cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Mobile App to Promote Social Support for Oncology Patients

Our study will evaluate patient and caregiver use of a new mobile application (app) to support patients undergoing chemotherapy treatment for cancer.

The app is designed to be used by the patient and members of their support network. It provides wide-ranging functionality, including: reminders for appointments and tasks, the ability to track health measures (fitness, emotion, pain, sleep), archive health related documents, maintain notes and recordings from visits, social networking functions to connect with family and friends to coordinate support activities and share news, and educational resources. We will randomize 230 patients initiating chemotherapy cancer treatment and up to one caregiver to the App group (asked to use the app once or more per week) or the Usual Care group, and evaluate the 3-month efficacy of app use on key outcomes.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Patients must have a confirmed diagnosis of cancer and be prior to or within one month of initiating chemotherapy or immunotherapy
* Have a valid email address
* Have a smart mobile device (Android or iOS) with a data plan
* Willing to download and use the study app

Exclusion Criteria:

* Unable to communicate in English.
Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants

This is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without HMOs).

This is a multi-center, open-label trial to be conducted in up to 70 pre-term infants in order to evaluate the safety and suitability of two feeding systems as they would typically be used in the neonatal care unit. Growth (in comparison to recommended growth goals), feeding tolerance, biochemical parameters, and adverse event reporting will be evaluated.

The two feeding systems will be tested in two sub-studies to be conducted sequentially: sub-study 1 will evaluate a two-staged feeding system with HMOs in up to 35 pre-term infants; sub-study 2 will evaluate a two-staged feeding system without HMOs in up to 35 pre-term infants.

A follow up period from 12 to 24 months have been added to the study protocol, to assess the neurocognitive development of the subjects during this period.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent has been obtained from one or both parent(s) /legally acceptable representative (LAR) in accordance with local regulation.
2. Infants' birth weight ≤1500 g and AGA.
3. Infant's gestational age \< 37 weeks.
4. Infant is clinically stable and does not have deteriorating respiratory function after birth.
5. Infant is eligible to start experimental formula after 24 hours of trophic feeding, but still within the first 10 days (≤240 hours) of life.

Exclusion Criteria:

1. Parent(s) not willing / not able to comply with the requirements of study protocol.
2. Infant is experiencing early onset sepsis.
3. Major congenital or chromosomal abnormality known to affect growth.
4. Liver failure.
5. Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification).
6. Infant who has siblings with diagnosed allergies or intolerances to lactose or cow's milk.
7. Infant's participation in another interventional clinical trial.
8. Infant has already achieved FEF prior to enrolment, using the definition accepted by Neonatal Unit as per standard practice (150 mL/kg/day).
Effect of Preoperative Education Based on Roy Adaptation Model

This research was conducted as a randomized controlled experiment to determine the effect of the education given by the Physiological Mode of Roy Adaptation Model in patients with hip or knee arthroplasty on physical adaptation and mobility.

The research was conducted between 01.11.2017 - 01.04.2018 at the Orthopedics and Traumatology Surgery Service of a private University Hospital in Istanbul.

In the study, the number of samples to be taken; the training, the training group control group mobility scale scores between The Observer at least 5% of the study considering that would make a difference, and power 80%, α=0.05 and power analysis adopted by participants for each group were calculated and it was determined that there should be at least 27.

The sample was composed of 78 individuals 41 experimental and 37 control. Patients' physical adaptation and mobility were evaluated using the Patient Mobility Scale and Observer Mobility Scale and Physical Adaptation Assessment Form.

Randomization of the study was achieved by planning patients who met the inclusion and non-inclusion criteria for training and control groups sequentially, without dividing them into hip or knee arthroplasty. In the randomization table, those with the number 1 are assigned to the training group.

Eligibility Criteria:
Inclusion Criteria:

can read and write in Turkish A sufficient level of education to understand study procedures and training

Exclusion Criteria:

hospitalized due to fracture mental disability neurological disease undergone the same operation before received similar training before
A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally in Subjects With Nonalcoholic Fatty Liver Disease

Potential subjects with non-alcoholic fatty liver disease (NAFLD) will be identified by gastroenterologists (study investigators). Twelve eligible subjects with NAFLD will be randomly assigned to receive either active fecal microbiota transplantation in orally administered capsules or Placebo capsules and dosed twice weekly for 12 weeks. .


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. For sexually active male and female subjects of childbearing potential, agree to use an effective method of birth control during the study.
3. For female subjects of childbearing potential, a negative urine Qualitative HCG pregnancy test at enrollment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
4. Willing and able to sign an informed consent form and attend study assessments and follow up visits.
5. A documented diagnosis of NAFLD without cirrhosis based on imaging or clinical judgment of a gastroenterologist or hepatologist.
6. History of diabetes mellitus
7. Has an attending physician who will provide non-transplant care for the subject.
8. Agrees to maintain a stable regimen including weight loss, exercise, medications to control lipids and glucose, and vitamin E therapy if already prescribed, during participation in the study

Exclusion Criteria:

1. Unable to take multiple capsules orally.
2. Alcohol consumption of greater than an average of one drink per day for women and two drinks per day for men.
3. Hemochromatosis.
4. Hepatic encephalopathy.
5. Compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking oral prednisone \>20 mg a day or prednisone-equivalent)
6. Receipt of systemic non-topical antibiotic therapy within 14 days of treatment day 1.
7. History of use of an investigational drug within 90 days prior to the screening visit.
8. Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
9. Current history for active states of Inflammatory bowel disease, Irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures.
10. History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.
11. Life expectancy of \< 1 year.
12. In the opinion of investigator, subject for any reason, should be excluded from the study.
The Metabolic Effects of Antidepressants in Patients Diagnosed With Major Depressive Disorder

Objective There is growing evidence showing a relation between depression, metabolic syndrome, diabetes, cardiovascular disease (1), serum lipid profile (2,3) and body weight (4), as well as the effects of some of the antidepressant medications on these various conditions and profiles.

The aim of the study is to examine the influence of antidepressant medications on the metabolic profiles (5) of patients suffering from Major Depressive Disorder (MDD).

Group of patients:

30 Patients aged 18-65, who were diagnosed with MDD according to the DSM-IV criteria.

Research Design and Methods:

Research duration will be 8 weeks. Patients meeting the inclusion criteria will be recruited after being diagnosed with MDD and having undertaken the HDRS. A follow-up HDRS will be taken at weeks 4 and 8. The psychiatric evaluation will be held by a resident in psychiatry.

The following metabolic parameters will be examined at base-line and at the end of the 8 weeks:

Weight, height, waist circumference, body mass index (BMI: (Weight in Kg/(Height in meters)2), sitting blood pressure (after 3 minutes of sitting).

Serum lipid profile (performed in Ziv hospital's chemistry lab): Low density lipoprotein cholesterol, High density Lipoprotein cholesterol, Triglycerides, Total cholesterol, Apolipoprotein level (Apo AI, Apo B, Apo E, Apo AII).

Fasting glucose and insulin blood levels, in order to evaluate insulin-release and resistance, according to the following formulas:

Insulin Resistance:

HOMA IR=Fasting glucose (mg/dL)x Fasting insulin (mmol/L)/405

Insulin Release:

HOMA-β={360xfasting insulin (mmol/L)}/{glucose(mg/dL)-63} Serum oxidative stress parameters according to the F2-Isoprostane kit will be measured.

Malonylaialdehyde (MDA) content in serum will be analyzed by the thiobarbituric acid reactive substances assay, which measures malondialdehyde equivalent (13). Conjugated dienes will be measured at 234nm (14, 15).


Eligibility Criteria:
Inclusion Criteria:

* MDD diagnosed patients with a Hamilton Depression Rating Scale (HDRS) score of at least 18 points. Patients not treated with medications or such that had shown resistance to treatment, and were therefore assigned for drug replacement.
* Patients on stable therapy for hypertension, diabetes mellitus, hypothyroidism, dyslipidemia and / or weight lowering medications

Exclusion Criteria:

* Patients receiving antipsychotic treatment as well as patients on mood stabilizers will be excluded.
* Patients with uncontrolled diabetes mellitus, uncontrolled thyroid functioning, or uncontrolled hypertension, as well as patients who regularly consume alcohol will be excluded.
* Patients with uncontrolled malignancy are excluded as well.
Deep Sedation in Catheter Ablation of Atrial Fibrillation

The current practice of anesthesia for atrial fibrillation catheter ablation （CA） procedure is inconsistent, including general anesthesia, deep sedation, and conscious sedation.Due to the nature of deep sedation, it has been continuously gaining its position as one of the crucial components in standard practices of atrial fibrillation ablation during the last decade. Currently, a considerable number of procedures have been done using conscious sedation. Previous studies explored the benefits obtained from the employment of deep sedation in AF ablation procedures, mainly focused on pain reduction and intra-procedural safety. However, the benefits on long-term rhythmic outcomes, peri-procedural safety as well as benefits on procedural parameters and peri-procedural experiences from patients/ablators/lab staff have yet not to be thoroughly studied. We plan to conduct a prospective, multicenter, randomized, controlled trial to evaluate the benefits of deep sedation in catheter ablation of paroxysmal and persistent AF in multiple prospective, i.e., quantified intraprocedural patients / physicians / lab staffs / mapper clinical specialist experiences, and the procedure safety.


Eligibility Criteria:
Inclusion Criteria:

● Patients diagnosed with AF (paroxysmal, persistent, or long-standing) at 18-75 years old who are eligible for the CA procedure

Exclusion Criteria:

* has received CA procedure for AF or atrial septal defect repair before enrollment
* left atrial diameter (LAD) ≥55 mm or thrombosis in the left atrium;
* eGFR\<30mL/min/1.73㎡
* a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack \[TIA\])
* acute or severe systemic infection
* intolerant to sedation or with a history suggestive of sleep apnea
* BMI \> 35 kg/㎡
* has contraindications to procedural sedation or refused to participate in this trial
* Congenital heart disease, thyroid dysfunction, severe hepatic insufficiency (Child-Pugh classification B-C), severe coagulation dysfunction (international normalized ratio (INR) \> 1.5 or partial activated prothrombin time (APTT) prolonged by ≥ 10 seconds, or plasma prothrombin time (PT) prolonged by ≥ 3 seconds, or fibrinogen (Fib) ≤ 1.5 g/L), or active bleeding
* pregnant women, breastfeeding women or women who plan to become pregnant during the study period, those who have a positive pregnancy test result during the screening period
* life expectancy \< 12 months
* those who have participated in other clinical drug trials within 3 months prior to enrollment
* those who are known to be allergic to any of the ingredients such as lidocaine, propofol, soybeans, peanuts, etc.
* those who, in the judgment of the investigator, are not suitable for this clinical study (e.g., not in line with the treatment that the research participants the treatment, research participant compliance, etc.).
Reconstruction of Upper Eyelid With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graf

To study the results of a modified Cutler-Beard technique , using a contralateral tarsoconjunctival graft, in patients who underwent excision of large malignant tumors of the upper eyelid

A tarsoconjunctival graft was harvested from the contralateral upper eyelid, with an extra 3 mm of conjunctiva from the superior edge of tarsus and was attached to the upper eyelid defect, differently than previously described.

Functional, cosmetic outcomes and postoperative complications were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Upper eyelid defect after tumor resection

Exclusion Criteria:

* previous surgery
Understanding New Semantic Memory Learnings Across the Lifespan

The aim of this research is to specify the changes in brain connectivity (i.e. EEG phase synchronisation between brain regions) associated with semantic learning between individuals belonging to different age groups.

Semantic memory is a crucial concept in cognitive science. It has long been conceptualised as a static, amodal memory system containing knowledge about the world, concepts and symbols. Although recourse to this concept is inevitable, the mechanisms, both cognitive and neurobiological, that govern it are far from being elucidated. There are many debates and controversies in this fundamental field of cognitive science, and more specifically around the question of the acquisition and formation of knowledge in semantic memory. The literature on the development of semantic memory during ontogeny is full of contradictions.

A review of this literature highlights the many unanswered questions surrounding semantic memory. How quickly is information encoded and then consolidated into a format that justifies the term semantic knowledge? What are the neural bases underlying the formation of knowledge in semantic memory? How does semantic knowledge evolve through new episodes? How do these mechanisms evolve during ontogeny? To what extent can some semantic learning be preserved from cognitive ageing? In the face of these many questions, the literature highlights the lack of tasks enabling semantic memory to be approached in an operational manner and the need to specify the cerebral mechanisms involved at different ages of life.

The general hypotheses that will be tested as part of the ULIS project are as follows:

1. New semantic learning is possible independently of episodic memory processes.
2. This learning differs according to the age of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Non-opposition by the participant or those exercising parental authority in the case of minors
* French language fluency (assessed by the investigating team)
* Absence of global cognitive deficit attested by a score on the MOCA (Montreal Cognitive Assessment) scale greater than or equal to 26/30 (test carried out at inclusion).

Exclusion Criteria:

* Person subject to a guardianship, curatorship or safeguard of justice measure
* Non affiliation to a social security scheme
Evaluation of Self-ligating Brackets Plus Minor Surgery in Treating Crowded Cases of Malocclusion

Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be admitted then the initial diagnostic records (diagnostic gypsum samples - internal and external oral photographs as well as radiographic images) will be studied to ensure that the selection criteria are accurately matched.

The aim of this study is to compare three groups of patients with severe crowding of the upper anterior teeth:

* Group 1 : Patients will be treated using self-ligating brackets
* Group 2 : Patients will be treated using self-ligating brackets associated with flapless corticotomy.
* Group 3 : Patients will be treated using traditional brackets (i.e. brackets positioned on the labial surface of the teeth)

At the end of leveling and aligning phase, we will compare the self-ligating brackets and traditional brackets ( the acceleration of teeth movement, dental and alveolar changes and other variables ) Also, there is an intention to study the effectiveness of using flapless corticotomy with the self-ligating brackets.

The sample of this study will be chosen according the following steps:

* The examination of patients referred to the Department of Orthodontics at the University of Damascus Dental School (clinical examination, diagnostic plaster models, radiographic photos , external and internal oral photographs) then subjects who meet the inclusion criteria will be included in this trial.
* A random sample of 100 patients from the sampling frame will be chosen.
* An information sheet ( including the research objective and treatment plan in detail ) will be given to each candidate. Then consent forms will be collected from those who agree to participate.
* A random selection of 60 patients will be performed. Then a random distribution of these patients to 3 groups will be done.

Eligibility Criteria:
Inclusion Criteria:

1. Age of patients: 17-28 years.
2. Severe crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires at least two upper extraction.
3. The Little's Index of Irregularity is over 7 mm.
4. There is no previous orthodontic treatment.
5. The patient dose not take any drug may interfere with the tooth movement (Cortisone, NSAIDs, ...).
6. The patient has good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness (1963).
7. Class I or mild class II (ANB ≤ 5) or mild class III (ANB ≥ 0) skeletal relationship.
8. Overbite is between 0-4 mm.
9. There is no skeletal constriction on the upper jaw.
10. Full presence of all permanent teeth in the dental arch (except for third molars)

Exclusion Criteria:

1. Any systemic diseases that would affect tooth movement .
2. Any congenital syndromes or cleft lip and palate cases
3. Bad oral health
Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer

The purpose of this study is to determine the long term tolerability and safety of dalteparin in subjects with cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects, age greater than or equal to 18 years of age.
2. Females should be either of non-childbearing potential as a result of surgery, radiation therapy, menopause (one year post onset), or of childbearing potential and willing to adhere to an acceptable method of pregnancy prevention.
3. Subjects must be newly diagnosed, symptomatic proximal deep-vein thrombosis of the lower extremity, pulmonary embolism, or both.
4. Subjects must have active malignancy defined as a diagnosis of cancer (excluding basal cell or squamous cell carcinoma of the skin) within six months before enrollment, having received any treatment for cancer within the previous six months, or having documented recurrent or metastatic cancer.
5. Prior to enrollment, subjects must not have received therapeutic doses of anticoagulant therapy (including low molecular weight heparin \[LMWH\]) for \>48 hours (or \>4 doses within 48 hours).
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
7. Subjects must have a life expectancy of \>6 months.
8. Subjects must have a platelet count of \>75,000 mm\^3.
9. The subject must not be on any oral anticoagulant therapy for concomitant diseases.
10. Subjects must have no active or serious bleeding episodes within two weeks prior to study entry.
11. Subjects must be able to comply with scheduled follow-ups.

Exclusion Criteria:

1. Subjects who have a high risk of serious bleeding (e.g., recent neurosurgery within 30 days, history of intracranial hemorrhage, acute gastroduodenal ulcer, etc.).
2. Subjects who are on hemodialysis.
3. Subjects who have a prior placement of a Greenfield filter or other device to prevent embolization of deep vein thromboses.
4. Subjects with a known contraindication to the use of heparin (e.g., heparin-induced thrombocytopenia).
5. Subjects with a known hypersensitivity to heparin, dalteparin sodium, other LMWHs or pork products.
6. Subjects who are currently participating in another clinical trial involving anticoagulation therapy (with the exception of acetylsalicylic acid (ASA) in the 30 days prior to study entry, or who are actively using any investigational drugs/treatments 30 days prior to study entry involving anticoagulation therapy (with the exception of ASA , t.i.d).
7. Subject is pregnant or breast feeding.
8. Subjects with uncontrolled hypertension characterized by a sustained systolic pressure \>170 mmHg and/or diastolic pressure \>100 mmHg.
9. Subjects with a serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the subject's ability to complete the study.
10. Any condition that makes the subject unsuitable in the opinion of the investigator.
11. Subjects with leukemia or myeloproliferative syndrome.