cyrilzakka/clinical-trials huggingface dataset:
Basal Insulin for Type 2 Diabetes Patients Treated in Outpatient Clalit Clinics

Treatment of diabetes mellitus type II with basal insulin, for patients treated in Clalit outpatient clinics that are not adequately controlled with current treatment.

Patients with diabetes treated in outpatient clinics will be recruited by their primary care physician. Recruitment period will be 3 months per center and each patient will be followed for 7 months Diabetes specialists will be responsible for 50-65 primary care physicians. The specialists will advise and direct the primary care physician through the whole study period.

The study protocol includes patients treated with different types of non short- acting insulin. Insulin Lantus (including dose) will be started by the primary physician, if needed after consulting the Diabetes Specialist. The treatment should follow the study protocol.

Patients will have 3 pre-scheduled visits in their clinic: 1. At the beginning of study. 2. After 3 months. 3. At study end (after 6 month). An additional telephone contact will take place 1 month after last visit. to evaluate adherence to therapy Data collecting: Data including HbA1c, FPG,current diabetic treatment, dose of insulin Lantus, and relevant additional diseases\\complaints will be collected at each visit. Additional information as demographic data, medical history will be collected at beginning of study.

Safety: Hypoglycaemic episodes will be recorded

Eligibility Criteria:
Inclusion Criteria:

1. Type II Diabetic patients
2. HbA1c \>8.0% (result from preceding 4 months)
3. Written informed consent
4. Life expectancy of at least 1 year.
5. Patients' agree to discontinue current long acting insulin (if applicable).
6. Patients who according to their GP are eligible to the study.

Exclusion Criteria:

1. Type I diabetes
2. Pregnancy and\\or lactation.
3. Allergy to basal insulin
4. Patients suffering from a disease that requires repeated hospitalizations E.g.: severe CHF, sever renal failure, active malignancy.
5. Patients who are not able to give consent.
6. Patients face difficulties in mobility and/or verbal communication with the treating physician.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Follicular Fluid, Bioavailable Vitamin D and Embryo Quality Markers

To determine the correlation between bioavailable Vitamin D values and euploid status of the embryos in larger size follicles from UAE women undergoing in vitro fertilization procedures.

To study the possible correlation between bioavailable vitamin D values in follicular fluid and embryo quality markers.

To correlate bioavailable Vitamin D values in follicular fluid from large size follicles with embryo euploid status as our main objective. Secondly, looking at morphokinetics and mitochondrial content of these embryos.

Taking into account that most of UAE patients have deficiency or insufficiency of Vitamin D, if there is a correlation found we will understand better the underlying mechanism by which bioavailable Vitamin D levels may be affecting embryo quality, therefore IVF outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Women´s Age \>18 - ≤43 years.
* BMI 19-33
* Male partner will produce fresh sperm sample on the same day of the egg collection procedure.
* Women with more than 10 follicles at the time of the trigger
* At the time of egg retrieval, at least three follicles between 14-\<17 mm and three follicles ≥17 mm.
* Women ≤35 years old stimulation with rFSH antagonist
* Women ≥36 years old stimulation with highly-purified human menopausal gonadotropins (hpHMG) specifically for the additional LH.
* Middle East population

Exclusion Criteria:

* Polycystic ovarian syndrome (according to the Rotterdam Criteria).
* Patients at risk of OHSS, according to the criteria previously described by Papanikolau et al. (23).
* History of endometriosis, classified according to the American Fertility Society (AFS) as stage 3 or more.
* Severe male factor definition (\<2 million of sperm per ml of ejaculate)
* Recurrent miscarriage (3 miscarriages)
* Smokers
* History of chemotherapy or radiotherapy
Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience

The objective of this study is to confirm procedural performance of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures.

The main objective of this study to confirm the design and operating specifications of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures in study subjects.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
* Scheduled for a clinically indicated endoscopic retrograde cholangiopancreatography (ERCP)

Exclusion Criteria:

* Altered pancreaticobiliary anatomy
* Potentially vulnerable subjects, including, but not limited to pregnant women
* Subjects for whom endoscopic techniques are contraindicated
* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
* Investigator discretion
Exercise and Socialization in Post-partum Depression

This community-engaged research project aims to address the critical need for alternative treatments of post-partum depression (PPD). The goal of this research is to investigate the efficacy of a novel 8-week intervention combing exercise with social support to reduce PPD symptoms. It is hypothesized that exercise in addition to social support will more effectively reduce PPD symptom severity compared to social support alone. By collaborating with PPD mothers, clinicians, researchers, and local fitness instructors, the researchers aim to develop an intervention that is accessible, culturally appropriate, effective, and increases treatment adherence. Additionally, the researchers will investigate if mother-infant interactions during exercise can enhance bonding, thereby reducing the detrimental effects of maternal PPD on their off-spring.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18 years old
* Two-weeks to 12 months post-partum
* EPDS over 10
* Read and Speak English
* Willing to supply contact information for their clinician and consent to their clinician being contacted in the event their depression worsens.

Exclusion Criteria:

* Use of anti-depression medication(s) at time of enrollment
* Unable to give consent
* Prisoner, parolee, state probationer, or awaiting sentence for a felony conviction
The Effects of Aldara as an Adjunct to Laser Treatment

The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.

This is a randomized, controlled, double-blinded study. Volunteers who are scheduled for laser treatment of Port Wine Stains will be screened and eligible subjects will be asked to participate. The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient between the ages of 2 and 60 years with a vascular malformation that is seeking cosmetic treatment.
* All races will be included as well as male and female.
* Clinical data on the usage of Aldara below the age of 2 years is limited and therefore all patients in the study will have to be at least 2 years of age.
* The majority of port wine stains are initially treated during childhood
* In order to determine the effectiveness of Aldara as an adjunct to laser therapy of Port Wine Stains, some of the patients in the study need to have lesions that have not undergone previous treatment.

Exclusion Criteria:

* Patients under the age of 2 or over the age of 60.
* Patients that have serious medical problems that would put them at risk of the anesthesia.
* Patients that have sensitivity reactions to the ingredients in the product including imiquimod, isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.
* Patients who are pregnant or have significant immunodeficiency or autoimmune diseases.
Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B

This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18\~65 years.
* Serum HBsAg or HBV DNA positive for at least 6 months.
* Serum HBsAg and HBeAg are both positive, HBV DNA ≥ 20,000IU/ml at screening.
* 2×ULN≤ ALT ≤10×ULN at screening (ULN=upper limit of normal).
* Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the treatment.

Exclusion Criteria:

* Pregnant or lactating women.
* Mental disorder or physical disability.
* Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
* ANC \< 1500/mm3, or PLT \< 90,000/mm3.
* Co-infection with HAV, HIV, HCV, HDV, or HEV.
* Both of HBsAg and anti-HBs are positive, or both of HBeAg and anti-HBe are positive at screening.
* Child-Pugh ≥ B, or other evidence of hepatitis decompensation (e.g.: prothrombin time prolonged more than 3 seconds, TBil \> 2ULN, Alb\<35g/L).
* Chronic hepatitis caused by any other reason except hepatitis B.
* Hepatocarcinoma or suffering from any other malignant tumor.
* Not well-controlled endocrine diseases (e.g.: thyroid dysfunction, diabetes mellitus)
* Significant function damage in any major organs (e.g.: heart, lung, kidney).
* Other Conditions which in the opinion of the investigator precluding enrollment into the study (e.g.: poor compliance).
Assessment of Oral Health Status of Patients in Pediatric Intensive Care Units

The research is a descriptive study designed to evaluate the oral health status of hospitalized children in pediatric intensive care units. The research was conducted between June 2021 and September 2021 in pediatric intensive care units in Izmir province. The patients were included in the study by using the cluster sampling method in the selection of the sample (n=88). Patient Identification Information Form and Oral Assessment Guide (OAG) were used for oral health assessment of patients. It was taken written consents from the hospitals where the research was carried out and from the relatives of the patients


Eligibility Criteria:
Inclusion Criteria:

* Being treated in the PICU
* Parent's consent to participate in the study

Exclusion Criteria:

* Applying non-invasive ventilation therapy
The Effect of Kinesio Taping on Posture in Healthy Young Adults

Healthy young adults who are health care workers at Haydarpasa Numune Training and Research Hospital will be included in the study considering the inclusion and exclusion criteria. Demographic data such as age, gender, height, weight will be recorded. Thoracic kyphosis and lumbar lordosis angles of the participants will be recorded with Goniometer pro application at the beginning. Spinal muscle thickness including the back extensor muscle group will be measured from the thoracic and lumbar regions with ultrasound by a specialist with clinical experience for ultrasound. Measurement will be made at T8 level for thoracic region and L3 level for lumbar region. They will be evaluated with the Nottingham health profile.

A total of 78 people will be included in the study and will be randomly divided into two groups as intervention + exercise and exercise only group. Randomization will be done by closed envelope method. Kinesiobanting will be applied to the intervention group for 4 weeks, with the posture correction technique on Mondays, and the kinesiobant application will be applied once a week for 4 sessions in total, to be removed on Friday. Both groups will be given a 40-minute posture exercise program based on clinical experience, to be performed every other day, i.e. 4 times a week for 12 weeks. Patients will be given an exercise follow-up chart and will be called once a week and followed up for 12 weeks. In the intervention group, thoracic kyphosis and lumbar lordosis angle measurements with Goniometer pro application will be examined at 30.minute at baseline, Week 4 and Week 12, while in the exercise only group they will be examined at baseline, Week 4 and Week 12. Ultrasound measurement of spinal muscle thickness will be performed at baseline and at Week 12 in both groups. Nottingham Health Profile will be performed at baseline, Week 4 and Week 12 in both groups. Differences within and between groups will be analyzed statistically.


Eligibility Criteria:
Inclusion Criteria:

* Health workers
* Over 18 and under 40
* Visual analog scale (VAS) \< 4 for muscle pain
* Inactive (category 1) and minimally active (category 2) according to the international physical activity survey
* Healthcare workers without cognitive deficits who can take verbal instructions

Exclusion Criteria:

* Diagnosed disc herniation with or without spinal deformity
* Bone abnormality and peripheral symptoms
* Infectious or inflammatory arthropathies
* History of joint replacement surgery,
* History of spinal surgery
* Need for assistive devices for ambulation
* irregular hypertension
* Uncontrolled diabetes mellitus
* Presence of neurological disease
* History of malignancy
* Uncontrolled cardiopulmonary disease
* Pregnancy
* Morbid obesity (Body mass index \> 35)
* Having fibromyalgia syndrome
Project INSPIRE: INtervention Support Groups: Peers Inspiring Resilience and Empowerment

The investigators will develop a new, integrated, group intervention to enhance safety, support, and empowerment for survivors of intimate partner violence in the community. The intervention will consist of 9 weekly, 90-minute group sessions that will teach specific skills for identifying various forms of trauma and abuse, developing mutually supportive relationships, safety planning and self-care, goal-oriented communication, empowerment and self-efficacy, goal setting, coping, and connecting to resources. The investigators will pilot test the intervention, including evaluating the process of implementation, including feasibility, acceptability/likeability, and safety, as well as evaluating outcomes of safety, support, and empowerment. Outcomes from the intervention will be compared to outcomes from a traditional domestic violence support group.


Eligibility Criteria:
Inclusion Criteria:

* Domestic Violence Service Provider client referred for support group services

Exclusion Criteria:

* Unable to provide informed consent
Shaping Anesthetic Techniques to Reduce Post-operative Delirium

The purpose of this study is to determine if light sedation with spinal anesthesia reduces the incidence of delirium compared to receiving general anesthesia during spinal surgery in older adults.

Post-operative delirium is a common occurrence in older adults. Post -operative delirium has been associated with cognitive decline after hospitalization. Developing perioperative management strategies to prevent delirium may also reduce potential cognitive decline in older adults after surgery. The choice and dose of anesthetic and sedative drugs are known risk factors in the development of delirium. Excessive doses of anesthetic and sedation drugs during surgery have been associated with poor outcomes that occur after surgery. Currently depth of anesthesia can be measured by an additional monitoring technique called Bispectral Index (BIS).

The purpose of this study is to determine if light sedation with spinal anesthesia reduces the incidence of delirium compared to receiving general anesthesia during spinal surgery in older adults. Previous studies have shown that using light sedation and spinal anesthesia during surgery may reduce the incidence of delirium up to 50%.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients age 65 and over.
* Patients undergoing lumbar fusion performed by Dr. Charles Edwards II, Dr. Charles Edwards, Dr. Clayton Dean , or Dr. Justin Park at Mercy Medical Center.
* Expected length of surgery \<3 hours.
* Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

* Contradictions to spinal anesthesia (severe aortic stenosis, anti-coagulant or antiplatelet medications, other)
* Body mass index \> 40 kg/m2
* prior lumbar fusion from L2-L5 in entirety
* Communication issues precluding delirium assessment or sedation
* Dementia or mini-mental status exam score \< 24
* Psychiatric disease that would preclude cooperation with sedation with spinal anesthesia
* Any other reason that the attending anesthesiologist or surgeon feels that clinical circumstances dictate a strong preference for either spinal or general anesthesia.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment

The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind, parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.


Eligibility Criteria:
Inclusion Criteria:

* male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia
* experiencing an acute exacerbation of psychosis

Exclusion Criteria:

* any subject unable to provide informed consent
* any female subject who is pregnant or breast-feeding
* any subject judged to be medically inappropriate for study participation
Tablet-based Patient Reported Outcome

This study is a single arm feasibility study. Patients that have been diagnosed with carcinoma and are undergoing chemotherapy have to document chemotherapy associated side effects on a regular basis by means of a tablet-based online questionnaire. Goal of the study is to find out if patients that are undergoing chemotherapy are willing to document chemotherapy associated side effects by means of a tablet-based online questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* patients have to be ≥ 18 years of age
* written consent form and agreement to participate in the study
* patients that are able to follow the study instructions and that most likely will keep the required study appointments
* patients that have a histological confirmed carcinoma and are scheduled to undergo adjuvant or neoadjuvant chemotherapy of 6 to 8 cycles
* questions about chemotherapy associated side effects are composed in german. Therefore the study participants must have sufficient knowledge of the german language
* ECOG maximal level 2

Exclusion Criteria:

* patients that are younger than 18 years
* patients that don't agree to take part of the study
* patients that are not able to understand the scope, the meaning and the consequences of that clinical study
* patients that have a known or constant addiction to drugs or alcohol
* patients that suffer from blindness or dyslexia
A Study to Examine Levels of Sedation During Outpatient Colonoscopies

Examine levels of sedation required for patients to comfortably undergo colonoscopy using propofol and if adjunct monitoring equipment promotes patient safety.

Propofol for sedation during outpatient endoscopy has become a popular technique in place of midazolam and opioid sedation. It has been associated with improved patient satisfaction and a faster recovery with less nausea and vomiting. However, there are a number of potential adverse effects associated with propofol. It has no analgesic effects; therefore, when used for moderate sedation procedures it frequently has to provide deeper levels of sedation to allow a painful procedure to be performed.

Some patients are sedated to the level of general anesthesia and may develop respiratory depression or airway obstruction requiring immediate airway support.

We examined the level of sedation required for patients to comfortably undergo routine colonoscopy using propofol and what monitoring system would best predict the patients who might need an airway intervention.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* ASA classification of I, II, or III

Exclusion Criteria:

* Anesthesiologist plans to use a combination of medications other than propofol for sedation.
* ASA classification IV or higher
* Lesions on forehead or earlobes
Prospective Study of Children and Adolescents With Craniopharyngioma

The present investigation is a prospective, multicenter study evaluating craniopharyngioma patients' prognoses following the various currently-practiced therapeutic strategies.Primary goals of the study are to establish quality standards and compare the various therapy strategies with respect to their effectiveness and impact on the quality of life of treated patients. A stratified randomization of two treatment arms will be conducted with respect to timing of postoperative irradiation for the subgroup of patients ≥5 years of age whose tumors are incompletely resected. The researchers will investigate whether an immediate, postoperative irradiation is superior to progression-contingent irradiation based on alterations to quality of life (PEDQOL) from the time randomization is initiated (3rd month post op) to 3 years after randomization. Progression-free survival and overall survival will be examined as closely-related subgoals.Postoperative data will be evaluated via a surveillance study for all complete resection patients as well as for those patients under 5 years of age regardless of their resection grade.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with craniopharyngioma for the first time
2. Age at diagnosis 18 years or less of age
3. Agreement from patient's parents or legal guardian as well as the patient

Criteria for inclusion in randomization study

1. Histological diagnosis of craniopharyngioma
2. Age at diagnosis 18 years or less of age
3. Age at primary surgery over 5 years of age
4. Incomplete primary resection
5. Reference radiological confirmation of an incomplete resection
6. Agreement from patient's parents or legal guardian as well as the patient

Exclusion Criteria:

Age at diagnosis over 18 years of age No QoL measurement for randomization (3 months after surgery).