cyrilzakka/clinical-trials huggingface dataset:
Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

This phase I study will involve escalating doses of CAMPATH until the goal dose for the cohort is tolerated. The CAMPATH goal dose will be administered to the patient subcutaneously (SQ) 3 times per week for up to 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed or refractory hematologic malignancy. The anticipated patient population are patients with chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma or myeloma
* Patients with a history of a hematologic malignancy that has previously been shown by flow cytometry or immunophenotyping analysis to express CD52
* Any chemotherapy, major surgery or irradiation must have been completed at least four (4) weeks before enrollment in this study (6 weeks for mitomycin-C or nitrosourea)
* Patients have recovered from the acute side effects due to prior therapy
* Life expectancy of \> 3 months
* World Health Organization (WHO) Performance Status 0-2
* 18 years of age or older
* Adequate organ function as defined in the protocol

Exclusion Criteria:

* Prior therapy with CAMPATH
* Use of an investigational agent within two (2) weeks prior to study enrollment
* History of anaphylaxis following exposure to humanized monoclonal antibodies
* Known human immunodeficiency virus (HIV) positive
* Prior autologous bone marrow or stem cell transplant if within six (6) months of study entry
* A history or prior allogenic bone marrow transplant or organ transplant
* Known, symptomatic central nervous system (CNS) involvement with lymphoma
* Pregnant or lactating women
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (excluding skin infection, lower urinary tract infection, or oral infection), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Comparison of Effects of Interactive Video Games in the Elderly

The aim of this study is to assess the effectiveness of interactive video-games on mobility and wellbeing and to compare them with activity-based approaches in geriatric population.

100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the criteria will be included in the study. Persons will be placed in the study groups in consideration of their interests. One group will be included in Nintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation, and video-games will run for 30 minutes two days a week for 8 weeks. The other group will participate a program consisting of various physical activities for the same duration; The results of both groups will be compared with a control group.

100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the criteria will be included in the study. Persons will be placed in the study groups in consideration of their interests. One group will be included in Nintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation, and video-games will run for 30 minutes two days a week for 8 weeks. The other group will participate a program consisting of various physical activities for the same duration; The results of both groups will be compared with a control group.

Eligibility Criteria:
Inclusion Criteria:

* mini mental test score abowe 21 age between 65 and 85

Exclusion Criteria:

neurological disorders orthopedical problems

-
NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURpura of Adults

Immunologic thrombcytopenic purpura (ITP) affects both children and adults. The incidence is estimated in adults about 1,6/100 000/per year. Chronic and relapsing forms of the disease that represent 70% of adult cases are associated with impairment of quality of life related to treatments side effects and bleeding. ITP is secondary to the destruction of circulating platelets through an auto-immune process and to a decrease of platelet production in bone marrow. Auto antibodies are usually directed against epitopes of the GPIIb/IIIa, expressed by platelets. The destruction of the platelets seems to occur mainly in the spleen through antibody dependent cytotoxicity. Both macrophages and cytotoxic T lymphocytes subsets participate to the platelet destruction through the CD16, the low affinity receptor for the Fc of IgG. Thus the CD16 "pathway" is a target for treatments in ITP as for example intravenous immunoglobulins and more recently inhibitors of the syk kinase.

Natural Killer cells (NK) cells, who are now implicated in the pathophysiology of several autoimmune diseases, express CD16 and display antibody dependent cytotoxicty. Moreover NK cells are present in human spleen. However their role in ITP has not been studied so far. NK could represent a new target for treatments in ITP. We propose thus to conduct a study to characterizes NK cells changes in patients with ITP.

Eligibility Criteria:
Inclusion Criteria:

* ITP patients,platelets less than 50000 G/L

Exclusion Criteria:

* Secondary ITP (VIH, VHC...)
* treatment with Immunosuppressive agents except corticoids (10 mg/day)
* treatment with Ig IV less than 3 weeks
* treatment with Rifuximab less than 6 months
Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Oral Health

The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene procedures in pregnant women.

Patients consenting to participate to the study will undergo periodontal evaluation at the baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly assigned to:

* Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair Peribioma mousse twice a day
* Control group: home oral application of Biorepair Peribioma Toothpaste

Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months.

The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene procedures in pregnant women.

Patients consenting to participate to the study will undergo periodontal evaluation at the baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly assigned to:

* Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair Peribioma mousse twice a day
* Control group: home oral application of Biorepair Peribioma Toothpaste

Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months, the following indexes will be assessed: Probing Pocket Depth, Bleeding on Probing (percentage), Clinical Attachment Loss, Gingival recession, Plaque Control Record, Modified Gingival Index, Papillary Marginal Gingival Index.

Eligibility Criteria:
Inclusion Criteria:

* women at the 4th month of pregnancy

Exclusion Criteria:

* presence of cardiac pacemaker
* neurological and psychiatric diseases
* patients taking bisphosphonates during the previous 12 months from the beginning of the study
* patients undergoing anticancer therapy.
* patients with poor compliance.
Bibloc Mandibular Advancement Oral Device and Its Effect on TMJ Health

The goal of this clinical trial is to learn if Mandibular Advancement Device( MAD) works to treat Obstructive sleep apnea in adults. It will also learn about the effect of the device on the Tempromandibular Joint Health . The main questions it aims to answer are:

Does MAD lower the number of apnoea and hypopnea participants suffer from during sleep? Would it cause any effect on TMJ health? Researchers will compare between a group of TMD patients with OSA to a non_TMD group of patients also with sleep apnea and both groups will receive a Bibloc MADplacebo (a look-alike substance that contains no drug) to see if it affect the TMJ health.

Participants will:

Wear MAD during sleep (at least 6 hours) every day for 6 months Visit the clinic once after the first week for checkups and adjustment of MAD If needed and then after 3 months and 6 months.

Polysomnography, MRI, and tmd screening was done before the appliance insertion and after 6 months of its insertion.


Eligibility Criteria:
Inclusion Criteria:

- Patients having obstructive sleep apnea syndrome (OSAS) as determined by polysomnography with mild to moderate apnea/hypopnea index ranging from 5 to 30 events per hour of sleep. ( As 5-15 events per hour is considered mild condition, 16-30 is considered moderate).(1)

2- Adequate nasal air flow capacity as determined by qualified otolaryngologist.

Exclusion Criteria:

* patients having Central sleep apnea events as determined by the polysomnography.

  2- patients having cardiovascular disease. 3- History of alcohol, narcotic or psychoactive medications. 4- Serious nasal passage obstructions or allergies. 5- Previous history of treatment with any type of obstructive sleep apnea oral appliances.

  6- Obese patients with BMI more than 30. 7- Missing more than five teeth (excluding third molar). 8- Allergy to acrylic resin.
Predicting the Outcome After Treatment of Meniscal Tears

In this study the investigators examined the ability of orthopaedic surgeons to predict the outcome of surgery and non-operative treatment in patients (age 45 to 70) with a non-obstructive meniscal tear.

The additional benefits of Arthroscopic Partial Meniscectomy (APM) in middle aged patients with a non-obstructive meniscal tear are under scrutiny for years. Despite the most recent publications recommending to apply non-operative treatment (exercise therapy, injections, drugs) instead of APM in this patient group, the expected decrease in number of operations is slower then expected. Orthopaedic surgeons therefore seem unconvinced by the evidence to change practice.

For this reason the investigators conducted an international survey amongst orthopaedic surgeons in which the investigators aimed to (1) determine the ability of orthopaedic surgeons to predict the outcomes of APM and physical therapy (PT) in middle aged patients with a non-obstructive meniscal tear, and (2) to determine which patient factors direct surgeons towards APM and towards PT.

Eligibility Criteria:
In this survey the investigators invited orthopaedic surgeons and residents from both the Netherlands and Australia to complete a meniscus survey, including a random sample of patients from the Escape trial. The in-/exclusion criteria are listed below.

Inclusion Criteria:

* Patients between 45 and 70 years of age at presentation.
* A meniscal tear visualized on MRI. The meniscal tear can either be isolated or combined with a partial asymptomatic Anterior Cruciate Ligament (ACL) injury or an asymptomatic degenerative ACL shown on MRI with no abnormal clinical findings (a negative Lachman test and Pivot Shift).
* Mental Competence.
* Willingness to comply with follow up schedule.
* Written informed consent.

Exclusion Criteria:

* Knee locking or trauma leading to acute surgery.
* One of the following associated injuries on the index knee:
* A symptomatic partial ACL rupture or any total ACL rupture determined by clinical examination (positive Lachman test and/or positive Pivot Shift) and shown on MRI;
* A complete Posterior Cruciate Ligament (PCL) injury;
* Cartilage change down to bone; grade 4 of the Kellgren Lawrence Grading Scale for Osteoarthritis visualized on X-ray;
* An injury to the lateral/posterolateral ligament complex with significantly increased laxity.
* A history of knee surgery other than diagnostic arthroscopy on the index knee.
* Tumors on MRI suspected for a malignancy.
* Obese patients with Body Mass Index (BMI) \> 35.
* ASA 4-5 patients which can severely interfere with rehabilitation.
* General disease that effects physical function or systemic medication/abuse of steroids (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout, pseudogout)
* Any other medical condition or treatment interfering with the completion or assessment of the trial, e.g. contraindications to MRI or surgery.
* Drugs or alcohol abuse.
Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer

Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301 is an open-label, dose-escalation phase 1 study of PSMA ADC administered IV in subjects with progressive, castration-resistant, metastatic prostate cancer that has progressed after prior taxane therapy. For all subjects, PSMA ADC will be administered in four repeating cycles.


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of progressive, castration-resistant, metastatic prostate cancer.
2. Prior chemotherapy regimens, one of which contains taxane.
3. Eastern Cooperative Oncology Group status of 0 or 1

Exclusion Criteria:

1. Clinically significant cardiac disease or severe debilitation pulmonary disease
2. Evidence of an active infection requiring ongoing antibiotic therapy
3. Any prior treatment with any other therapy targeting PSMA
4. History of drug and/or alcohol abuse
Talk With Me Baby to Enhance the Early Home Language Environment

The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is:

Will the TWMB program increase the time a caregiver talks to their infant?

Participants will:

1. Come to at least four well-child checkups
2. Receive the TWMB program from the provider during the checkups
3. Record their conversations with their infant before they receive the program and after they receive the program four times.


Eligibility Criteria:
Inclusion Criteria:

For this study, each child-caregiver dyad will consist of:

1. A caregiver who will receive TWMB during routine well-childcare checkups (WCC) visits for their child at participating clinics and
2. The child of the above caregiver for whom the WCC visits are conducted.

A potential caregiver participant must meet all the following inclusion criteria to enroll in the study:

1. Be the age of majority or older, as defined by the state of residency.
2. Able to complete study measures in English.
3. Have the legal authority to consent to participate for themselves and to consent on behalf of their child.

To proceed to the follow-up portion of the study, the caregiver (dyad) must have a LENA baseline assessment score that is ≤ 75th percentile compared to a child's age-referenced normative data.

A potential child participant must meet all the following inclusion criteria to be enrolled in the study:

1. Receive WCC at a participating clinic from a participating provider.
2. Be two to six months (+ 0-30 days) old at enrollment.
3. Was born at full term (\> 37 weeks gestation).
4. Was born in a singleton birth (i.e., was the only child delivered during the birth).

Exclusion Criteria:

A potential caregiver participant must not meet any of the following exclusion criteria to enroll in the study:

1. Has a cognitive impairment or a visual or hearing impairment known to the clinic that limits their ability to make decisions about participating or engaging with the assessments, based on the site primary investigator's (PI's) assessment and local human subjects' research policies.
2. Does not live with child or spend at least two full days (i.e., at least 48 hours) per week with the child.
3. Does not plan for the child to continue receiving services at the participating clinic for at least 12 months.

A potential child participant must not meet any of the following exclusion criteria to enroll in the study:

1. Significant developmental delay or cognitive, visual, or hearing impairment known to the clinic.
2. Previously attended WCC visit prior to enrollment that occurred during the TWMB trial.
Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder

The presented randomized-controled study aim to assess the use of internet-based mindfulness intervention via mobile application for 30 days in patients with Major Depressive Disorder (MDD)

Mindfulness-based interventions (MBI) proved to be effective in relapse prevention in MDD. Next, MBI in form of free mobile applications can be an effective augmentation of the treatment as usual (TAU) and can fill a gap in the ambulatory care. Given this background, the aim of this randomized controlled study is to assess the effectiveness of additional MBI via mobile app on the symptom severity and stress levels, compared to TAU.

Eligibility Criteria:
Inclusion Criteria:

* Depression, current ill

Exclusion Criteria:

* acute alcohol- and drug dependency, schizophrenia or psychotic disorder, severe somatic illnes, not having smartphone or not willing to use mobile application
Optimizing Surgical Decisions in Young Adults With Breast Cancer

The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions.

Participants will complete surveys approximately within 1 week of the surgical consult and approximately 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients/surgeons will also have their surgical consultation audio-recorded.

Primary objectives:

* To test the effectiveness of the CONSYDER decision support tool on reducing decisional conflict prior to breast cancer surgery.
* To evaluate the implementation of and mechanisms of use for CONSYDER.

Secondary Objectives:

* To determine the impact of CONSYDER on decision-making preferences, breast cancer knowledge, treatment goals and preferences, anxiety, decisional regret, and self-efficacy in communication.

Exploratory Objectives:

* To explore whether CONSYDER impacts surgical choice.

OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Approximately 800 women will be recruited at 4 study sites (Weill Cornell Medicine, Yale Cancer Center, Dana-Farber Cancer Institute, Duke Cancer Institute), including network affiliate sites, over an approximate 30-month period. All sites will have a 6-month "run-in" period where patients will not be sent CONSYDER. The 6-month blocks may be extended if recruitment targets are not met. Sites will be randomized to begin delivery of CONSYDER to all newly diagnosed women, age ≤44, with Stage 0-III breast cancer as part of routine clinical care; young women will have access to the website whether or not they consent to research study participation.

Eligibility Criteria:
Inclusion Criteria:

* Female aged 18-44
* New diagnosis of Stage 0, 1, 2, or 3 unilateral breast cancer
* English or Spanish speaking

Exclusion Criteria:

* Diagnosis of de novo Stage 4 breast cancer
* Recurrent early-stage breast cancer
* Bilateral breast cancer
Long-term Extension Study of MCI-196

The Primary Objectives of this study are to assess the long-term efficacy of treatment with colestilan (MCI-196) (including combination therapy) and to assess the long-term safety of treatment with colestilan (MCI-196) (including combination therapy).

This study has been terminated because of insufficient patient recruitment. There were no safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* The subject and/or parent(s)/guardian(s) must be capable of providing informed consent, and assent when applicable, in agreement with regional requirements.
* The subject has completed either of the short-term studies, MCI-196-E14 or MCI-196-E16

or

* The subject has been withdrawn from MCI-196-E14, but is eligible to enter this study according to the following rules, as defined in MCI-196-E14:

  * Hyperphosphataemia: Subjects who experienced hyperphosphataemia, defined as any increase in serum phosphorus \[P\] levels above the age-related upper limit of normal(ULN) on two consecutive occasions, and was withdrawn by the Investigator in order to proceed to this study, where flexible dosing with colestilan (MCI-196) is available. Subjects withdrawn from MCI-196-E14 due to hyperphosphataemia may only enter this study after Week 6 of the short-term study, following two consecutive out-of-range P values (one obtained at Week 3 and one obtained at Week 6). After Week 6, subjects meeting the above criteria may enter this study at any time (the two consecutive out-of-range P values having been obtained any time after Week 6 from a scheduled or unscheduled visit).
  * Hypercalcaemia: Subjects treated with CBPB and experiencing hypercalcaemia may be withdrawn from the short-term study at the discretion of the Investigator in order to proceed to this study at any time, where flexible dosing with colestilan (MCI-196) is available.

Exclusion Criteria:

* The subject has current clinically significant medical co-morbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, make the subject unsuitable for inclusion in the study (e.g., the subject currently has or has had a history of seizure disorders, dysphagia, swallowing disorders, predisposition to or current bowel obstruction, ileus or severe gastrointestinal \[GI\] disorders such as chronic or severe constipation \[as judged by the Investigator\], intestinal stenosis, intestinal diverticulum, sigmoid colitis, GI ulcers, current or a history of GI bleeding, or major GI tract surgery).
* The subject is expected to receive immunosuppressant treatment during the course of the study.
* The subject is considered unstable on his/her current treatment for CKD within one month prior to enrolment (e.g., subjects starting treatment with vitamin D or its analogues, or other agents/procedures that may influence bone mineral metabolism \[i.e., serum P and calcium (Ca) levels\]).
* The subject is considered to be non-compliant with study procedures in the opinion of the Investigator.
Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy

The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during standard local excision.

This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care permanent sections for final margin confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation on permanent sections, thus all patients will receive standard of care confirmation following experimental imaging. Individual excisions from consenting patients will be selected, fluorescently labeled and the distance to inked margins measured with TPFM. Following imaging, specimens will be submitted for paraffin processing as per normal procedure and the resulting slides scanned. The distance to the inked margin will be measured on the permanent sections and compared to TPFM to determine accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing treatment for basal cell carcinoma without Mohs surgery at the performance site
* Able to read and understand consent form

Exclusion Criteria:

* None