cyrilzakka/clinical-trials huggingface dataset:
Dietary Phytoestrogens and Bone Metabolism

The purpose of this study is to determine whether dietary phytoestrogens are an effective alternative to postmenopausal exogenous estrogen replacement therapy in preventing bone loss.

Osteoporosis in postmenopausal women is one of the most important public health challenges of our time. With millions of women affected and billions of dollars being spent for its complications, we need to develop effective approaches to this disease. Postmenopausal women are at particular risk because the loss of estrogen associated with the menopause leads to bone loss of much greater magnitude than one would expect on the basis of age alone. Estrogen replacement therapy, a logical and effective therapeutic approach, has been associated with serious concerns about adverse events and, thus, limited use. The recent development of selective estrogen receptor modulators (SERMS) may help if they continue to show promise. Interest in natural sources of estrogenic substances to prevent postmenopausal bone loss is an expected outgrowth of the general interest in alternative medicinals for a wide variety of human disorders. Concerns about the potential for adverse consequences of the conventional use of estrogen replacement therapy, and limited knowledge about long term use of SERMS- add support to this quest. No systematic investigation of the role of dietary phytoestrogens on bone mass and skeletal dynamics has yet been conducted. With the dramatic increase in interest in these sources of estrogenic activity, it is important for us to determine whether these agents are efficacious. Otherwise, this field will be plagued for years to come by incomplete, anecdotal and scientifically poorly documented actions of these agents on bone metabolism. It is our expectation that this study will begin to provide the documentary information that the field so clearly needs. The rationale for exploring the potential for phytoestrogens in the maintenance of skeletal health in postmenopausal women is clear and compelling.

Women will be randomly assigned to one of three healthy eating plans and, over the course of the year-long study, will learn to choose and cook foods to help optimize health as they go through menopause and beyond.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal
* Weight within 90% to 120% of ideal body weight
* 12 or more months since last menstrual period
* New York Metro Area resident

Exclusion Criteria:

* History of cancer, diabetes, or heart disease
* Smoker
99mTc-MIRC208 SPECT/CT Imaging for HER2-Positive Cancer Patients

This is an open-labeled Single-Photon Emission Computed Tomography/Computed Tomography(SPECT/CT) study to investigate the clinical value of 99mTc-MIRC208 in HER2 status measurement of cancer patients. A single dose of 14.8 MBq/kg body weight will be injected intravenously. The whole-body SPECT/CT examination will be performed 2 h post-injection and the visual and semiquantitative methods will be used to assess the SPECT/CT images.

HER2 is an important therapeutic target for cancer. Immunohistochemistry(IHC) and fluorescence in situ hybridization (FISH) are two standard approaches for HER2 status determination and selection of patients who will undergo the anti-HER2 therapy. However, the intra- and intratumor heterogeneity over space and time make them even more challenging to assess HER2 status. HER2-specific nuclear molecular imaging is a potential tool, which has ability to detect HER2 receptor in primary and metastatic lesions noninvasively and address the problems encountered by biopsy dependent tests. VHH, also referred to as nanobody, is a distinct type of antibody fragment derived from camelid heavy chain-only antibody. Compared with classical antibodies, VHHs have smaller size (about 15 kDa), greater thermal and chemical stability, which promoting their application in field of cancer theranostic.

In our recent preclinical studies, Principal Investigator developed a novel VHH-based radiotracer, 99mTc-MIRC208, for the SPECT/CT imaging of HER2 status in tumors. In this clinical study, Principal Investigator aim to investigate whether 99mTc-MIRC208 could be used for HER2 measurement in cancer patients. 99mTc-MIRC208 SPECT/CT examination will be performed in patients with HER2-positive tumors. The SUV of 99mTc-MIRC208 in tumors will be calculated. Meanwhile, Principal Investigator will investigate the ability of 99mTc-MIRC208 for the patients selection for anti-HER2 therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Aged # 18 years old; ECOG 0 or 1;
2. Patients with HER2 positive or suspicious positive tumors;
3. Has at least one measurable target lesion according to CT or MRI;
4. Life expectancy ≥ 12 weeks.

Exclusion Criteria:

1. Significant hepatic or renal dysfunction;
2. Is pregnant or ready to pregnant;
3. Cannot keep their states for half an hour;
4. Refused to join the clinical research;
5. Suffering from claustrophobia or other mental disorders;
6. Any other situation that researchers considered it unsuitable to participate in the trial.
Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T

Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T. Enrolling subjects will be followed for a total of 12 years.

Subjects infected with HIV who have received therapy with SB-728-T or SB-728mR-T will be eligible to participate in this trial. There will be no treatment in this long-term follow-up study. Subjects who choose to enroll into this extension study will be evaluated for a total of 12 years.

Eligibility Criteria:
Inclusion Criteria:

Subjects who have, in previous Sangamo clinical trial received SB-728-T or SB-728mR-T, autologous T-cells genetically modified at the CCR5 gene by zinc finger nucleases and give consent to participate in the long-term follow-up study.

Exclusion Criteria:

There are no exclusion criteria for this study.
Skin Traction Versus Position Splint in Patients With Hip Fracture

The aim of this prospective, randomized controlled trial is to compare the effects of preoperative skin traction and position splint on pain, comfort, complications, difficulty level of nursing interventions, satisfaction from treatment and nursing care in patients with hip fracture. The sample is comprised of 34 patients with hip fracture in each group, totally 68 patients. Skin traction and position splint were applied after block randomization. Data regarding pain, comfort, satisfaction from care, immobilization comfort, complications, time of operation and hospitalization time were collected after intervention.


Eligibility Criteria:
Inclusion Criteria:

* Being inpatient who were planned the surgery due to the hip fracture (caput femur fracture, collum femur fracture, femur intertrochanteric fracture and subtrochanteric fracture) diagnosis in the Orthopedics and Traumatology Clinic
* Being 50 years old or more
* Patients who speak and literate in Turkish
* Patients who gave informed consent to participate in the study

Exclusion Criteria:

* Any condition that emerges an obstacle for verbal and written interaction during data collection phase
* Unable to perform written or verbal communication in Turkish
* Withdrawal from the study due to medical reasons or death, at his/her will prior to preoperative data collection
* Urgent non-elective surgery
* Physician decision that do accept the method of immobilization assigned to the patient as appropriate
Effect of an Oral Probiotic Tablet on Oral Bacteria and Clinical Measurements (ProBiora3)

The purpose of this study is to determine if an oral probiotic tablet taken once a day for twelve weeks can decrease the numbers of bacteria that are associated with tooth decay and gum disease in a dentally healthy, young adult population.

There are over 500 types of bacteria in the mouth. Most of these bacteria do not cause disease. However, some mouth bacteria can cause tooth decay and gum disease. The purpose of a probiotic tablet for the mouth is to put known healthy bacteria in the mouth. This study will compare the effect of the probiotic tablet on the levels of harmful or disease causing bacteria in the mouth to a placebo tablet that does not contain any probiotic bacteria.

Eligibility Criteria:
Inclusion Criteria:

* minimum of 20 teeth, with only a few fillings
* good general health
* willing to use an appropriate method of birth control during the study
* measurable levels of Streptococcus mutans and one or more of the selected periodontal pathogens

Exclusion Criteria:

* chronic or acute illness such as heart disease, diabetes, cancer, hepatitis (liver disease) or HIV positive
* radiation therapy or systemic cancer treatment (chemotherapy)
* require antibiotics for dental treatment
* pregnant or planning to become pregnant during the study period
Durability of Weight Loss After Bariatric Surgery

The present study is a retrospective cohort study. Patients older than 18 years of age and underwent Roux-en-Y gastric bypass (RYGB) surgical treatment during the period from 2014 to 2019 and paired severely overweight controls who had no longer gone through bariatric surgery. Patients having BMI (Body Mass Index) much lower than 35 (calculated as the weight (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical exclusion for surgical treatment died in one year of surgical operation and missed statistics at scientific information had been excluded from the study. The primary final results of the study was the weight-change percentage at follow-up in comparison with baseline one and the clinical events after surgery.

This is a retrospective cohort study. The sample size of our study includes one hundred case older than 18 years of age and underwent RYGB surgical treatment during the period from 2014 to 2019 and paired severely overweight controls who had no longer gone through bariatric surgery. Patients having BMI (Body Mass Index) much lower than 35 (calculated as the weight (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical exclusion for surgical treatment, died in one year of surgical operation and missed statistics at scientific information had been excluded from the study. Data was collected taking in to account each patient history (age, sex, length, weight, BMI, occupation, marital status, and comorbidities) and weight record in every visit from measurements statistics. Outcomes: The primary final results of the study was the weight-change percentage at follow-up in comparison with baseline one. The secondary effects including the clinical events after surgery, micronutrient levels, incidence of diabetes, hypertension, and dyslipidemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients equal or over 18 years old
* BMI more than 40
* Complete follow up

Exclusion Criteria:

* No complete follow up
* Age less than 18 or more than 80
PMCF Study on PEEK Suture Anchors for Shoulder Indications

Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have undergone shoulder joint repair using the study devices.
2. Subjects aged 18 years and older at the time of surgery.

Exclusion Criteria:

1. Subjects who are \< 12 months post-operative.
2. Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery.
Abdominal Wall Evaluation in Low Back Pain

The purpose of this study was to evaluate feed-forward contraction of the transversus abdominis and thickness of the transversus abdominis, obliquus internus, and obliquus externus during calm and standardized respiration in low back pain patients and pain-free subjects.

Low back pain patients have alterations in abdominal wall function, especially in the feed-forward activation of transversus muscle during limbs movements. However, there are no reports on the abdominal function in low back pain patients during physiological respiratory movement.

Eligibility Criteria:
Inclusion Criteria:

* For the low back pain group: women with history of non-specific chronic low back pain for more than three months
* For the pain-free group: pain-free women

Exclusion Criteria:

* For both groups were: pregnancy, neurological condition, obesity (body mass index: BMI \>30), or previous spine or abdominal surgery.
* For the low back pain group: rheumatology diseases other than low back pain.
* For the pain-free group: any rheumatology disease.
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)

The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1
* Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria
* PD-L1+ on immunohistochemistry testing performed by central lab
* Men and women, ages ≥ 18 years of age

Exclusion Criteria:

* Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy
* Known anaplastic lymphoma kinase (ALK) translocations
* Untreated central nervous system (CNS) metastases
* Previous malignancies
* Active, known or suspected autoimmune disease
Strong Fathers, Stronger Families Healthy Marriage and Responsible Fatherhood Program Evaluation

The purpose of this descriptive study is to explore whether there is an association between participation in the Strong Fathers, Stronger Families program and improvements in outcomes related to parenting, co-parenting, and economic stability. Participants are surveyed at program entry and program exit, and changes in participant attitudes are assessed over time.

This study is a descriptive evaluation of the Strong Fathers, Stronger Families program offered to fathers in the Memphis metropolitan area. Program participants are informed about the study and asked to provide consent to participate in the evaluation of the ten-week program. Consenting participants complete surveys at program enrollment and program exit, and survey data is used to determine if program participation is associated with short-term changes in attitudes and behaviors among participants. Changes in parenting, co-parenting, and economic stability outcomes are assessed by comparing survey answers before and after participating in 40 hours of the Blueprint and 24/7 Dad curricula.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 and older)
* With children ages 0-24
* Father/father figure
* Reside in Memphis metropolitan area

Exclusion Criteria:

* Minor (under the age of 18)
* Not a father/father figure
* Children older than 24 years old
* Reside outside of Memphis metropolitan area
Von Willebrand Factor As a Biological Sensor of Blood Flow in Percutaneous Cardiac Procedure

The WITAVI study was designed to explore the kinetic and associated outcome of Von Willebrand Factor-multimerizaton defects associated with devices in cardiovascular diseases.

This study was designed to understand the Von Willebrand Factor (VWF) abnormalities observed in association with implantation of different devices in cardiovascular diseases (percutaneous valve replacement and circulatory support devices).

The main objective of the study was to describe the time-course of VWF abnormalities onset/offset during implantation of devices in cardiovascular diseases.

Adult patients \> 18 years who need a CF-LVAD or trans-aortic valve implantation are included in this cohort; Blood samples are obtained just before procedures

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \> 18 years who need a mechanical circulatory support due to advanced heart failure or undergoing trans-aortic-valve-replacement to treat aortic stenosis.
* Informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)

Exclusion Criteria:

* Patient with a known severe bleeding disorder
* Patient refusal or environment
* Minor patients
* Pregnant women
Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease

Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai) with durable polymer, comparing with Excel SES.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* male or un-pregnant female
* stenosis \> 70% in one of major the epicardial coronary arteries
* no contra-indications of stent implantation
* singed the informed consent

Exclusion Criteria:

* acute myocardial infarction within one week
* have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy
* no history of stent implantation within last one-year
* received other brand coronary stent during index procedure
* with no achievement of informed consent
Role of SWE-change After TIPS in the Prediction of Prognosis After TIPS

The aim of our prospective multicenter study was to investigate the prognostic value of the acute and long-term changes of liver stiffness in patients receiving a transjugular intrahepatic portosystemic shunt (TIPS).

We included 83 patients receiving TIPS for prevention of rebleeding, therapy-refractory ascites or both. Hemodynamic parameters were assessed before TIPS and after TIPS insertion. 16 patients from Freiburg underwent TE immediately before and after TIPS. In 67 patients from Bonn, SWE of liver and spleen, as well as clinical and biochemical parameters were assessed before TIPS, seven days and six weeks after TIPS.

Eligibility Criteria:
Inclusion Criteria:

* TIPS insertion and had reliable SWE or TE measurement

Exclusion Criteria:

* contraindication for TIPS
* no reliable SWE or TE measurement
Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy

Primary Ciliary Dyskinesia associated with abnormalities of lateralization of organs (with existence of a situs inversus in 50% of cases) and secondary fertility disorders related in humans to abnormalities of mobility of sperm but very little data on the structure and function of tubal cilia in women

Primary Ciliary Dyskinesia (DCP) is a rare genetic disease (1 in 15,000 individuals at birth), which manifests itself in chronic respiratory infections (bronchopneumopathies and rhinosinusitis type) associated with abnormalities of lateralization of organs (with existence of a situs inversus in 50% of cases) and secondary fertility disorders related in humans to abnormalities of sperm mobility. However, there is very little data in the literature on the structure and function of tubal cilia in women with DCP.

Before considering a study of tubal cilia in patients with DCP, it seems necessary to specify in DCP patients or not DCP, the molecular and morphological composition of tubal cilia and to look for ciliary abnormalities in case of GEU

Eligibility Criteria:
Inclusion Criteria:

* Patients with scheduled salpingectomy (Ectopic pregnancy, hysterectomy for prolapsus, adenomyosis or myomectomy)
* Major patients ( \>18 years)

Exclusion Criteria:

* Patient not willing to participate in the study
Characteristics of the Intestinal Microbiota in Patients With Cancer

In order to understand how the intestinal microbiota plays a role in the effectiveness of an anti-cancer treatment by an immune control point inhibitor, this study aims to constitute a catalog of microbial genes of a patient with cancer. This catalog will help to characterize the intestinal microbiota of cancer patients and to be able to use this catalog as a reference tool for screening the microbiota of patients treated with immune control point inhibitors. To produce this catalog, five types of cancer were selected: non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, breast cancer and prostate cancer.

The metagenomic analysis of a group of five different types of cancers introduces a lot of heterogeneity which is favorable to the richness of a catalog. For non-small cell lung cancer treated with immune control point inhibitors, two stool collections will be performed per patient (one stool collection before setting up an immune control point inhibitor and one collection after one month of being inhibited Of immune control point) to assess the impact of the immune control point inhibitor on the microbiota (pilot study). For this study, two stool collection tubes containing different preservative solutions will be used (one RNAlater tube and one DMSO-EDTA tube for Dimethylsulfoxide-Ethylene diamine tetraacetic acid).

In parallel, we will also collect samples of serum and plasma to evaluate, in a second step, protein markers in circulating blood.

Primary objective: Develop a catalog of microbial genes dedicated to oncology (Onco catalog) by sequencing stool specimens from patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Men or women between 18 and 75 years of age.
* Patients with one of the following types of cancer: non-small cell lung cancer, hepatocellular carcinoma, colorectal cancer, breast cancer, prostate cancer and glioblastoma
* Patients with informed consent to participate in the study.
* Affiliation to the social security system

Exclusion Criteria:

* For patients with hepatocellular cancer, patients infected with the human immunodeficiency virus (HIV)
* Patients who are unable to understand, read and / or sign informed consent
* Patients who can not collect / send stools for geographical, social or psychological reasons
* Patients with previous cancer in the 5 years preceding this study
* Persons benefiting from a system of protection for adults (including guardianship and curatorship)
* Pregnant or nursing women
* Patients with another synchronous tumor
* Patients with fecal transplant
* Patients with chronic inflammatory bowel disease (IBD)
* Patients having had in the 3 months preceding the collection of stool: colonoscopy, bariatric surgery, surgical removal of a segment of the small intestine (enteritomy or enterostomy), parenteral nutrition.
* Patients who had had antibiotic therapy within 1 month before stool collection