cyrilzakka/clinical-trials huggingface dataset:
Satiating Diet, Appetite Control and Body Weight Loss in Individuals With Obesity

The objective of this study is to evaluate (1) the effect of a non-restrictive satiating intervention on appetite control, body weight loss and maintenance; and (2) determine whether switching to a non-restrictive satiating intervention following a conventional restrictive intervention can prevent increases in appetite and attenuate body weight regain usually observed after weight loss in men and women living with obesity. This is an 18-month, randomized, controlled, parallel weight loss \[Phase 1 (P1): 6 months\] and maintenance trial \[Phase 2 (P2): 12 months\] with three groups (n=234 men and women): (1) non-restrictive, satiating intervention (P1) followed by a continuation of this intervention (P2); (2) conventional restrictive intervention (-500 kcal/d) (P1) followed by a non-restrictive satiating intervention (P2); (3) control group that follows minimal healthy guidelines (P1) followed by recommended weight maintenance strategies (P2). All groups will be controlled for physical activity and sleep patterns. The non-restrictive satiating intervention will include guidelines and recipes to prepare highly satiating meals that will be low in energy density and glycemic index and high in protein, polyunsaturated fats, vitamins and minerals (e.g. calcium), and certain constituents of spices (e.g. capsaicin). Measurements at baseline (week 0), after P1 and P2 will include the following primary outcomes: appetite control, weight loss and maintenance; and secondary outcomes: body composition, physiological, psycho and neurobehavioural and health-related variables. Follow-ups will be done by a dietitian every 2 weeks during P1 and once a month during P2.


Eligibility Criteria:
Inclusion Criteria:

* individuals with a BMI ≥30 and \<40 kg/m2
* aged between 18-50 years
* waist circumference \>102 cm in men and \>88 cm in women.

Exclusion Criteria:

* taking medications that could influence appetite or body weight (e.g. thyroid replacement therapy, sulfonylureas and glucocorticoids)
* being treated with insulin for type 2 diabetes
* large body weight fluctuations (\>4 kg over last two months)
* characterized by high restraint behaviour (score \>12, measured with the TFEQ)
* history of an eating disorder (e.g. binge eating disorder) using the EDE questionnaire
* performing \>150 min of moderate-vigorous intensity physical activity/week
* use of nutritional supplements (multivitamins, calcium, protein, fibre); 8) smoking, drugs or alcohol (\>2 drinks/d)
* consumption of \>5 cups of coffee/d
* (pre)menopausal or pregnant women
* diagnosis of chronic diseases, acute infections or gastric problems (e.g. ulcers)
* food allergies/intolerances to ingredients/foods in the satiating intervention
* having a pacemaker (for fMRI)
* taking sedatives or sleeping pills
* symptoms of depression (\>20 on the BDI).
Superficial and Deep Endometriosis: Role of Systemic Inflammation as a Marker of Clinical, Surgical, and Reproductive Outcomes

Primary aim of this study is to evaluate the change in systemic inflammation parameters after surgery for superficial, ovarian or deep endometriosis. Secondary objectives focus on correlating these parameters to clinical outcomes, in patients with pelvic pain, and reproductive outcomes, in women desiring offspring.

Participants already scheduled for surgery as part of their endometriosis care will be followed regarding the abovementioned outcomes after calculation of pre and postsurgical systemic inflammation markers (neutrophil to lymphocyte ratio; platelet to lymphocyte ratio and lymphocyte to monocyte ratio)


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45 years.
* Postoperative follow-up of at least 12 months;
* Signature of informed consent regarding laparoscopic surgical treatment.
* Signature of informed consent to the processing of personal data duly documented by medical records.

Exclusion Criteria:

* Failure to sign informed consent for laparoscopic surgical treatment
* Histologic diagnosis of borderline tumor and/or ovarian carcinoma and/or mucinous cystadenoma and/or germ cell tumor or other malignancy of the genital tract
* postoperative follow-up of less than 12 months;
* documented history of inflammatory, rheumatologic, or immunologic disease; and
* failure to provide informed consent for personal data processing.
New Technique as an Additional Diagnostic Tool for Women Undergoing Neoadjuvant Therapy for Breast Cancer

Molecular Breast Imaging is a highly promising novel methodology for breast cancer detection. Preliminary patient studies with our dual-detector system indicate that this system is capable of reliably detecting very small (5-10 mm) malignant lesions in the breast. Besides the usefulness of Molecular Breast Imaging for tumor detection, we speculate that tumor uptake and washout may be predictors to response to neoadjuvant therapy for patients with the diagnosis of breast cancer. We propose that in patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy that molecular breast imaging is an accurate test for assessing response rate to neoadjuvant therapy.

Adjuvant therapy after surgery for breast cancer has provided significant benefits to patients at risk for relapse. However, the success of therapy for each individual patient will often take years to reveal. Preoperative (neoadjuvant) medical therapy is very potent as an initial treatment for inoperable and large operable breast cancers. Tumor regression can be achieved in the great majority of patients and downstaging frequently reduces the need for mastectomy and it has become clear that pathologic complete response is a good prognostic marker. Data from current trials suggest that survival is at least as good with preoperative as with postoperative neoadjuvant therapies (1). With this observation preoperative medical therapy has the advantage over post-operative neoadjuvant therapy that it can be used as a short term surrogate marker for long-term outcome. With this translational approach, the therapy for each patient can be more targeted and individualized leading to higher success rates; and further, new therapies for early breast cancer can be assessed much more quickly than is currently possible through protracted trials of neoadjuvant therapy (2). This approach is therefore being increasingly utilized in patients with lower stage breast cancers.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18 - 90
* Women with breast cancer scheduled to undergo neoadjuvant chemotherapy therapy or neoadjuvant hormone therapy
* Women who have undergone any breast imaging procedure, and in whom a repeat imaging procedure is planned prior to definite surgery

Exclusion Criteria:

* Pregnant or lactating
* Unable to understand or sign a consent form
* Physically unable to sit upright and still for 40 minutes
Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)

The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a Rituximab induction therapy.


Eligibility Criteria:
Inclusion Criteria:

* B-CLL
* Age \>18
* ECOG performance status 0-2
* Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line
* Patient must be in complete remission or partial remission after an induction treatment containing rituximab
* ANC (absolute neutrophil count) \> 1,0 x 10e9 /L
* Life expectancy \> 6 months
* Patient´s written informed consent
* Patient using a reliable means of contraception for the duration of the treatment including 2 months thereafter

Exclusion Criteria:

* Active uncontrolled bacterial, viral or fungal infection
* Significantly reduced organ functions and bone marrow dysfunction not due to CLL
* creatinine clearance of below 30mL/min
* Patients with a history of other malignancies within 2 years prior to study entry
* Patients with a history of severe cardiac disease
* Other known comorbidity with the potential to dominate survival
* Transformation to aggressive B-cell malignancy
* Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
* Medical condition requiring prolonged (\> 1 month) use of oral corticosteroids
* Pregnant or breast feeding women
* Any coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
The Inside Study II: Oligosaccharides Versus Placebo and Hard Stools

In the present randomised double blind controlled study, we will study the effects of a oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with hard or lumpy stools.

Firm, hard or lumpy stools can be problematic for young children and might come as a precursor of functional constipation in childhood. The cause of harder stools in childhood is incompletely understood. But it is likely that harder stools in childhood are linked to among others withholding behaviour of stools and a low fibre intake. As hard stools may precede functional constipation, the aim of the study is to investigate the effect of a prebiotic fiber versus a placebo on defecation parameters in healthy children with hard or lumpy stools. We hypothesize that consumption of a prebiotic fiber results in softer stools.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* aged 1-4 years
* Hard and/or firm stools as scored by a stool questionnaire

Exclusion Criteria:

* Children that meet the Rome IV criteria for functional constipation
* Children who suffer from any other GI complaints, known structural GI abnormalities, or previous GI surgery
* Any condition that would make it unsafe for the child to participate.
* Children with clinically significant cardiac, vascular, liver, pulmonary, psychiatric disorders, severe renal insufficiency, human immunodeficiency virus, acquired immunodeficiency syndrome, hepatitis B or C or known abnormalities of haematology, urinalysis, or blood biochemistry, as checked by the inclusion questionnaire.
* Children who are allergic to cow's milk or fish
* Use of antibiotics or other medicines or food supplements, and breast milkfeeding, which can influence defecation and gut microbiota 4 weeks prior to the study
* Children that participate in another clinical trial
Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis

The aim of this clinical trial study is to compare the efficacy of Hyaluronic injection in patients with symptomatic knee osteoarthritis. The main questions it aims to answer are:

* Is Hyaluronic acid injection improve pain symptom, joint stiffness, and joint function in patients with knee osteoarthritis
* Is Hyaluronic acid injection improve knee performance status and health-related quality of life in patients with knee osteoarthritis

Participants will be allocated to receive one treatments; either Hyaluronic acid or normal saline injections after receiving glucocorticoid injection.

Researchers will compare the Hyaluronic acid with normal saline injection to see if the former show superior effect in terms of pain, joint stiffness, function, as well as health-related quality of life comparing with placebo.

Participants who had been diagnosed with knee osteoarthritis according to American College of Rheumatology (ACR) criteria will be enrolled in this study. After the participants receive the information and consent to participate in this study, they will be examined their affected knee by the co-researchers. Ten-milligrams of Triamcinolone will be injected intra-articular into knee joint.

Two-to-four weeks later, the participants will be evaluated for knee pain, stiffness, function and quality of life, as well as knee performance status. Participants whose their knee joint absence of effusion will be allocated in to one treatment group; either Hyaluronic acid or normal saline. After injection, participants will be scheduled for the follow-up visit in 12 and 24 weeks later. In each follow-up visit, they will be evaluated for joint pain, stiffness, function and quality of life, as well as analgesic use and adverse reaction form treatment.

Eligibility Criteria:
Inclusion Criteria:

* All participants who had been diagnosed as knee osteoarthritis according to ACR criteria with symptom of knee pain
* Pain visual analog scare of 4 or higher

Exclusion Criteria: Participants who have

* Cognitive impairment
* History of aller to Hyaluronic acid or its component
* History of knee arthropathy
* Concomitant with inflammatory arthritis
* Serious comorbidities or bedridden status
* Current pregnancy or lactation
* Currently use of symptomatic slow acting drugs for osteoarthritis (SYSADOA)
* Communication problem
To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults

The purpose of this phase II study is to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression.

This is an open-label, Phase II study to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression. In this study, approximately 29 subjects will be enrolled to receive one of the two UB-421 regimens as the monotherapy in replacement of HARRT treatment. Subjects assigned to Cohort 1 will receive UB-421 infusion at 10 mg/kg weekly for 8 weeks; subjects assigned to Cohort 2 will receive UB-421 infusion at 25 mg/kg bi-weekly for 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 sero-positive
* Aged 20 years or older
* Have received HAART treatment
* CD4+ T cell count ≧ 350 cells/mm3
* HIV-1 plasma RNA level remains below the limit of
* Were not breastfeeding for women
* Subjects with a negative serum pregnancy test result at screening visit for women of childbearing potential
* Subjects agree on using birth control barrier (female or male condom) during the entire study period
* Subjects sign the informed consent before undergoing any study procedures

Exclusion Criteria:

* Any active infection except for HIV, and required immediate therapy
* Any active AIDS-defining illness per Category B and Category C conditions according to the U.S. Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection
* Any documented CD4+ T cell count \< 200 cells/mm3 within the past 12 weeks before screening visit
* Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history, and/or physical examination that, in the investigator's opinion, would preclude the subject from participating in this study
* Any vaccination within 8 weeks prior to the first dose of study drug
* Any immunomodulating therapy (including interferon and steroid) or systemic chemotherapy within 12 weeks prior to the first dose of study drug
* Any illicit intravenous drugs within 12 weeks prior to the first dose of study drug
* Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
* More than one change of HAART regimen because of virologic failure
Inspiring New Science In Guiding Healthcare in Turner Syndrome Registry

INSIGHTS is a registry research study that collects key information on medical history for girls and women with Turner syndrome and the clinical care they receive. This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. In addition to learning a lot about the current state of health for individuals with TS, INSIGHTS serves as an infrastructure to conduct future studies are meaningful to patients and their families.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals with TS and TS variants as defined by the TS Clinical Practice Guideline definition (karyotype consistent with TS, phenotypic female, clinical feature(s) of TS)
2. Informed consent/assent as appropriate

Exclusion Criteria:

a. Lack of a TS diagnosis on file
Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury

The purpose of this study is to develop and field-test new tools for diagnosis and hazard assessment of cardiometabolic risk (CMR) in people with chronic spinal cord injury (SCI) and to advance the evidence base with much needed information on CMR and cardiovascular disease (CVD) burden in people with SCI. These data can be used to develop screening guidelines for early identification and prevention of CMR in SCI, as well as targeted approaches to primary disease management.

Unlike current assessments utilizing lipid scores, the new system will be anchored in more reliable measurements of cardiovascular disease (CVD) burden using contemporary surrogate end points of coronary artery calcium (CAC) score, coronary CT angiography and carotid intima media thickness (CIMT). By the end of the 5-year funding cycle we will develop an updatable web-based cardiometabolic risk assessment tool (RISK) that will allow clinicians and SCI consumers to quantify risk for a cardiovascular sentinel event (stroke, non-fatal heart attack, or death) and will also provide a body mass index (BMI) table adjusted for SCI.

Specific Aims:

1. Examine the relationships among surrogates of cardiovascular disease burden in persons with SCI and established cardiometabolic risks.
2. Identify significant predictors of cardiometabolic risk (CMR) that are unique to persons with specific levels of SCI.
3. Develop and validate SCI CMR assessment tool (RISK) based on cardiometabolic risk scores.
4. Develop and validate an adjusted BMI table for SCI.

Eligibility Criteria:
Inclusion Criteria:

* traumatic spinal cord injury between C4 and T12
* have a motor complete injury as classified as American Spinal Injury Association Impairment Scale (AIS) grade A or B
* injury for more than 1 year
* no known history of traumatic brain injury, cardiovascular disease or diabetes
* not currently taking any medications to treat cardiovascular disease or diabetes
* have multiple (i.e., 2+) of the following cardiometabolic risk factors:

  1. fasting triglyceride \> 150 mg/dL
  2. HDLC \< 40 mg/dL
  3. hs-CRP \> 3.0
  4. body fat (by DEXA) \>25% for males and 33% for females

Exclusion Criteria:

* history of allergy or hypersensitivity to fish and/or nuts
* undergoing anticoagulant therapies
Prolene Versus Ethibond for Cervical Cerclage

The purpose of the proposed study is to examine the relationship between cerclage suture material of Ethibond and Prolene and its effect on the vaginal microbiome in a prospective randomized control trial. Ethibond is another commonly used suture material for performing cervical cerclage that shares some characteristics with previously studied suture materials. It is braided like the Mersilene, but thinner like the monofilament Prolene. The investigators will study whether Ethibond causes the vaginal microbiome to be adversely affected like Mersilene or whether there is a healthy microbiome like Prolene. This study will allow the investigators to determine whether it is advisable to continue to use Ethibond for cervical cerclage in clinical practice, or whether obstetricians should avoid its use as now done with Mersilene.


Eligibility Criteria:
Inclusion Criteria:

* Greater than18 years of age
* Singleton pregnancy
* History of preterm delivery between 17 0/7 weeks - 33 4/7 weeks with painless cervical

dilation or cervical insufficiency

Exclusion Criteria:

* younger than 18 years of age
* multiple gestation
* iatrogenic preterm delivery
* pregnancies with fetal anomalies
Slow Digestible Carbohydrates and Exercise in Adolescents with Type 1 Diabetes

In this within-subject cross-over study, the investigators hypothesize that corn-starch based supplements taken prior to exercise will decrease the risk of delayed hypoglycemia in adolescents with T1D, improve performance during exercise, and decrease glycemic variability during exercise.

Type 1 diabetes (T1D), one of the most common chronic diseases in adolescents, is caused by the destruction of insulin producing beta cells which are located in the pancreas. There are many factors that impact diabetes control which are insulin administration, intake of food and exercise. When an individual exercises, weight is better managed which allows for a better cardiovascular system. Exercising also improves insulin sensitivity which can increased the risk for delayed hypoglycemia (low blood sugar). Many individuals with T1D do not participate (or under-participate) in exercise due to the fear of hypoglycemia. This study will recruit adolescents with Type 1 diabetes to undergo a maximal exercise test to determine their VO2max. Study participants then will complete 2 exercise performance tests prior to which the participant will be randomized to consume 22 grams of either fast acting carbohydrates or long-acting cornstarch based supplements. Subjects will be asked to bike for 45 minutes (at 50% of VO2max) and then complete a 3.75 mile bike ride as quickly as possible. The investigators will document the time to completion of the bike ride as well as monitor glucose levels via continuous glucose monitoring for 12 hours after completion of the exercise test.

Eligibility Criteria:
Inclusion Criteria:

* Age 12 - \<18 year old male and female subjects with Type 1 diabetes for \> 1 year
* HbA1c \<10.5%
* Body Mass Index \>10th % and \<95th%
* Not being treated with sensor-augmented pump therapy
* Ability to participate in exercise activity - biking
* Willing to wear a continuous glucose monitor (CGM) sensor

Exclusion Criteria:

* Severe hypoglycemia (requiring glucagon or external assistance) in last 6 months
* Admission for diabetic ketoacidosis in last 3 months
* History of chronic lung disease, congenital heart disease or chronic asthma
* Food (including corn)/dye allergies
* Other chronic medical conditions except for well-controlled thyroid disease