cyrilzakka/clinical-trials huggingface dataset:
Frequency and Clinical Phenotype of BAP1 Hereditary Predisposition Syndrome

This research will have a significant impact on the overall management of those cancer patients and their family members who are at risk for hereditary cancer due to germline inactivation of BAP1. Our study will ultimately facilitate the development of novel screening, prevention and treatment strategies for these individuals with the syndrome. Because the vast majority of UM develop in pre-existing nevi, characterization of individuals at high risk for development of UM will allow closer screening and earlier intervention which would improve the treatment outcome not only for retaining vision but also for overall survival. Similarly in patients with germline BAP1 mutation CM develops in premalignant atypical melanocytic lesions and careful follow up of these patients will improve the outcome of their disease. In addition this study could have impact on the management of patients with personal and/or family history of several other cancers reported in patients with germline BAP1 mutation such as mesothelioma, renal cell carcinoma, cholangiocarcinoma, hepatocellular carcinoma, meningioma and basal cell carcinoma.

BAP1 (BRCA1-associated protein-1), is a deubiquitinating enzyme with a ubiquitin carboxy-terminal hydrolase function that has been suggested to be a tumor suppressor gene with a role in cell proliferation and growth inhibition. Recently germline mutations in BAP1 have been identified by our group and others in families with hereditary cancers. However, the clinical spectrum of cancers in patients with germline BAP1 is still not clear. The association of germline BAP1 mutations with increased risks for uveal melanoma (UM), mesothelioma, cutaneous melanoma (CM), renal cell carcinoma (RCC) and BAP1-inactivated melanocytic tumors is fairly well established. However, several other cancers have been reported in these patients and their family members including cholangiocarcinoma, hepatocellular carcinoma, meningioma, basal cell carcinoma and other internal malignancies. Identification of the clinical phenotype of BAP1-TPDS is important for proper counseling and management of patients.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet any of the following criteria:

1. Personal history of one cancer reported in BAP1 cancer predisposition syndrome and family history of at least two 1st or 2nd degree relatives with cancer reported in hereditary BAP1 cancer predisposition syndrome such as UM, CM, mesothelioma, RCC, cholangiocarcinoma, meningioma and hepatocellular carcinoma.
2. Any patient with personal history of at least 2 cancers reported in hereditary BAP1 cancer predisposition syndrome.
3. Any subject (affected or unaffected) with a documented BAP1 pathogenic/ likely pathogenic variant.
4. Any patient with a cancer reported in BAP1 and a germline variant of uncertain significance.
5. At risk relatives of a patient with documented BAP1 mutation.

Exclusion Criteria:

* Study material including consent forms are currently only available in English so non-English speaking subjects are excluding
Risk of Cancer Among Pantoprazole Users

The primary objective is to assess whether the risk of gastric cancer is increased in pantoprazole users compared to users of other proton pump inhibitors.

All subjects who met the inclusion criteria were included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have used pantoprazole or other proton pump inhibitors, enrollment in the health maintenance organization for at least 6 months, age 18 years or older.

Exclusion Criteria:

* Use of any proton pump inhibitor before study entry, any cancer diagnosis recorded in the medical history, diagnosis of Zollinger-Ellison Syndrome in medical history.
Transvaginal vs Transabdominal Ultrasound Guided Embryo Transfer

Embryo transfer is the last step in the IVF process. it is now recognized that this step should be done carefully and that it affects success rates. in recent years, sonographic guidance appears to increase success rates.

Embryo transfer is the last step in the IVF process. it involves the insertion of a soft catheter through the uterine cervix. It is now recognized that this step should be done carefully and that it affects success rates. The embyos should be carefully deposited in the cavity. special care should be given to avoid touching the uterine fundus during the procedure. In recent years, sonographic guidance appears to increase success rates.

Eligibility Criteria:
Inclusion Criteria:

* high quality embryos fro transfer

Exclusion Criteria:

* repeated IVF failure
Diabetes Prevention Program Feasibility Study of Breastfeeding

The purpose of this study is to learn about the impact of the Diabetes Prevention Program (DPP) coupled with intensive breastfeeding support to help overweight or obese pregnant women lose weight postpartum, improve their blood sugars and blood pressure, and increase duration of breastfeeding their infant.

This pilot randomized controlled trial seeks to determine the feasibility and efficacy of a combined breastfeeding, DPP-based program in a cohort of overweight/obese women to be followed during pregnancy through 6 months postpartum. The pilot trial will have three study arms: DPP + breastfeeding (Tx1), DPP only (Tx2), and usual care (Tx3). Specific aims are: 1) To test the efficacy of Tx1 to improve 6-month postpartum weight loss among women with a BMI \>/= 25. 2) To test the efficacy of Tx1 to improve 6-month postpartum mean blood glucose (HbA1c) and mean arterial blood pressure among women with a BMI \>/= 25. 3) To test the efficacy of Tx1 to increase any breastfeeding through 6 months postpartum among women with a BMI \>/= 25.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant, 1st trimester or early 2nd trimester
* Interested in breastfeeding
* BMI \>/= 25 and \<35
* Able to read and understand English
* Able to learn and use Facebook
* Able to learn and use Skype, FaceTime or Zoom for virtual meetings
* Must have a cell phone

Exclusion Criteria:

* Pregnancy complications that require emergency care
* Thyroid disease
* Multiple gestation
* Substance abuse within last 3 years
* ART (Assisted Reproductive Technology) pregnancy
* Current smoker
* Prior bariatric surgery
* In weight-loss program within 3 months of conception
* BMI \>/= 35
* Unable to attend intervention / follow-up visits
* Unwilling to self-monitor data collection
* Unable to complete intervention
* Presence of any condition that limits walking
* Presence of any condition that limits following diet recommendations
* Pregnancies complicated with fetuses diagnosed with lethal malformations / conditions
Clemastine Treatment in Individuals With Williams Syndrome

This study explores the neurobiological etiology of Williams syndrome and potential therapeutic targets for associated social, motor, and cognitive abnormalities. The main translational objective will be to test the effectiveness of Clemasntine on neurocognitive and other associated abnormalities in individuals with Williams syndrome.

The overarching aim of the research proposed is to examine the safty of Clemastine use for individuals with Williams syndrome. Further, we wish to examine the relationship between Clemastine treatment and cognitive, motor and behavioral deficits in individuals with Williams syndrome. This study is an open-label study with a blinded randomize withdrawal. Each participant will go through a baseline evaluation (see study outcomes) and will be treated with the FDA approved drug Clemastine, in an age dependent dose (dosage table below). After a substantial improvement will be noticed, the participants will be divided into 2 groups, in a randomized, double-blind, placebo-control study design.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with Williams syndrome, which has been confirmed by genetic testing.
* Ages 6-30.
* Normal values in safety variables (e.g. Normal ECG 120-129/80-84).
* No change in psychotropic medications and dosage during the last 4 weeks.
* During the study, no pharmacological change that may impact the study (e.g. ADHD
* medications).

Exclusion Criteria:

* Individuals with another genetic disorder besides Williams syndrome.
* Individuals with Williams syndrome, younger than 6 or older than 30 years old.
* Significant change in normal values in safety variables (e.g. high or low ECG).
* Change in medications and dosage during the last 4 weeks prior the beginning and
* during the study.
* Pregnancy.
* Using addictive substances such as alcohol.
The Footwork Step Technique in Flamenco Dancing

A professional flamenco dancer will perform a ZAP 3 test, a sequence of single strikes of the feet performed continuously for 15 sec. Kinetic and kinematic studies will be recorded during the performance.

Flamenco is a highly emotional and sensitive dance, which is one of the most characteristic elements of Spanish culture. It is both physically and mentally demanding, with the emphasis on footwork technical execution and the aesthetic of arms and trunk movements. Years of training are necessary to achieve any level of proficiency as professional flamenco dancer.

Therefore proper execution of the movements minimize the risk of injury accompanying foot - ground contact which was reported by several studies. The most suffering parts of the dancer's body are the cervical and lumbar spine, knee and foot.

Despite the growing number of studies on flamenco dancing, there is a lack of investigations focused on understanding how does the flamenco dancer's body work to mitigate an injury risk. Therefore, the purpose of this study is to examine the parameters related to this issue: vertical Ground Reaction Force, Centre of Mass displacements and knee joint kinematics of the supporting leg They will be registered and analyzed during footwork performance.

A female professional flamenco dancer will perform a footork test called ZAP-3. It is a sequence of single strikes of the feet performed continuously for 15 seconds as fast as possible. 3D lower extremity kinematic data is used to collected using a five-camera motion analysis system (Vicon; Oxford Metrics Ltd., Oxford, UK). Kistler force platform will use to record the Ground reaction forces .

Eligibility Criteria:
Inclusion Criteria:

* Volunteer
* More than 15 years as proffesional flamenco dancer.
* More than 20 hours per week dancing flamenco

Exclusion Criteria:

* Not report any musculoskeletal or sub-acute injury prior to 12 months of the study.
* Not report any surgical intervention prior to 12 months of the study.
Adapted Fencing in Breast Cancer: a Pilot Study

Literature have shown the benefit of practicing regular physical activity during and after cancer treatment, particularly in terms of improving quality of life. The French Fencing Federation has thus developed an adapted physical activity program (Solution RIPOSTE) specially intended for patients with breast cancer. Adapted fencing sessions (saber) are thus offered to these patients in a perfectly secure context (i.e. compulsory medical-sports evaluation and trained fencing master). Since 2016, this RIPOSTE program has been implemented in several fencing halls in Lorraine. Our research project (controlled, randomized trial) aims to assess the impact of the practice of adapted fencing on the quality of life of patients, the functional capacities of the operated side (shoulder) and on the reduction of the sides effects of treatments. Our hypothesis is that such an adapted fencing program improves quality of life as well as functional abilities.


Eligibility Criteria:
Inclusion Criteria:

* Be a woman
* ≥ 18 years old.
* Have undergone unilateral breast surgery for primary invasive breast cancer
* Time between surgery and inclusion between 2 to 4 weeks after surgery
* Accept and be able to complete self-administered questionnaires
* Satisfy the prior medico-sports evaluation
* Be affiliated to a social security scheme or beneficiary of such a scheme
* Have received full information on the organization of the research and have signed their informed consent.

Exclusion Criteria:

* Presence of bone metastases, especially vertebral
* Presence of a contraindication to the practice of fencing during the medico-sports evaluation (post-surgery period that is too painful and / or requiring specific treatment in rehabilitation)
* Refusal to participate in the study
* Woman of childbearing age who does not have effective contraception.
* Persons referred to Articles L.1121-5, L.1121-7 and L. 1121-8 of the Public Health Code
* Pregnant woman, parturient or nursing mother
* Minor (non-emancipated)
* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
* Person of full age unable to express consent
* Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1.
Open-label Ziprasidone Study for Psychosis Treatment in Adolescents

This open-label study will assess the medication Geodon® (Ziprasidone) in pediatric patients, aged 13-17, diagnosed with psychotic disorder. Eligible adolescents will receive Geodon® for 7 weeks and stay at the NYSPI Children's Day Unit (CDU) during the day. If clinically appropriate, they may also stay at the New York State Psychiatric Institute (NYSPI) Schizophrenia Research Unit (SRU) inpatient facility.

This study is an open-label assessment of the feasibility of treating adolescents with psychotic disorders (schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified \[NOS\], major depressive disorder with psychotic features, and bipolar disorder with psychotic features) in an inpatient and day hospital setting with ziprasidone (Geodon). Ziprasidone is a second-generation antipsychotic (SGA) that is FDA-approved for the treatment of schizophrenia and for the treatment of the manic phase of bipolar disorder in adults. It is also used clinically in the treatment of psychotic disorders in children, adolescents and adults. This protocol will help to elucidate the feasibility of studying the treatment of psychotic disorders with ziprasidone in adolescents 13-17 years and help facilitate the further study of the treatment of psychosis with novel agents that have a favorable side effect and weight gain profile.

The duration of the study can be up to 7 weeks. Depending on the level of symptom severity patients will be managed on either the Schizophrenia Research Unit (SRU) (GAS\<35, CGI-S\>5), or the Children's Day Unit (CDU) of the NYSPI. The seven weeks would encompass a 3 day period at the beginning of the study including time for screening and reviewing lab results. Over a period of one to two weeks patients will be titrated up to 120 mg/day (80 mg for patients under 45kg), and, if necessary, cross tapered off of another SGA that had not been working successfully. Subjects who do not respond to the medication after 1 week at the target dose will be discontinued from the study.

Eligibility Criteria:
Inclusion Criteria:

1. Children who meet DSM-IV criteria for the following psychotic disorders: schizophreniform disorder, schizoaffective disorder, psychosis NOS, major depressive disorder with psychotic features, and bipolar disorder with psychotic features.
2. Children with an IQ of at least 70.
3. Children who are in good physical health.
4. The parent/guardian of the child must be willing to attend all study visits.

Exclusion Criteria:

1. Children who are currently receiving an effective treatment without detrimental side effects.
2. Children who are allergic to Geodon®.
3. Children who have previously failed to respond to an adequate trial of Geodon®.
4. Females who are pregnant or breast-feeding.
Role of Altered CD40-Ligand Gene Transcription in Systemic Lupus Erythematosus

Systemic lupus erythematosus is an often devastating autoimmune disease which affects 1 in 2,000 women in the United States. Recently, several research laboratories have reported that a protein, named CD40-ligand (CD154), is overexpressed by a subset of white blood cells, called lymphocytes, in patients with lupus. Expression of CD154 appears critical to the generation of antibodies that cause disease in lupus. Blocking CD154 interactions in the immune system has been shown to decrease disease activity in animal models of lupus. We propose to study the regulation of CD154 in patients with lupus in hopes of inhibiting its abnormal and deleterious expression.


Eligibility Criteria:
Inclusion:

A diagnosis of systemic lupus erythematosus
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft

The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae), L2 and below.

The primary endpoint will be the assessment of fusion by evaluation of x-rays taken following surgery at each visit. The x-ray evaluation will be conducted by a radiologist who is blinded to the type of treatment each patient has received.

Subjects will be seen at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative (post-op). Questionnaires and x-rays will be completed at each visit and a computed tomography (CT) scan will be taken at the 12 month visit(and used to aid in assessment of bridging bone, where appropriate).

Autograft (bone taken from one part of the body and placed in another site on the same individual) has long been considered the gold standard for lumbar spine fusion procedures. Unfortunately, there are complications involved with autograft harvest such as donor site morbidity, increased operating time, and limited supply. Therefore, the use of allograft (bone taken from one body and placed into another individual) as a graft extender has become an acceptable practice, especially in fusions of more than one level where larger quantities of graft material are needed.

In this study, comparisons will be made between patients who are randomized to having fusion with an allograft material (Optecure, Exactech, Inc.) mixed with an autograft to those patients who are randomized to having fusion with autograft alone.

Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated for primary lumbar fusion of 1 or 2 segments, L2 to S1
* Patient is willing to be blindly randomized to treatment or control and remain blinded for 2 years of follow-up
* Patient is at least twenty-one (21) years of age
* Patient is expected to survive at least 2 years beyond surgery
* Patient is willing to participate by complying with pre- and postoperative visit requirements, including: completion of questionnaires, functional performance tests, and radiographs/CT scan
* Patient is willing and able to review and sign a study Informed Consent form

Exclusion Criteria:

* Patient has a mental or physical condition that would invalidate evaluation results
* Patient is pregnant
* Patient is a prisoner
* Patient has a systemic infection or infection at the proposed surgical site
* Patient has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
* Patient has a disease of bone metabolism
* Patient is undergoing chemotherapy or radiation treatment
* Patient is currently involved in a study of another product for a similar purpose
* Patient requires post-op management with nonsteroidal anti-inflammatory drugs (NSAIDs)
Evaluation of Hospital Readmissions Among Hospitalized Non-valvular Atrial Fibrillation (NVAF) Patients in the US

The overall objective of this proposal is to execute a real-world database analysis to evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF) patients in the U.S

Primary objective: To determine the proportions of NVAF patients with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with the new oral anticoagulants (NOACs), dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting

Secondary objectives:

* To determine the cost associated with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting
* To determine the proportions of NVAF patients with all cause hospital readmissions and the associated costs that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting.


Eligibility Criteria:
Inclusion Criteria:

* Have a primary or secondary diagnosis of AF identified by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes from the Premier Hospital database between January 1, 2012 and December 31, 2013
* Age 18 years or older as of initial hospitalization with AF diagnosis

Exclusion Criteria:

* Have any primary or secondary diagnosis code or procedure code for valvular disease during the study period. This exclusion criterion is consistent with that used in other previous BMS HEOR studies and is used to ensure that the study populations are NVAF patients
* Received multiple types of NOACs during the index hospitalization. Preliminary analysis showed that very few patients receive multiple types of new oral anticoagulants (NOACs) during the same hospitalization. This exclusion criterion will allow to cleanly group patients into the different NOAC usage groups