

The purpose of this study is to test the Green Activity Program that was designed with people living with memory challenges and their study partners to see if it can be done and if they enjoy the program. "Green activities" are nature activities that the person enjoys and can be done with other people or pets. For example, dog walking, hiking, outdoor yoga, and gardening are all green activities. The purpose of the program is to help people living with memory challenges participate in nature activities they enjoy. The goal of the program is to help people stay active and improve their health and well-being.

This is a single arm pre/post feasibility study lasting up to 1 year. Investigators will recruit in n=40 dyads (people living with memory challenges and their study partners n=80 total) and expect n=30 (n=60 total people living with memory challenges and study partners) to complete the 12-week GAP and evaluate it for feasibility and acceptability. Anonymous program evaluation surveys will be administered either via paper or RedCap survey to the outdoor activity professionals who participated in the study. Brief recorded phone interviews (5 minutes) will be conducted with the people living with memory challenges and their study partners after the intervention and 15-minute brief calls with the outdoor activity professionals will be used to gather feedback to refine the program. Informal conversations with the occupational therapist(s) delivering the intervention will occur to identify areas for refinement and will be documented with anonymous notes and no identifiable data collected from them. Sustained behavior change will be measured in people living with memory challenges at 4 weeks after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* 45 years or older
* Has memory challenges or difficulties thinking
* Have access and ability to respond to the telephone (mobile or landline)

Study partner

* 18 years or older
* Speaks Spanish or English
* Identified by the PLMC as a person they feel comfortable with who they would like to join them in the study. The study partner's participation is based on level of support needed for the PLMC.

Outdoor activity professionals

* 18 years or older
* at least 1 year experience providing outdoor activities

Exclusion Criteria:

* Participants living with memory challenges will be excluded if they do not meet inclusion criteria or if they indicate any of the following on the 2023 Physical Activity Readiness Questionnaire + (PAR-Q+)

  * Heart failure or difficulty controlling Coronary Artery Disease, Diagnosed Abnormality of Heart Rhythm, or other cardiovascular condition.
  * Cancer and are actively receiving therapies
  * Experienced a black out, fainted, or lost consciousness as a result of a head injury in the past 12 months.
  * Often experienced signs and symptoms of low blood sugar (hypoglycemia) following exercise and/or daily activities.
  * \>3 hospitalizations in the past year
Early Tobacco Abstinence - 5

This proposal will conduct a prospective examination of the clinical course (intensity, content and duration) of tobacco (nicotine) abstinence effects in male and female smokers who are either heavy/light alcohol drinkers with/without depressive symptoms.

1. To compare male and female smokers, with and without current depressive symptoms, in a prospective study of the intensity, content \& duration of nicotine abstinence effects during an eight-day abstinence period, and responses to cue exposure (invivo cigarette cues, alcohol and negative affect-inducing imagery cues) during acute vs. prolonged abstinence and,
2. To compare male and female smokers, who are either heavy alcohol drinkers or light alcohol drinkers, in a prospective study of the intensity, content \& duration of nicotine abstinence effects during an eight-day abstinence period, and responses to cue exposure (invivo cigarette cues, alcohol and negative affect-inducing imagery cues) during acute vs. prolonged abstinence.

Eligibility Criteria:
Inclusion Criteria:

1) between ages 18-60 years; (2) able to read and write English (3) SMOKER: Smoking \>10 cigarettes per day for at least 1 year, with CO \> 10 ppm, and blood cotinine concentration of 150 ng/ml or greater, FTND scores \> 5.

(4) DEPRESSED SUBJECT: Not meeting SCID criteria for current major depression or more than one past major depressive episode, but having scores \> 10 on the CES-D indicating presence of depressive symptomatology (5) NON-DEPRESSED SUBJECT: Not meeting SCID criteria for current major depression or more than one past major depressive episode, CES-D scores \<10.

(6) HEAVY DRINKER: Not meeting SCID criteria for current alcohol dependence; drinking 20 or more drinks per month.

(7) LIGHT DRINKER: Not meeting SCID criteria for current alcohol dependence; drinking ten drinks or less per month

Exclusion Criteria:

1. Current dependence on cocaine, marijuana, opiates or alcohol
2. Positive urine screen for marijuana, cocaine or opiates at any appointment after the intake appointment.
3. Regular use of any psychoactive drugs including anxiolytics and antidepressants;
4. Current major depression or other psychiatric conditions
5. Subjects with any significant, untreated current medical conditions condition such as neurological, endocrine, cardiovascular, renal, liver, thyroid pathology or on medications for any recent medical events 6) Pregnant or lactating women -
Non-interventional, Retrospective, Multi-center Study to Evaluate Non-motor Symptoms in Advanced Parkinson Disease (PD) Patients Already Treated With Rotigotine

This is an observational, non-interventional and retrospective study in patients with advanced PD who have been treated with Rotigotine (Neupro®) as prescribed by physicians according to usual clinical practice in Spain.

The Primary Objective will be to evaluate Non-Motor Symptoms (NMS) in advanced PD patients who have been treated with Rotigotine for at least 6 months.


Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in this study, all of the following criteria must be met:

* Male and female ambulatory patients with Parkinson's disease diagnosis (as per the London Brain Bank diagnosis criteria) ≥6 months ago
* Patient aged 30 years or older at the time of Parkinson's disease diagnosis
* Patients who were under treatment with Rotigotine following routine clinical practice, either alone or in combination with Levodopa, and in an advanced PD dosage (≥ 8 mg/ 24 h) for at least the previous 6 months
* Patients under treatment with Rotigotine (≥ 8 mg/ 24 h) who were assessed twice of NMS by means of the PDNMS-Q 6 months apart
* Patients are currently informed and have been given enough time and opportunity to think about participation (data collection) in the study and have given written informed consent

Exclusion Criteria:

Patients are not permitted to enroll in the study if any of the following criteria is met during the previous 6 months:

* Patients have other Parkinsonian syndrome different than Parkinson´s disease
* Patients have a history of Pallidotomy, Thalamotomy, Deep Brain Stimulation or Fetal Tissue Transplant
* Patients with Dementia, active Hallucinations or active or treated Psychosis
* Patients with any other neurological / psychological disorder
* Patients who had received Central Nervous System (CNS) active therapy (e.g. sedatives, hypnotics, anti-depressants, anxiolytics, atypical neuroleptics, etc)
A Clinical Registry to Track the Real World Use of the Saber-C® Cervical Fusion Device

The objective of this registry study is to collect radiographic and clinical outcome measures to determine the effectiveness of the Saber-C device.

The purpose of this Clinical Registry is to track the real world use the Saber-C cervical fusion device when used for the treatment of Cervical Degenerative Disc Disease from C-2 to T1 for Anterior Cervical Discectomy and Fusion (ACDF). The registry is intended to profile the use of the Saber-C cervical fusion device when used according to surgeon standard of care at clinical practices throughout the United States. The focus of the registry will be to track and better understand the safety, effectiveness and market value of the Saber-C cervical fusion device.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Planned treatment with the Saber-C implant
* Subject is willing and able to sign informed consent

Exclusion Criteria:

* Subject is pregnant
* Subject is a prisoner
Views on Sharing Family Medical History in Healthy Women Undergoing Mammograms or Breast Evaluation

RATIONALE: Learning about the concerns that individuals may have about providing family medical history online for genetic risk assessment or research may help doctors plan future research.

PURPOSE: This clinical trial is studying views on sharing family medical history in healthy women undergoing mammograms or breast evaluation.

OBJECTIVES:

* To gain an initial understanding of the ethical, family, and related concerns that individuals may have when offered the option of providing family medical history online for genetic risk assessment or research.
* To identify specific directions for future research into the ethics of online genetic risk assessment.

OUTLINE: Participants undergo a 45-60 minute interview to assess their attitudes and concerns about providing family medical history online for genetic risk assessment or research. Participants' feelings about whether or not to use an online genetic assessment tool (i.e., Genetic Risk Easy Assessment Tool \[GREAT\]) are explored. The GREAT allows for the electronic creation, analysis, and dissemination of family histories of individuals who may be at risk for various types of cancer. Key factors influencing a participant's use of the tool, including concerns about confidentiality, privacy, informed consent, access to risk information, and security of online family history databases, are explored. Ethical issues regarding communication and agreement among family members on disclosing family medical history are also discussed.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Healthy women undergoing mammograms or being evaluated for a breast concern at the University Hospitals Breast Center

PATIENT CHARACTERISTICS:

* Able to speak English

PRIOR CONCURRENT THERAPY:

* Not specified
Nutritional Programme for Dementia Elderly Patient

The main objective of this study is the improvement of the quality of life and state of health of elderly people with cognitive deterioration and their families through a weight loss prevention programme.

The secondary objectives are the improvement of the state of nutrition, a reduction in the use of resources and a reduction in the burden on the main carer.

Main objective The main objective of this project is the evaluation of the effectiveness of a nutrition programme in patients with Alzheimer's or other dementias. Through the Nutrition Programme the idea is to reduce functional and weight loss in elderly people with cognitive deterioration and their families.

Evaluation of the effectiveness of the intervention

-The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale.

Secondary objectives

The secondary objectives of this study are:

* Improvement in the patient's state of nutrition The measurement criteria which will allow the patient's nutritional state to be evaluated will be their weight, BMI and MNA.
* Reducing the burden on carers. The Zarit scale will be used for this evaluation.
* Evaluation of the use of healthcare and social resources. The RUD scale will be used.
* Improvement of medical practice regarding nutrition.
* Evaluation of the representatives of our population with regard to the participation in a programme of these characteristics evaluating.
* Evaluation of the satisfaction of elderly people and their families in relation to the programme.

Eligibility Criteria:
Inclusion Criteria:

* The patient has dementia according to DSM IV criteria.
* The patient has an MMSE less than or equal to 26.
* The patient lives in his/her home.
* The patient is in the charge of a carer.
* Informed consent for participation in the study by the responsible relative and, if possible, from the patient or legal guardian.

Exclusion Criteria:

* The patient lives in an institution.
* The patient is in a terminal situation.
* The patient does not have a main carer.
* Patient has a nasogastric feed.
Tolerance and Digestibility of a New Formula in Healthy Infants

The great majority of infants formula contain fats exclusively from vegetable oil. Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an infant formula closer to the nutritional composition of maternal milk.


Eligibility Criteria:
Inclusion Criteria:

* normal growth;
* considered as healthy by the investigator according to the medical interrogation and the clinical examination;
* receiving exclusively infant formula for at least 15 days.
* without any solid food during the month of the study

Exclusion Criteria:

* Premature born children or small born weights;
* Children breast-fed or weaned for less than 15 days;
* Children with solid food
* Food allergy, particularly in milk proteins allergy , and lactose intolerance ;
* Tumoral, inflammatory, cardiac, lung, renal, digestive diseases(syndrome of malabsorption);
* Digestive pathology previous to the inclusion, in particular infectious (rotavirus, gastroenteritis) or functional symptoms (important stomach pains, colicky) having required a lot of change in formula quality;
* Children under medical treatment (ex: paracetamol).