cyrilzakka/clinical-trials huggingface dataset:
Endometrial Curettage Before Embryo Transfer

Studies have shown that endometrial sampling in the month prior to embryo transfer may increase pregnancy rates. We wish to test this hypothesis by performing a hysteroscopy and curettage in the month proceeding embryo transfer during IVF, IVF/ICSI or Frozen/Thawed cycles.

It has been suggested that local injury to the endometrium doubles the rate of implantation and successful pregnancies in IVF patients.

Purpose

1. To determine whether performing curettage the month prior to embryo transfer (ET) increases the chance of embryo implantation.
2. To study molecular attributes of the endometrium taken at curettage and to compare them to those cycles resulting in pregnancy and those which do not result in pregnancy.

Samples will be grown as primary culture in the research laboratory and possible molecular markers and attachment assays for endometrial receptivity will be studied.

Patient selection: Patients undergoing IVF or IVF-ICSI at Ha'Emek medical center/ IVF unit. Woman over 35 years of age will be excluded since implantation failure is more likely to be due to genetic, chromosomal or cytoplasmic aberrations in their oocytes.

Proposed protocol:

1. Informed consent obtained from prospective candidates.
2. Participants randomly divided to three groups

   1. Control group
   2. Hysteroscopy and curettage performed on days 15-17 of menstrual cycle
   3. Hysteroscopy and curettage performed on days 19-22 of menstrual cycle
3. After the following menses an IVF, IVF-ICSI, or frozen embryo cycle is performed according to the unit's standard protocols.
4. The primary end point of the study will be the implantation rate after ET and the expression of possible molecular markers for endometrial receptivity in the pregnant patients.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* In-vitro fertilization candidate
* Normal blood coagulation

Exclusion Criteria:

* Anemia (hemoglobin under 10 mg/dl)
* Abnormal maternal karyotype
* Thrombocytopenia under 140,000
* Any contraindication to hysteroscopy or in-vitro fertilization
Assessment of Cost-effectiveness in Two Empirically-based Psychotherapies for Borderline Personality Disorder: A Randomized Controlled Trial

Patients suffering from borderline personality disorder (BPD) are considered frequent utilizers of psychiatric emergency rooms and of psychiatric hospitalizations. Nonetheless, recent studies challenge the effectiveness of psychiatric hospitalizations in reducing BPD symptoms, and some have even indicated potentially harmful effects such as increasing suicide risk post-discharge. These findings highlight the importance of effective outpatient treatments for BPD patients in public psychiatric hospital settings. In this study we aim to assess the effectiveness and cost-effectiveness of two empirically-based treatments for BPD: dialectical behavior therapy (DBT) and dynamic deconstructive psychotherapy (DDP).

In this study we aim to assess the effectiveness and cost-effectiveness of two empirically-based treatments for BPD: dialectical behavior therapy (DBT) and dynamic deconstructive psychotherapy (DDP). Sixty-eight participants with BPD will be randomized to each of two treatment groups. Participants and therapists will be recruited from the Shalvata MHC, a 139-bed psychiatric institution with outpatient units serving a population of more than 600,000 people in Israel. A blinded research assistant will administer primary and secondary outcome measures every 3 months during the 12 months of treatment and at the end of the 6-month naturalistic follow-up period after ending treatment with DDP or DBT. Therapist adherence will be systematically assessed in both treatments for 10% of sessions. Primary outcome measure will be comprised of the Incremental cost-effectiveness ratio (ICER), as assessed by estimating the healthcare utilization costs per incremental improvement in suicide severity. Secondary outcome measures will include BPD and depression symptom severity and quality of life. This study was submitted to the institutional review board of the Shalvata MHC in November 2019, and is expected to be approved by late Janury 2020.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 45 years old
* diagnosis of BPD,
* history of a suicide attempt within the prior year with presence of current suicidal ideation,
* agrees to participate in psychotherapy
* signed informed consent,

Exclusion Criteria:

* meet diagnostic criteria for schizophrenia, schizoaffective disorders, or have severe intellectual impairment.
18F-FDG PET/MR Imaging for Differentiation of Serous From Non-Serous Pancreatic Cystic Neoplasms: A Pilot Study

The overlap of morphological imaging features results in many incidentally detected pancreatic cystic neoplasms going undiagnosed, including benign serous cystic neoplasms (SCN) and potentially malignant mucinous lesions (nonserous). The diagnostic ambiguity then lead to invasive procedures such as endoscopic ultrasonography (EUS), unwarranted surgical resection on SCN lesions or the need for long term periodic surveillance with delayed diagnosis of potentially malignant nonserous lesions. Therefore, precise differentiation of SCN from nonserous cystic neoplasms is highly desirable.

The 18F-fluorodeoxyglucose (FDG) accumulation in tumor cells, which is induced by high expression of glucose transporter proteins (mainly include GLUT-1 and -3), can be used to discriminate malignant and benign pancreatic cystic tumors in positron emission tomography (PET) imaging. GLUT-1 expression has also been documented in benign SCN while no such evidence exists in potentially malignant nonserous cystic neoplasms. Based on this evidence, investigators will conduct a pilot study to evaluate if integrated 18F-FDG PET/MR imaging with simultaneous MR and PET acquisition is helpful in differentiation of SCN from nonserous lesions.


Eligibility Criteria:
Inclusion Criteria:

-Patients with known pancreatic cystic lesions, including suspected pancreatic serous cystic neoplasms and non-serous cystic neoplasms

Exclusion criteria:

* General Contraindications to MRI such as pacemaker, brain aneurysm clip etc. -
* Pregnancy
* Age below 18 years
* Estimated GFR (eGFR \< 30 mL/min)
* MRI contrast allergy;
Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the last decade, and in many places the demand largely surpasses the capacities of the treatment centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There are currently no drugs that are easily administered and have low toxicity, and might thus be used as tools to support disease control.

This study aims to compare the safety and efficacy of DB289, a new, orally administered dication prodrug to pentamidine i.m. injection for the treatment of first stage sleeping sickness. The project will be executed in the framework of an international consortium consisting of several partners from academia, industry and from the Democratic Republic of Congo Ministries of Health.


Eligibility Criteria:
Inclusion Criteria:

1. The patient has early stage T. b. gambiense infection i.e. parasitologically confirmed infection in the blood or lymph node aspirate and greater than or equal to 5 WBC mm-3 detected in the CSF by microscopic examination
2. Patient is 15 to 50 years old
3. Patient has a minimal weight of 35 kilograms
4. If the patient is female of child bearing potential (a women will be considered of non-child bearing potential only if she has been post menopausal for over 2 years or has had a hysterectomy):

   1. she is not lactating,
   2. she had a negative urine pregnancy test result within 24 hours prior to DB289 treatment and
   3. she agrees to use a medically proven method of contraception (abstinence from sexual intercourse is an acceptable method) from the day of consent on until the end of the observation period (day 7).
5. Patient has understood and signed the Informed Consent. If the patient is minor, a legal guardian has signed the Informed Consent

Exclusion Criteria:

1. The patient has late stage T.b. gambiense infection i.e. presence of parasite in the CSF upon microscopic examination or a WBC count of \> 5mm-1
2. Active clinically relevant medical conditions that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to: significant liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, infection including known HIV infection, CNS trauma or seizure disorders (A list of typical signs and symptoms is provided for guidance of the investigator in attachment 1)
3. Coma Score of less than 9 on the Glasgow Coma Scale (Appendix 8)
4. Withdrawal of consent at any time during the study
5. Any condition which compromises ability to communicate with the investigator as required for the completion of this study.
6. The subject has been previously treated for African Trypanosomiasis.
7. The subject has been previously enrolled in the study. -
Effect of Chewing a Calcium Supplement Before Fluoride Rinse on Salivary Fluoride

The anticaries effect of fluoride is through the increase in fluoride presence and retention in the oral fluids, reducing dental demineralization and enhancing remineralization. Previous studies showed that a preapplication of calcium (in a rinse) prior to administration of fluoride greatly enhances fluoride concentration in the mouth and the anticaries effect of fluoride. The hypothesis of this study is that the same can be achieved by chewing a calcium supplement prior to a fluoride rinse. The first goal is to determine if chewing these calcium supplements will increase calcium concentration in the oral fluids above baseline levels. Secondly, the calcium supplement with the highest calcium release will be tested before a fluoride rinse to assess the increased retention of fluoride in the oral fluids when compared with the fluoride rinse alone. In both parts, healthy volunteers will participate and saliva will be collected to assess calcium and fluoride concentration.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Reported good general health
* Reported good oral health
* Having at least 20 teeth in the mouth, being at least 4 (natural or crowned) teeth in all four quadrants of the mouth
* Having normal salivary flow rate according to direct flow rate determination methods
* Agreement to adhere to the study protocol

Exclusion Criteria:

* Unable to understand and/or follow study instructions
* Hyposalivation
* Active periodontitis, identified by frequent bleeding of the gums
* Oral pain
* In need of urgent dental care
Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.

Evaluation of the efficacy, tolerance, quality of life and cost effectiveness of the association of Oxaliplatin, Gemcitabine, Rituximab and Dexamethasone for treatment of patients with refractory or relapsing non-Hodgkin lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years or above at the time of inclusion.
2. Documented CD20+ NHL, refractory or relapsing after first line chemotherapy.
3. No contraindication to Oxaliplatin, Gemcitabine, Dexamethasone or Rituximab.

Exclusion Criteria:

1. Other types of non-Hodgkin lymphoma
2. Pregnancy and lactation.
3. Patient unable to give written informed consent.
4. Contra-indication ou intolerance to any of the components of the RGDOx chemotherapy.
Novel Quantification Methods for Fluorescence to Detect Progression in Stargardt Disease

The purpose of this study is to utilize flavoprotein fluorescence and fundus autofluorescence to detect progression of Stargardt macular dystrophy in a pediatric population over the course of a year with the hope of aiding future therapeutic risk-benefit decisions and assessment of outcomes.

Stargardt macular dystrophy is the most common of the juvenile-onset macular dystrophies. Despite determination of ABCA4 as the causative gene, clinicians have been challenged by variability in clinical phenotypes. Given the recent initiation of clinical trials to assess novel treatments (e.g. gene therapy), there is a need to identify patients with the worst prognosis.

The investigators have observed that pediatric patients lose central visual function faster than their adult counterparts. Thus, they present an ideal cohort with which to determine the utility of novel modalities to detect early change. These include flavoprotein fluorescence, a new imaging technique for detecting mitochondrial dysfunction developed at the University of Michigan. Fundus autofluorescence (FAF) is another commonly utilized technique of evaluating hereditary eye diseases. The investigators have developed a novel means of quantifying FAF signatures that will allow documentation of severity as well as detection of progression.

This study will evaluate whether more sophisticated testing and analytic methodologies, including fundus autofluorescence (FAF) and a novel non-invasive method to measure retinal flavoprotein fluorescence (FPF) may be used to better predict Stargardt macular dystrophy progression and monitor treatment effects than conventional modalities such visual acuity and visual field. This method involves the use of novel statistical methods to assess the heterogeneity of fundus autofluorescence images.

Participants will complete 3 visits to the University of Michigan Kellogg Eye Center. Each visit will take approximately 2.5 hours. The initial visit will include a routine clinical eye examination, measurement of best-corrected visual acuity, indirect ophthalmoscopy, microperimetry, frequency-domain optical coherence tomography, Goldmann visual fields, fundus flavoprotein fluorescence (FPF) imaging, and fundus autofluorescence (FAF) and fundus photography. Patients will return for evaluation at 6 and 12 months after their initial visit to repeat testing and imaging.

Eligibility Criteria:
Inclusion Criteria:

* Between the age of 5 and 18 years old
* Clinical diagnosis of Stargardt Disease
* Molecular confirmation of Stargardt Disease (with 2 identified mutations in ABCA4)
* Visual acuity better than 20/100

Exclusion Criteria:

* Limited central vision, defined as visual acuity worse than 20/100
* A diagnosis of any other retinal degenerative disease
A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS

A phase 2 double-blind, placebo-controlled study of AL001 in participants with C9orf72-associated ALS.

This is a phase 2 double-blind, placebo-controlled trial to test the safety, tolerability, pharmacokinetics, and pharmacodynamics of AL001 in participants with C9orf72-associated Amyotrophic Lateral Sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Confirmation of C9orf72 mutation
* Diagnosis of ALS by revised El Escorial criteria
* Time since onset of muscle weakness due to ALS ≤36 months at the time of the Screening Visit
* Slow Vital Capacity (VC) ≥50% of predicted capacity at the time of the Screening Visit
* If taking riluzole, must be on a stable dose of riluzole for at least 30 days prior to the Screening Visit. Riluzole naive participants are allowed.
* If taking edaravone, must have completed at least one cycle of edaravone prior to the Screening Visit and plan to continue edaravone during the study. Edaravone naive participants are allowed.
* Females must not be pregnant, breastfeeding or planning to conceive within the study period. Males must agree to use acceptable contraception
* Capable of providing informed consent at the Screening visit and complying with study procedures throughout the study

Exclusion Criteria:

* Clinically significant, unstable, medical condition (other than ALS)
* Clinically significant heart disease, liver disease or kidney disease
* Cognitive impairment or dementia
* Current uncontrolled hypertension
* History of unresolved cancer
* Any experimental gene therapy
* Any experimental vaccine (any vaccine against COVID-19 either approved or administered under an Emergency Use Authorization is allowed)
Quantification of Kinematics and Muscle Activity Patterns of the Upper Extremities of Individuals With Motor Disabilities

The subjet is sitting on a chair and in front of him an adjustable (height) table with a glass of water. 17 passive reflective markers are placed on his upper extremities and torso. The subject is requested to reach the glass (once with the right hand and then with the left hand) and bring it to the mouth and drink. Then the subject put the glass back at the starting position. This is performed twice for each hand. In the second part, the same trial is repeated but muscle activity is recorded with surface electromyography.


Eligibility Criteria:
Inclusion Criteria:

* motor impairment following stroke, multiple sclerosis, cerebral palsy, traumatic brain injury, spina bifida, poliomyelitis, neuropathy
* Able to understand and sign an informed consent form independently.

Exclusion Criteria:

* Unable to hold or lift a glass
* pregnant women
Effects of MAC Preventive Therapy on Disease-Causing Bacteria in HIV-Infected Patients: A Substudy of CPCRA 048

Some people who have taken azithromycin to prevent MAC (Mycobacterium avium Complex, a bacterial infection common in HIV-infected persons) have been found to carry antibiotic-resistant bacteria (germs that grow despite the presence of drugs used to kill them). The purpose of this study is to see if people who take azithromycin carry more antibiotic-resistant bacteria than people who have chosen to delay MAC preventive therapy.

When bacteria like Streptococcus (a type of bacteria that causes pneumonia and meningitis) are frequently exposed to antibiotics, the bacteria can become resistant to the drugs. MAC preventive therapy uses antibiotics, but this can make it difficult to treat other infections caused by bacteria that have become resistant in HIV-infected persons. If MAC preventive therapy is delayed, Streptococcus in the body may be less likely to develop resistance. Therefore, if the patient does get a Streptococcus infection, it will be easier to treat because it is not resistant to the antibiotics.

Streptococcus pneumoniae is a leading cause of bacteremia, pneumonia, meningitis, and otitis media in the United States. Prior to 1987, this organism was uniformly susceptible to penicillin; since then, however, increasing numbers of isolates resistant to penicillin, as well as to other common antibiotics, have been identified. Frequent exposure to antibiotics has been documented as an important risk factor for the emergence of resistant organisms in HIV-infected patients, who are more likely than uninfected people to be colonized with antibiotic-resistant strains of S. pneumoniae. This substudy is the first to examine the effects of withdrawing or delaying the initiation of prophylaxis (in this case, MAC prophylaxis) on the prevalence of antibiotic-resistant pneumococci in a prospective manner.

Study participants are a subset of those enrolled in the CR-MAC Protocol (CPCRA 048). Oropharyngeal swabs are taken at baseline and 4 months after randomization, and are used to isolate S. pneumoniae in culture. These isolates are tested for susceptibility to macrolides, penicillin, cephalosporins, quinolones, and TMP-SMX. The rates of pneumococcal colonization at baseline and 4 months after randomization are determined and used to estimate the impact of deferring MAC prophylaxis on carriage of antibiotic-resistant S. pneumoniae.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are enrolled in CPCRA 048.
Different Doses of Vitamin A and Childhood Morbidity and Mortality

Vitamin A supplementation reduces all-cause mortality. It is therefore given with oral polio vaccine in national campaigns. However, it is not clear which dose is optimal. The two studies that have investigated the impact of different doses of vitamin A have both found that a smaller dose was better than a large dose. We therefore investigated if a smaller dose given with oral polio vaccine gives equal or better effect.

Vitamin A supplementation (VAS) to children above 6 months of age reduces all-cause mortality with 23 %1 to 30 % in low-income countries. WHO recommends VAS at vaccination contacts. The currently recommended doses to be administered every 3-6 months are 100,000 IU for infants between 6 and 11 months of age and 200,000 IU for children 12 months and older. There is no clear evidence that a large dose is better than a small dose, the tendency being the opposite in the two studies of different doses of VAS that have been published so far.

With the global effort to eradicate polio, national immunization days with oral polio vaccine (OPV) offer an additional opportunity to provide vitamin A. In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we aimed to examine whether the dose of vitamin A currently recommended by WHO or half this dose gives a better protection against childhood morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:Between 6 mo and 5 years old and thus eligible for OPV and vitamin A during national immunisation day

-

Exclusion Criteria:Children with overt signs of vitamin A deficiency will not be enrolled in the study, but treated according to the recommendations. -
Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty

The aim of this study is to demostrate the eficcacy in pain control management after total knee arthroplasty of Gonyautoxin. Local administration during surgery of Gonyautoxin before wound closure can achieved better pain control and lower morphin use during hospital stay compared to local administration of chirocaine, ketorolac and epinephrine


Eligibility Criteria:
Inclusion Criteria:

* Patients who required total knee arthroplasty due to knee osteoarthritis ( Kellgren and Lawrence score of 2 or more), with no response to conservative management.
* Without known allergies to the drugs used in the study
* Anesthetic risk: ASA Score 1,2,3.

Exclusion Criteria:

* Obesity, defined as body Mass index over 35
* Previous Knee surgery
* Mellitus diabetes
* Organic brain damage
* Rheumatic Arthritis
* Coagulation deficit
* Liver disease
* Chronic obstructive pulmonary disease
* Chronic consumption of opiods
* Refusal to participate in the study
A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer

The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.

All women will be given two types of Jell. One should be applied immediately after radiation and the second one, 3 times every day. All women will complete detailed questionnaire every two weeks and will be evaluated by the treating team at the same time.All women will be evaluated two weeks after end of radiation period.

Eligibility Criteria:
Inclusion Criteria:

1. Woman with histologically confirmed breast cancer who underwent lumpectomy and requires adjuvant radiation therapy with 2 Gy/fx to a total dose of 50 Gy.
2. Women who received neoadjuvant or adjuvant chemotherapy are eligible for the study. Three weeks is the minimal interval between chemotherapy and start of radiation therapy.
3. Patient able to understand the study designed and cooperate with instructions of use.
4. Patient able to sign informed consent

Exclusion Criteria:

1. Woman with lactose allergy (lactose intolerance are eligible)
2. Woman with known connective tissue disorder
3. Woman with uncontrolled diabetes
4. Patients receiving radiation protocol with 2.64 Gy/fx or 1.8 Gy/fx
5. Woman who is unable to sign an informed consent