cyrilzakka/clinical-trials huggingface dataset:
Colorectal Cancer Screening Intervention Trial

Colorectal cancer is the second deadliest among cancers and disproportionately affects African Americans. The Colorectal Cancer Screening Intervention Trial(CCSIT) project has as its goal to test three interventions designed to increase screening rates among medically underserved African Americans in the Metropolitan Atlanta area. It is designed to increase awareness of modifiable risk factors and promote the benefits of screening as a means of early detection of colorectal cancer. mportance of being screened for colorectal cancer,African Americans continue to be disproportionately affected by this disease. The Colorectal Cancer Screening

Despite increased awareness of the importance of being screened for colorectal cancer, African Americans continue to be disproportionately affected by this disease. The Colorectal Cancer Screening Intervention Trial (CCSIT) is designed to test and expand a public health intervention that combines social marketing and community-coalition building efforts.

The purpose of this study is to 1) evaluate the effects of three different approaches on knowledge, attitudes and beliefs (KABs) about colorectal cancer; 2) to examine the effects of three different approaches to adherence to screening guidelines and 3) to evaluate the independent role of setting on screening practices.

Participants age 50 and over are recruited from churches, clinics and senior sites which allows us to examine the impact of setting on participant recruitment and changes to KAB. Pre and post questionnaires are administered to determine the knowledge attitudes and behaviors (KAB) related to screening and to measure psychosocial parameters (self-esteem, perceived stress and social support). These persons are randomized into one of four groups, the control group and three intervention arms: (1) one-on-one counseling sessions, (2) small group educational sessions and (3) financial incentives interventions where out of pocket cost for screening is reimbursed. The counseling and educational interventions incorporate the Health Belief Model and Social Learning Theory.

Eligibility Criteria:
Inclusion Criteria:

* African American
* Previously not screened for colorectal cancer according to ACS guidelines
* Reside in Fulton,,Gwinett,Cobb,Clayton and DeKalb counties
* 50 years of age or older

Exclusion Criteria:

* Non-African American
* Less than 50 years of age
* Previously screened consistent with ACS guideline
The Experience of Affective Touch in Obesity

The aim of the present research is to verify if the pleasantness of affective touch is comparable between women with obesity and healthy women, while measuring the level of social anhedonia and the lifespan experience of affective touch.


Eligibility Criteria:
Inclusion criteria:

* right-handed;
* diagnosis of obesity (i.e., the level of body mass index (BMI( greater than or equal to 30).

Exclusion Criteria:

* Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders
* Evidence of any skin-related condition possibly affecting sensitivity on the participants' forearm (e.g., eczema, scars).
High Intensity Training for Patients with Anxiety

The aim of the current project is to examine the effects of high intensity exercise (by using 1x4 intervals) to reduce symptoms of anxiety in patients in mental health care. The expected benefits for patients are positive health effects, by improving physical fitness and reducing psychological symptom burden. The patients will have the opportunity to learn to use physical activity as a specific measure to be used in their own lives and be a source of coping. Furthermore, knowledge about physical activity and mental health may be applicable in mental health care as a part of a treatment plan.

The study is a randomised controlled trial ("RCT") design with a 1:1 allocation into two groups. The two groups are high intensity exercise (1x4 minutes performed two times per week with a heart rate above 85% of maximal heart rate) and low intensity exercise (45 minutes performed two times per week with a heart rate of approximately 60% of maximal heart rate). The total amount of training sessions for both groups will be eight. The high intensity exercise group will serve as the intervention group, while the low intensity exercise group will serve as an active control group.

The patients will be randomly allocated (randomised) to these groups. An exercise physiologist (holding a master's degree in exercise physiology) will supervise the training sessions. The training sessions will take place in a dedicated room using a treadmill and a heart rate monitor. The training sessions will be individual.

The primary outcome measure will be degree of anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS) and Beck Naxiety Inventory (BAI) prior to the first (pre) and after the last (post) training session is completed. Secondary outcome measures will be compliance, i.e. to what degree the patient is able to sustain the exercise regimen three months after participating in the project, in addition to the patient's blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild/moderate anxiety disorders, aged 18-60 years. Anxiety disorders in accordance with F 41 in ICD-10, including generalised anxiety disorder, agoraphobia/panic disorder, social phobia, post-traumatic stress disorder, hypochondria, and obsessive-compulsive disorder.
* Comorbidity will occur, so the patient may also have depression. However, the main disorder should be anxiety.

Exclusion Criteria:

* Somatic diseases that may impede training: cardiovascular disease, severe asthma, severe COPD, cancer, poorly regulated diabetes.
* Schizophrenia or bipolar disease
* Suicidality (prior attempts or ongoing risk of suicide)
* Substance addiction
Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy

The aim of the study is to evaluate the prevalence of positive anti BP180 and/or anti BP230 serology in the serum of patients with chronic and diffuse pruritus for at least 1 month under immunotherapy and in the absence of obvious pruritic dermatosis (e.g. scabies, contact eczema...).


Eligibility Criteria:
Inclusion Criteria:

* Patient currently receiving immunotherapy (pembrolizumab, nivolumab, atezolizumab, durvalumab) as monotherapy or in combination OR patient who has received immunotherapy (pembrolizumab, nivolumab, atezolizumab, durvalumab) as monotherapy or in combination within the last 6 months.
* Patients with chronic (\> 1 month) diffuse pruritus, which started after the start of immunotherapy and in the absence of an obvious pruritic dermatosis.
* Woman of childbearing age with effective contraception (see GTFG) (estrogen-progestin or intrauterine device or tubal ligation) for 1 month (negative urine/blood pregnancy test) or Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
* Major patient
* Patient having read and understood the information letter and signed the consent form
* Patient affiliated to a social security scheme

Exclusion Criteria:

Pruritus prior to immunotherapy. Bullous pemphigoid prior to immunotherapy End-stage chronic renal failure (GFR \< 15ml/min or dialysis) Clinical jaundice or total bilirubin \> 34 µmol/L Hepatic cholestasis Diabetes mellitus complicated by diabetic neuropathy. History of polycythemia vera History of Hodgkin's lymphoma iron deficiency anemia Current treatment including DPP-4 inhibitors (vildagliptin, linagliptin) Treatment with systemic corticosteroids or immunosuppressant for more than one month.

Pregnant or parturient or breastfeeding woman or absence of proven contraception

· Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship
Review of Charts From Amish/Mennonite Variant PA Patients

The natural history of patients with PA-AMV has not been systematically studied before and there is no published data in the literature about this condition since 1980. There is no evidence-based approach to care of these patients, particularly the younger patients who may no come to medical attention until significant cardiac problems develop. Through systematic review of existing medical records on essentially all known patient with this condition, investigators plan to develop an evidence-based management plan for preventive care of these patients.

The study is designed to provide a comprehensive description of the clinical and biochemical features of propionic academia, Amish/Mennonite variant (PA-AMV). From these data, the investigators hope to identify biomarkers for assessment of clinical course and efficacy of ongoing management.

The investigators plan to identify essentially all known patients who have the Amish/Mennonite variant of Propionic academia (PA-AMV) through collaboration with clinicians who proved care to this extended community. Signed consents include permission to access life-long medical records to allow investigators to define the natural history of this biochemical variant condition. This will include a description the clinical and biochemical features and natural history of patients with propionic acidemia in the Amish/Mennonite population. In particular, there is interest in the cardiac complications of this variant, so investigators will analyze EKG, echo and cardiac MRI findings in above patients. These data will be used to Identify biomarkers for clinical assessment and ongoing management.

There has been no published data on patients with PA-AMV since 1980. Accumulated clinical experience with PA Amish/Mennonite variant patients suggests that these patients tend to have less severe clinical features compared to classic PA. Severe neonatal metabolic decompensation and ketoacidosis are not present in Amish/Mennonite patients we have followed. Describing the natural history and clinical course is essential in this group of patients to further guide their management. There is currently no evidence-based approach to care of these patients, but rather individual medical centers manage patients symptomatically and differently. A uniform, data-driven approach to patient management is needed.

Eligibility Criteria:
Inclusion Criteria:

* Patients homozygous for the PCCB c.606A\>G mutation

Exclusion Criteria:

* Patients who are not homozygous for the PCCB c.1606A\>G mutation
Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction

A research investigation into the efficacy of digital Polymerase Chain Reaction (dPCR) for monitoring measurable residual disease (MRD) during allogeneic hematopoietic stem cell transplantation, with a focus on predicting relapse in patients diagnosed with leukemia, myelodysplastic syndromes (MDS), and related hematological conditions.

This prospective clinical study focuses on patients diagnosed with leukemia, myelodysplastic syndromes (MDS), and related hematological conditions post-allogeneic hematopoietic stem cell transplantation. The primary objective is to assess the efficacy of digital Polymerase Chain Reaction (dPCR) in monitoring measurable residual disease (MRD), including markers such as BCR::ABL, KMT2A, etc., as compared to other MRD monitoring methods such as conventional quantitative PCR or multicolor Flow Cytometry (MFC). Key endpoints include the recurrence of MRD using conventional methods, hematological relapse, disease-free survival, overall survival, and non-relapse mortality.

Eligibility Criteria:
Inclusion Criteria:

* The presence of at least one fusion gene or hematological tumor-associated mutation detected at diagnosis by NGS or real-time PCR provided for posttransplant MRD monitoring.
* Neutrophil engraftment
* Received at least one MRD monitoring by digital PCR after HSCT

Exclusion Criteria:

* Patients who relapsed or died before the first digital PCR monitoring
* Patients only with mutations in DNMT3A, TET2, and ASXL1 ("DTA mutations") or only germline mutations
Influence of Different Doses of the Vitamin B12 on Recurrent Aphthous Stomatitis

Background: The frequency of recurrent aphthous stomatitis (RAS), the most common oral mucosa lesions seen in primary care, is up to 25% in the general population. Sublingual vitamin B12 treatment, 1000 mcg per day for 6 months was found to be effective for patients suffering from RAS, regardless of the serum vitamin B12 level. However, the optimal therapeutic dose of vitamin B12 treatment remains unclear.

Working hypothesis and aims:

Aim-To assesses the influence of different vitamin B12 treatment doses on the frequency and severity of RAS episodes.

Working hypothesis- The group receiving the higher dose of vitamin B12 treatment will have the lower frequency and severity of RAS episodes; the reaction will be faster.

Methods: randomized, double blind, intervention study.

Study population: 75 patients in three groups (total of 225 patients):

Group I- will receive sublingual vitamin B12 treatment, 1000 mcg per day for 6 months Group II- will receive sublingual vitamin B12 treatment, 100 mcg per day for 6 months Group I- will receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months Study design: Study participates will be followed through three study periods: The first period- three months prior to receiving active treatment, the second period- six month of active treatment (with randomization to study groups), and the third period- three month after finishing active treatment. Frequency and severity of RAS episodes will be recorded by the patient with "aphthous diary" that will be filled daily during all study period (12 months).

Expected results: This study will allow us to identify optimal dose of vitamin B12 treatment that will achieve faster and longer remission of RAS episodes.

Importance: This is a very common problem in the population. Study results will help to identify optimal doses of vitamin B12 needed to treat RAS.

Probable implications to Medicine: study results are supposed to give faster and better treatment for RAS episodes


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and older
* Suffer from RAS For at least one year, with aphthous frequency at least once a month.

Exclusion Criteria:

* known sensitivity to vitamin B12
* Don't speak Hebrew, Russian or English.
* Systemic Diseases, known in developing mouth aphthous (Behcet disease, Lupus Erythematosus, rheumatoid arthritis and AIDS disease)
* Patients who have received last year any form of vitamin B12 .
* Patients who receive a different treatment to RAS(not for pain)
* Pregnant or breastfeeding women
* patient suffering from Leber's optic atrophy
* Patients who suffer from Psychosis
Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis

This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).


Eligibility Criteria:
Eligibility criteria include, but are not limited to the following:

* Are between the ages of 18 and 80 years.
* Have been diagnosed with rheumatoid arthritis for at least 6 months.
* Have failed treatment (lack of efficacy) with at least 1 but no more than 5 disease-modifying anti-rheumatic drugs or biologics (other than methotrexate).
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Adult Male Participants

The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of E6130 in Japanese healthy adult male participants.


Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the following criteria to be included in this study.

1. Japanese or Caucasian healthy adult males aged ≥20 and \<45 years at the time of informed consent who are non-smokers or able to stop smoking from at least 4 weeks before study drug administration until the post-treatment examination
2. Has voluntarily consented, in writing, to participate in this study
3. Has been thoroughly briefed on the conditions for participation in the study, and are willing and able to comply with the conditions

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study.

1. History of surgical treatment may affect the pharmacokinetics of the study drug at screening
2. Suspected to have clinically abnormal symptoms or impairment of organ function requiring treatment on the basis of history and complications at screening, and physical findings, vital signs, electrocardiogram findings, or laboratory values at screening or baseline
3. History of drug allergy at screening
4. Judged by the investigator or sub investigator to be inappropriate for participation in this study
Autologous Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian Failure

Premature ovarian failure (POF), also known as premature ovarian insufficiency, primary ovarian insufficiency (this is the most accurate term as some women may still conceive), premature menopause, hypergonadotropic hypogonadism is defined as failure of the ovary to function adequately in a woman younger than 40 years, in its role either as an endocrine organ or as a reproductive organ, a condition characterized by amenorrhea, hypoestrogenism, and elevated serum gonadotropin levels (which demonstrate that the ovaries are no longer responding to circulating FSH by producing estrogen and developing fertile eggs) in women younger than 40 years. This condition occurs in approximately 1% of women and it has important physical and psychological consequences/impact in those patients.

The purpose of this study is to investigate the role of the transplantation of bone marrow derived stem cells into ovarian tissue for treatment of premature ovarian failure and to assess their ability to differentiate into germ cells.

This study is an open-label investigation of the efficacy of injection of autologous adult bone marrow derived stem cells into the ovarian stroma of patients with premature ovarian failure. Sixty women with premature ovarian failure will be recruited in this study after a written informed consent. Diagnosis will be based mainly on history taking, physical examination and investigations. Laboratory investigations will include Serum follicle-stimulating hormone (FSH), serum estrogen measurement and serum AMH. The anterior pituitary secretes FSH and LH at high levels due to the dysfunction of the ovaries and consequent low estrogen levels. Typical FSH in POF patients is over 40 mlU/ml (post-menopausal range). Subjects will be enrolled based on specific inclusion/exclusion criteria and evaluated at regular post transplant intervals. Human adult bone marrow derived stem cells will be transplanted by a gynecological surgeon through a standard surgical approach (transvaginal U/S guided approach). Subjects will be monitored frequently for a total of one year after adult bone marrow stem cells cell injection. For safety of participants, Bone Marrow Stem cells will be injected in one ovary only and the other ovary will be spared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with normal karyotype spontaneous premature ovarian failure.
* Patients between 18 - 40 years old.

Exclusion Criteria:

* Patients with secondary ovarian failure (e.g. hypothalamic causes).
* Pregnancy and lactation.
* Autoimmune diseases.
* Those with major medical problems such as malignancy, hepatitis, etc.
* Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome....).
Trial of Blood Flow Restriction Plus Physical Therapy vs. Physical Therapy Alone for Lateral Epicondylitis

Open label randomized controlled trial comparing evidenced based physical/occupational therapy vs. physical/occupational therapy including blood flow restriction tourniquet in the treatment of lateral epicondylitis (tennis elbow).

Patients will be randomized to one of two groups, and treatment will be open label and unblinded. A target of 44 patients for enrollment has been set for 80% power. Treatment will last for 6 visits with physical therapy with recommended visit intervals of 1 week :

Intervention Group: Evidence based physical/occupational therapy, with the addition of therapeutic exercises using a blood flow restriction tourniquet.

Control Group: Patients will receive standard evidence based physical therapy

The primary outcome (Patient-Rated Tennis Elbow Evaluation \[PRTEE\]) will be collected at enrollment, 3, 6, and 12 months.

Secondary outcomes will be collected at the beginning and end of physical therapy interventions (change in: numeric pain rating scale, maximum pain free grip strength, pain free grip strength). We will collect treatments received after the end of physical therapy and before final follow up.

Eligibility Criteria:
Inclusion Criteria:

* The diagnoses included are lateral elbow pain, lateral epicondylitis, or lateral epicondylalgia, more general diagnoses elbow tendinitis or elbow pain will be included if their clinical picture at physical therapy meets criteria for lateral epicondylitis.
* If the inclusion diagnosis is other than lateral epicondylitis or tennis elbow (such as elbow pain), we will confirm the diagnosis at the first therapy visit with tenderness at the lateral epicondyle and/or pain with resisted wrist/long finger extension at the lateral epicondyle.
* Pain for 4 weeks or more.
* All participants must be between the age of 18 and 70 years old and have had pain for 4 weeks or more.

Exclusion Criteria:

* Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the affected limb will be excluded from the study.
* Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow,
* Vascular disorders to include: history of DVT, history of endothelial dysfunction, peripheral vascular disease
* Injection therapy (corticosteroid, platelet rich plasma, or other injection therapy) in the prior 3 months to the affected site
* Current fracture in affected arm
* History of crush injury to affected arm
* Any surgery on affected arm in last 1 year
* Surgical procedure on their contralateral extremity (Changed 9/2019 to surgery within last year on contralateral upper extremity).
* History of lymphectomy (such as axillary exploration with breast surgery, lymph node biopsy in the affected axilla/arm)
* Pregnancy
* Active infection
* Current cancer diagnosis/treatment
* Sickle cell anemia or trait
* Kidney dialysis
* History of syncope/passing out with pressure to body (such as massage, or blood pressure cuff).
* inability to consent