cyrilzakka/clinical-trials huggingface dataset:
The Management of Schizophrenia in Clinical Practice (MOSAIC)

This study is a disease-based registry designed to follow patients with a DSM-IV-TR (Diagnostic and Statistic Manual of Mental Disorders, Text Revision) diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder treated in usual care settings for up to 5 years. The registry seeks to describe the course of disease in schizophrenia, including cognitive function and negative symptoms, its treatment, and its burden of disease for participants, caregivers, clinicians, and society as a whole.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder
* Participants presenting with the normal course of care in usual treatment settings
* Able to read and speak English
* Able and willing to provide informed consent
* Able and willing to comply with the study protocol

Exclusion Criteria:

* Participants enrolled as subjects in clinical trials at registry enrollment
* Participants anticipating they will be unable to participate in regularly scheduled assessments as per protocol
A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis

The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic erosive gastritis and its therapeutic mechanism


Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years old
2. Have been diagnosed as chronic non-atrophic erosive gastritis by endoscopy within 1 weeks before enrollment, and the modified Lanza score ≥ 2
3. Have at least two symptoms in four major symptoms (epigastric pain, epigastric burning, early satiety, belching) and total symptom score ≥ 4 (Rome Ⅲ for Functional Gastrointestinal Disorders)

Exclusion Criteria:

1. Suspected upper gastrointestinal malignancy by endoscopy
2. Peptic ulcer and bleeding by endoscopy
3. Severe cardiac, hepatic or renal insufficiency
4. Severe neurological or psychological disease
5. Pregnant or lactating women
6. Have taken drugs which may affect evaluating the efficacy of study drug within two weeks before enrollment (includes but not limits to: Proton pump inhibitors such as omeprazole, rabeprazole, pantoprazole, lansoprazole, esomeprazole, H2 receptor antagonists such as cimetidine, ranitidine, famotidine, antacids such as calcium carbonate, gastric mucosal protectants such as colloidal bismuth potassium citrate and other bismuth products, sucralfate, aluminum phosphate, teprenone, gefarnate, aluminum magnesium carbonate, glutamine, rebamipide, ecabet, misoprostol, antibiotics such as amoxicillin, clarithromycin, tetracycline, ofloxacin, levofloxacin, furazolidone, metronidazole, tinidazole, Non-Steroid Anti-Inflammatory Drugs such as aspirin, ibuprofen, loxoprofen, naproxen, diclofenac, indomethacin, meloxicam, acetaminophen)
7. History of allergic reaction to the medications used in this study
8. Patients that investigators consider ineligible for this study
Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer

The purpose of the study is to investigate the feasibility of a preoperative, single dose, ablative partial breast radiation treatment in patients with early-stage breast cancer.

A total of twenty-five patients will be treated with a single dose preoperative ablative radiation treatment. After a vigilant follow-up with MRI, breast conserving surgery will be performed 6 months after the ablative radiation treatment. The total follow-up time is 10 years.

This study aims to present an ablative radiotherapy treatment approach that could resolve to some extent the disadvantages of current breast conserving treatment in elderly low-risk breast cancer patients who are currently not treated according to guidelines due to co-morbidity.

Eligibility Criteria:
Inclusion Criteria:

* WHO performance scale ≤2.
* Females at least 50 years of age with unifocal cT1N0 breast cancer or females at least 70 years of age with an unifocal cT1-2(maximum 3 cm)N0 breast cancer:

  - Tumor size as assessed on MRI
* On tumor biopsy:

  * Non-lobular invasive histological type carcinoma.
  * LCIS is accepted.
  * ER positive tumor receptor.
* Tumor negative sentinel node.
* Adequate communication and understanding skills of the Dutch language.

Exclusion Criteria:

* Legal incapacity
* Indication for chemotherapy or immunotherapy (i.e. patients with an indication for endocrine therapy are eligible)
* BRCA gene mutation.
* Previous history of breast cancer
* Other type of malignancy within 5 years before breast cancer diagnosis. For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span from breast cancer diagnosis is required for inclusion
* Her2neu positive tumor.
* Previous history of ipsilateral breast surgery and impaired cosmetic outcome, as assessed by the treating surgeon or radiation-oncologist.
* Collagen synthesis disease.
* Signs of extensive DCIS component on histological biopsy or mammogram.
* Invasive lobular carcinoma.
* MRI absolute contraindications as defined by the Radiology Department.
* Nodal involvement with cytological or histological confirmation.
* Treatment with neo-adjuvant systemic therapy.
My Life and My Experiences Project

Child maltreatment is one of the most formidable public health crises in the United States, affecting millions of youth each year. The adverse consequences of maltreatment for youth, as well as for their families and entire communities, are pervasive, costly, and enduring. To intervene and reduce these consequences, it is imperative that victims provide clear and accurate accounts of their prior experiences. Currently, considerable skepticism exists regarding maltreated youth's ability to provide such accounts, especially for experiences that were stressful, leading to youths' reports being challenged or not believed. It is possible that this skepticism is unwarranted, and maltreated youth actually demonstrate better memory than their non-maltreated counterparts, but only for stressful salient personal experiences. This project will ethically and rigorously test this possibility via a short-term longitudinal experimental investigation that compares the effects of acute stress on memory between maltreated and demographically matched non-maltreated 12-17-year-olds. In an initial in-person session, youth will be randomly assigned (equal maltreated and non-maltreated youth across age) to complete standardized salient personal activities that are experimentally manipulated to vary in whether they induce higher or lower levels of acute stress. Immediately afterward, youth will complete an encoding task comprised of positive, negative, and neutral images. In subsequent sessions (two remote and one in person) spanning approximately one month, youth's memory will be tested for the images via a recognition task asking them to discriminate previously seen from unseen images and for the personal activities via recall and direct questions that probe for the extent and accuracy of memory. Youth's rumination about the personal activities will also be measured. The project's main hypothesis is that maltreatment will lead to particularly robust memory for the personal activities, but only when the youth complete these under conditions of high stress. By contrast, because the emotional and neutral images are not personally meaningful, maltreatment is expected to constrain youth's memory performance for the images. It is also hypothesized that rumination will serve as an important mediator of the links between stress and memory for the higher stress personal activities, most notably in the maltreated youth. Overall, the project's results will provide much-needed knowledge about the precise ways that maltreatment shapes different facets of youth's memory, knowledge. This knowledge will be enormously valuable in improving trust in maltreated youth's reporting of stressful experiences and hence in directing interventions for victimized youth.


Eligibility Criteria:
Inclusion Criteria:

Ages 12-17 at start, half self reported or documented prior contact with social services/dependency court; half always lived with at least one biological parent

Exclusion Criteria:

Public speaking or math anxiety, cognitive impairments, head injuries, learning disabilities, steroid/hormonal treatments, or neuroendocrine diseases
Assessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request

The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request. The aim is to improve the quality of sexual life of these patients.

Breast cancer and its treatment are responsible for symptoms that can persist over time and affect quality of life. Given the improved prognosis for breast cancer, more and more patients are faced with the specific problems of the post-cancer period, and caring for them has become a major health issue. Sexual health is a crucial component of well-being and overall quality of life.

The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request.

For that, quality of life questionnaires will be completed by patients at inclusion and every 6 months for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Woman or man at least 18 years old
* Diagnosis of infiltrating breast cancer regardless of the biological characteristics of the tumor
* Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago with the exception of post-neoadjuvant treatments (chemotherapy, poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously
* Patient with sufficient command of the French language to be able to answer the questionnaires
* Patient having given informed, written and express consent.
* Affiliation to the French Social Security System
* Willingness and ability to comply with scheduled visits, treatment plan and other study procedures

Exclusion Criteria:

* Patient already taken cared of in oncosexology. The following are not criteria for non-inclusion (a previous single consultation without treatment, use of local vaginal treatments)
* Metastatic disease
* Patient under guardianship, curatorship or safeguard of justice
Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid

This project will develop and test quality measures for and a facilitation model to help addictions treatment clinics increase use of medicines for opioid use disorders, retain clients longer in care, and help more people move into successful recovery. At the end of the project, we will have developed specific training and coaching protocols as well as electronic clinical support tools to guide quality improvement that can be disseminated within New York and the rest of the country.

The study will test a clinic-level intervention that uses external facilitators to provide guidance to addictions clinics and contain three key components: 1) training on data driven management; 2) training and guidance on patient-centered care and OUD medication; and 3) electronic tools for shared decision making and patient progress monitoring.

There will be 4 sources of data examined in this study: 3 at the patient level and 1 at the staff level. The sources of patient data include: 1) State administrative data from all clients receiving treatment at the enrolled clinics (\~7,950); 2) a subsample (1,200) who will be recruited directly from the clinics to complete patient-reported outcome assessments, and 3) treatment progress data for clients will also be collected.

For our administrative source of data, a final study population of approximately 7,950 individuals who are receiving treatment in the 30 enrolled outpatient treatment clinics for OUD is anticipated. Clinics will be located in the New York City metropolitan region (including Nassau, Westchester, and Rockland counties) and the Capital Region (including Albany, Rensselaer, Saratoga, Montgomery, Schenectady, and Schoharie counties). Staff at each enrolled clinic will also be interviewed and surveyed.

Eligibility Criteria:
Inclusion Criteria:

* Substance use disorder clinics in the regions surrounding New York City and the New York Capital Region with annual census of 50 or greater.
* All staff and patients from participating clinics will be eligible to participate in the study.
* Inclusion in the analyses using administrative data will be limited to those enrolled in Medicaid and not co-insured with Medicare (individuals ages greater than 64 and those with Federally determined disability).

Exclusion Criteria:

* Patients who are not working/being treated at substance use disorder clinics with less than 50 clients per year.
Effect of Sleep Extension on Overweight and Learning in Children

More2Sleep is a randomized, controlled, parallel trial with two groups (sleep extension vs control) including 300 school-aged children (6-9 years) who are mildly overweight or obese and habitually sleep for ≤ 9 h/night. Data will be collected before and after a 3-month sleep extension intervention, and after a 6-month follow-up (at months 0, 3, and 9). The collection of data is mainly related to the main study. However, some optional examinations will be conducted on a first come, first serve basis, consisting of substudy-I (metabolic mechanisms, n=60) and substudy-II (learning mechanisms, n=150).

The primary objective is to assess the effects of sleep extension by \~45 min/night, achieved by going to bed 60-90 min earlier, on adiposity and learning ability in school-aged children who are overweight or obese, and sleep less than recommended for their age.


Eligibility Criteria:
Inclusion Criteria:

* Age: 6-9 years old (inclusive range).
* Weight status: modestly overweight or obese (equivalent adult BMI of 25 to 35 kg/m2) defined as a sex-specific BMI Z-score between +1 and +3 (inclusive range) using reference standards from the World Health Organization.
* Sleep duration: sleeping ≤9 h/night on the basis of sleep diaries filled in by the children's parents, based on recommendations by the American Academy of Sleep Medicine and the Sleep Health Foundation.

Exclusion Criteria:

* Any genetic or chronic condition that affects growth, metabolism, eating behaviors, cognitive function, or body weight (for example: dwarfism, epilepsy, attention deficit hyperactivity disorder, β-thalassemia, hypo-/hyper-thyroidism, type I diabetes).
* Any sleep-related disorder (for example: obstructive sleep apnea, parasomnias, narcolepsy, restless leg syndrome).
* Regular use of prescribed or over-the-counter medications that influence study out-comes.
* Irregular school schedule or not consistently sleeping in the same household during the school week.
* Participation in other research studies.
Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome

This is an extension study that will gather long-term data on the effect of early growth hormone (GH) treatment on adult height and other aspects of health and development in girls with Turner syndrome. The main purpose is to determine whether girls who received 2 years of GH treatment before 6 years of age achieve taller adult height than girls who were untreated during this time. The study will also look at middle ear and hearing function, and cognitive and behavioral development. Protocol completion is defined as attainment of height velocity less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.


Eligibility Criteria:
Inclusion Criteria:

* Previously randomized in study B9R-US-GDFG (NCT00406926)
* Karyotype-proven Turner syndrome

Exclusion Criteria:

* Immediate family members of study site personnel directly affiliated with the study
Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus

The purpose of this study is to determine the effects of cinnamon on serum glucose and lipid levels in people with non-insulin dependent type 2 diabetes mellitus.

Forty people with non-insulin dependent type 2 diabetes mellitus will be randomized to receive either cinnamon or placebo for three months. The dose of cinnamon will be one gram daily. Fasting serum glucose, triglyceride, total cholesterol, LDL, HDL, and insulin levels will be measured at baseline and at 1, 2, and 3 months. HbA1c levels will be measured at baseline and at 3 months. Patients will be monitored for compliance, adverse effects, and dietary changes.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* HbA1C \> 6.0%
* Age 18 and above
* Able to obtain consent

Exclusion Criteria:

* Currently taking insulin
* Pregnancy
* End-stage renal disease
* Hemolytic anemia
* Cinnamon intolerance
* Inability or unwillingness to adhere to study protocol
Efficacy of Hypnotherapy for Agoraphobia

The purpose of the study is to compare the efficacy of Hypnotherapy for the treatment of Agoraphobia compared to a wait-list control group.

With the present study, the efficacy of 8-12 sessions of individual Hypnotherapy will be compared to a wait-list control groups. At study entry and at the end of treatment with Hypnotherapy, the Agoraphobia symptoms will be assessed via clinician-rating and self-report. It is expected that Hypnotherapy will be superior to a wait-list control regarding the percentage reduction of the anxiety symptoms after three months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Patient fulfills DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria for agoraphobia
* 18 - 65 years of age
* Sufficient knowledge of the German language in order to participate in the study
* Sufficient availability to participate in weekly therapy sessions

Exclusion Criteria:

* Acute suicidality (intended action, concrete plans or intermittent pronounced suicidal ideation)
* Lifetime diagnosis of a bipolar disorder or psychotic disorder
* Alcohol or substance use disorder without abstinence in the last 12 months
* Severe cognitive impairments (in cases of suspicion evaluation via Mini Mental State Test (MMST) \< 26, will be conducted)
* Other severe primary mental disorders to be treated: severe Major Depressive Disorder, severe personality disorder of borderline type with self-injury, severe combined personality disorder, actual posttraumatic stress disorder, anorexia nervosa, obsessive compulsive disorder
* Somatic disorder impeding participation in regular psychotherapy sessions
* Outpatient psychotherapy during the last twelve months.
* Medication with anxiolytics or anti-psychotics (antidepressant medication is permitted if stable since more than eight weeks and no planned changes during the duration of therapy)
Longitudinal MRI Assessment in Patients With Diffuse Low-grade Gliomas

Retrospective longitudinal follow-up in patients with diffuse low-grade glioma with multimodal MRI assessment


Eligibility Criteria:
Inclusion criteria:

* Initial WHO grade II
* At least 3 exploitable MRI each including a morphologic FLAIR sequence and perfusion imaging

Exclusion criteria:

-Major protected person ( trusteeship, curatorship, justice safeguard)
Telecare in Type 1 Diabetes (T1D) Patients Treated by Insulin Pump

The purpose of this study is to determine whether Telecare can be used for efficient management of adults with Type 1 Diabetes Mellitus using insulin pump, in lieu of frequent clinic visits.

1. Objectives

   1. To evaluate the effect of telecare on glycemic control for patients with type 1 diabetes (T1DM).
   2. To assess the cost of telecare to Maccabi, the patient and the economy.
   3. To assess patients' quality of life and satisfaction with telecare intervention.
   4. To assess the effect of telecare intervention on insulin adjustment to consumed carbohydrates.
2. Working hypothesis Telecare can be used for efficient management of T1DM in adults using insulin pump, in lieu of frequent clinic visits.
3. Methodology A randomized controlled prospective trial for one year. Intervention group: Each patient will transmit glucometer and pump data electronically via a web site (Medtronic Carelink internet site www.carelink.minimed.com) to diabetes team and will receive feedback by telephone. Frequency of data transfer will be directly related to patients' metabolic control. In addition to data transmission Patient of the intervention group will be arriving during the intervention year for 3 clinic visit at the following time point : 0, 6 and 12 month.

   Control group: 3-month routine clinic visits
4. Significance of the proposed research (its uniqueness and innovation) Telecare potentially offers a method for efficient continuous care management of patients with T1DM using insulin pump in lieu of clinic visits. It enables real time responses of clinical personnel and increases patient involvement. This trial will be the first telecare intervention lasting for one year to determine if treatment is as efficient as face to face visits, thus enabling cost reduction and time saving without affecting the quality of care. .

Eligibility Criteria:
Inclusion Criteria:

* Patients with T1D lasted \>1 year, age 22 and up, using insulin pump
* Patients possessing a mobile phone and internet access

Exclusion Criteria:

* Patients with Severe target organ damage
* Patients with Mental retardation
* Patients with Eating disorders
* Pregnant patients or patients planning pregnancy
Alveolar Ridge and Soft Tissue Augmentation Using Graft From the Maxillary Tuberosity

In the study immediate implant is placed in the anterior region with autogenous bone grafting from the maxillary tuberosity in one group and in the other group immediate implant is placed with xenograft .IN both groups soft tissue grafting is done using connective tissue assessment of buccal bone thickness and soft tissue will be done 6 months post operative

immediate implant will be placed in the anterior region with autogenous graft from the maxillary tuberosity and in the other group immediate implant will be laced with xenograft soft tissue grafting using sub-epithelial connective tissue will in both groups assessment of buccal bone thickness is the primary outcome of the study, while volumetric assessment of the soft tissue and patient satisfaction are the secondary and tertiary outcome the assessment of all outcome will be 6 months post operative the extraction socket in which the implant will be placed are class I\&II

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients (American Society of Anesthesiologists I; ASA I).
* Age range (20-40) years.
* Good compliance with the plaque control instructions following initial therapy.
* Patients diagnosed with bone defect in the maxillary anterior esthetic zone (class 1 \& 2)
* Availability for follow up and maintenance program.

Exclusion Criteria:

* Peri apically infected teeth
* Presence of smoking habit.
* Presence of occlusal interferences.
* Pregnant females.
* Vulnerable group of patients (handicapped, mentally retarded and prisoners) (according to the recommendation of esthetical committee of Faculty of Dentistry Ain Shams University).