cyrilzakka/clinical-trials huggingface dataset:
RFC1 Natural History Study

This international, multi-center, multi-modal and prospective observational study aims to determine the phenotypic spectrum and the natural progression of the RFC1 repeat expansion disease, and to seek and validate digital, imaging, and molecular biomarkers that aid in diagnosis and serve as outcome measures in future clinical trials of this novel, but frequent ataxia with late adult-onset.

The investigators will perform an international, multi-center, multi-modal, and registry-based standardized prospective Natural History Study (NHS) in RFC1 repeat expansion disease. Participants will be assessed annually. Study visits with a standardized clinical examination will apply several clinical rating scales, and data will be entered into a clinical database (ARCA Registry; www.ARCA-registry.org) customized to the requirements of this specific study. At all study visits, patients will be asked to donate biosamples; biomaterial collection is optional, and participants can elect to participate in sampling of blood, urine, CSF, and/or a skin biopsy.

Optionally, and depending on local availability at each participating site, additional examinations may be performed including imaging, quantitative movement and speech analysis, vestibular testing, a neuropsychological examination, or examination of swallowing function, all to fully capture the multisystemic presentation of the RFC1 repeat expansion disease.

This study will delineate variable phenotypes of this relatively novel disease, and systematically characterize the longitudinal progression of multi-model biomarkers to determine the most sensitive, comprehensive, and reliable outcomes measures for future therapeutic trials. Here, longitudinal validation of targeted fluid biomarker candidates will be an important part. The multi-modal longitudinal design of the study and its comprehensive assessment will also provide mechanistic insights into the multisystemic evolution of the disease, which will especially allow to track and understand selective as well as overlapping dysfunction of the cerebellum, sensory peripheral nerves, the vestibular system, and additional systems known to be involved in RFC1 disease or 'CANVAS' as its related syndrome.

Eligibility Criteria:
Inclusion Criteria:

* RFC1: genetic diagnosis of bi-allelic pathogenic repeat expansions in RFC1
* Unrelated healthy controls: no signs or history of neurological or psychiatric disease AND
* Written informed consent AND
* Participants are willing and able to comply with study procedures

Exclusion Criteria:

* RFC1: Missing informed consent
* Controls: evidence of neuropathy, neurodegenerative disease, or movement disorder; inability to give informed consent
Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes

Background : Type 1 diabetes (T1D) is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. As T1D is often diagnosed in childhood or early adulthood, the lower bone mineral density (BMD) and deteriorated bone microarchitecture observed in T1D may reflect changes in the bone that occurred before or at the time of peak bone mass achievement. There is a lack of high-quality prospective studies to determine whether adults with T1D continue to lose BMD or deteriorate bone quality compared with controls. Moreover, while chronic hyperglycemia is a risk factor for fracture in T1D, it is unknown if better glycemic control affects bone outcomes.

This prospective multicenter cohort study aims: (1) To compare the changes in the following outcomes over 4 years in adults with T1D and controls without diabetes of similar age, sex and body-mass index distribution: BMD by dual-energy X-ray absorptiometry (DXA) at the femoral neck, hip, spine, and radius, trabecular bone score (TBS) by DXA, and serum biochemical markers of bone turnover (BTMs); (2) To evaluate whether long-term glycemic control or the presence of a microvascular complication are independent predictors of the changes in BMD and TBS in people with T1D.


Eligibility Criteria:
Individuals with type 1 diabetes who have participated in the DenSiFy (Diabetes Spine Fractures) study (NCT04064437)

Inclusion Criteria:

* Diagnosis of type 1 diabetes for at least 5 years;
* Age 20 years and older.

Exclusion Criteria:

* Pregnancy, delivery or breastfeeding in the past 6 months;
* Conditions associated with bone disease (significant liver disease, intestinal malabsorption other than celiac disease, organ transplant, active cancer, rheumatoid arthritis, hyperthyroidism, hypothyroidism with abnormal TSH, hyperparathyroidism, hypoparathyroidism, hypogonadism, acromegaly, Cushing syndrome, adrenal insufficiency);
* Any of these medications since the first DenSiFy study visit : biphosphonates, teriparatide, denosumab, calcitonin, glucocorticoids ≥ 7,5 mg prednisone/day or equivalency ≥ 3 months, aromatase inhibitors, antiandrogens, antiepileptic drugs, anticoagulants, thiazolidinediones;
* Inability to consent.

Healthy controls who have participated in the DenSiFy (Diabetes Spine Fractures) study (NCT04064437)

Inclusion Criteria:

* Age 20 years and older.

Exclusion Criteria :

* As above (as individuals with diabetes), and :
* Diagnosis of diabetes or prediabetes;
* Celiac disease;
* Chronic kidney disease (CrCl \< 60 mL/min).
Effect of Kangaroo Care on Test Weighing

The study will be conducted with the Crossover Randomized Controlled Method. The infants who have attained oral feeding in the neonatal intensive care unit will be divided into two groups via randomization in the computer environment. After the randomization, kangaroo care will be applied to the infants in Group 1 during the first feeding hour when they are included in the study and they will be breastfed by their mothers without any other application during the next feeding. On the other hand, no application will be performed on the infants in Group 2 during the first feeding hour when they are included in the study and kangaroo care will be applied to them during the second feeding hour. The infants in both groups will be breastfed by their mothers during the feeding hours.

Test weighing is a feeding evaluation method which is used for evaluating the increase in infant's body weight and the amount of food intake before and after breastfeeding. Each gram is evaluated to be equivalent to one cc breast milk. The aim of the study is to evaluate the effect of kangaroo care applied to the preterm infants that have attained oral feeding and are breastfed by their mothers, on their physiological parameters, feeding condition and body weight increase. After weighing the infant only in his/her diaper before the feeding and applying kangaroo care in which skin-to-skin contact will be provided for half an hour, the mother will breastfeed the infant. The infant will be weighed once again after the feeding without diaper change and the effect of kangaroo care on test weighing and physiological parameters during the feeding process will be evaluated. Sample size of the study has been determined by the power analysis, in line with the results obtained from the studies which have been conducted using a similar research method. According to the analysis results, it has been calculated as 23 for each group and 46 in total. Parents of the infants meeting the study inclusion criteria will be informed both in written and verbally and then the study will be conducted with mothers who agree to participate in the study with their infants.

Eligibility Criteria:
Inclusion Criteria:

- Agreeing to participate in the study for parents.

The inclusion criteria for infants were as follows;

* Attaining to oral feeding by the physician in the neonatal intensive care unit
* Being born at 26-36+6 gestational week which is determined according to the mother's last period cycle
* Being at 32-39+6 postmenstrual week during the time they are included in the study
* Having body weight of 1500 grams and above
* Being breastfed at least once
* Having no health problems other than being preterm

Exclusion Criteria:

The exclusion criteria for infants were as follows;

* Suffering from gastrointestinal, neurological or genetic diseases (such as necrotizing enterocolitis, intracranial bleeding, hydrocephalia, omphalocele, down syndrome, gastroschisis) and other diseases
* Having a condition obstructing oral feeding (such as cleft palate, cleft lip, facial muscle paralysis, craniofacial abnormalities etc.)
* Receiving oxygen support
The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma

This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* FIGO stage: Ⅰ, endometrial carcinoma;
* Female, Chinese women;
* Initial treatment is staging surgery;
* Pathological diagnosis: Endometrial adenocarcinoma;
* Pathologic examination and meet the following one of the indications of adjuvant therapy: ① histopathological grading in poorly differentiated: G3; ② ≥50% myometrial invasion; ③ vascular space involvement;
* No prior treatment;
* Provide written informed consent.

Exclusion Criteria:

* Unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;
* Family history of ovarian cancer;
* Suffering from other malignancies;
* Concurrently participating in other clinical trials;
* Unable or unwilling to sign informed consents;
* Unable or unwilling to abide by protocol.
The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota

The effect of portal hypertension on gastrointestinal motility, and how reversal or improvement in portal hypertension may alter gastrointestinal motility, remains unclear and further research is needed. Additionally, patients with cirrhosis have altered gut microflora, particularly rich in lactobacilli, including enterococci and bifidobacteria. Transjugular Intraheptic Portosystemic Shunting (TIPS) is a procedure performed by interventional radiologists, in which a connection is made between the portal and venous circulations, allowing high pressure portal blood to more easily enter the systemic circulation and bypass the liver; thus effectively decreased portal pressure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with either radiographic or biopsy proven decompensated cirrhosis (as determined by ascites, variceal hemorrhage, encephalopathy or jaundice).
* Patients undergoing an elective TIPS for any standard of care established indication (examples: worsening ascites, recurrent variceal bleeding).

Exclusion Criteria:

* Pregnant women.
* Patients unwilling or unable to provide informed consent.
* Patients undergoing an emergent TIPS for acute or subacute variceal hemorrhage.
* Patients with diabetes, significant cardiovascular, renal or other chronic disease which has been known to affect intestinal motility.
* Previously diagnosed gastroparesis or other GI dysmotility disorder.
* Patients currently taking narcotics, antibiotics excluding rifaximin, prokinetic medications or lactulose.
* Patients with a history of gastric bezoar.
* Patients with a history of multiple intestinal surgeries or GI surgery within the past 3 months.
* Patients with a history of gastrointestinal strictures, fistulas, or physiological or mechanical obstruction.
* Patients with a history of gastrointestinal strictures, fistulas, or physiological or mechanical obstruction.
* Patients with a history of gastrointestinal strictures, fistulas, or physiological or mechanical obstruction.
* Patients with a history of diverticulitis.
* Patients with swallowing disorders and increased risk of aspiration (such as prior history of aspiration).
* Patient with Celiac disease.
* Patients with implanted or portable electro-mechanical medical devices.
Questionnaire of the Section Perioperative Intensive Care of the European Society of Intensive Care Medicine (ESICM) on Standardized Drug Labelling

Medication errors are common in intensive care (Valentin A et al., BMJ. 2009;338). Standardized color coded labels for user applied syringes enjoy strong support from many health professionals, thinking that this might increase patient safety. Whether this is true or not warrants further research.


Eligibility Criteria:
Inclusion Criteria:

Members of the European Society of Intensive Care Medicine (ESICM)
Study of TAK-816 in Healthy Infants

The purpose of this study is to evaluate the efficacy (immunogenicity) of TAK-816 when administered to healthy Japanese infants as multiple subcutaneous doses.

Haemophilus Influenzae type b (Hib) is one of the major causes of infectious meningitis in children, and can also cause sepsis, cellulitis, arthritis, epiglottitis, pneumonia and myelitis.

TAK-816 is a conjugated Hib vaccine being tested in healthy infants aged 3-6 months at the time of the first dose.

The objective of this study is to evaluate the efficacy (immunogenicity) and safety of TAK-816 (10 ϻg/0.5 mL) in comparison with ActHIB (Haemophilus b Conjugate Vaccine) as a control.

In addition, the efficacy (immunogenicity) and safety of Absorbed Diphtheria-Purified Pertussis-Tetanus Combined (DPT-TAKEDA) vaccine when TAK-816 and DPT vaccine are administered concomitantly will also be investigated.

For the Primary Immunization Phase of this study: three doses of TAK-816 or ActHIB 10 µg/0.5 mL and DPT-TAKEDA 0.5 mL will be administered at 4-week intervals over 8 weeks (Visit 1, 2, 3). At4 weeks after the third dose, a follow-up observation and evaluation will be made (Visit 4).

For the Booster Vaccination Phase of this study: a single dose of TAK-816 or ActHIB 10 µg/0.5 mL and DPT-TAKEDA 0.5 mL will be given at 52 weeks after the third dose (Visit 5). At 4 weeks after the fourth dose, a follow-up observation and evaluation will be made (Visit 6).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female infants aged ≥3 and \<7 months (excluding hospitalized infants).
2. Infants whose legal acceptable representatives have given informed consent to the study prior to enrollment.
3. Infants whose parents or legal guardians have agreed to cooperate with the investigator during the study period.

Exclusion Criteria:

1. Any serious acute illness.
2. Any underlying cardiovascular, renal, hepatic, or hematologic disease, and/or developmental disorder.
3. History of possible Haemophilus influenzae type b (Hib) infection.
4. History of possible pertussis, diphtheria or tetanus infection.
5. Previously diagnosed immunodeficiency.
6. A documented history of anaphylaxis to any ingredient of the investigational products (TAK-816, ActHIB or DPT-TAKEDA).
7. A history of convulsions.
8. Previous administration of another Hib vaccine.
9. Previous administration of any other vaccine containing any of the components of polio, diphtheria, pertussis, or tetanus.
10. Treatment with any live vaccine during the 27 days before the first dose of TAK-816 or with any inactivated vaccine during the 6 days before dosing.
Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors

RATIONALE: A breast cancer rehabilitation program and exercise therapy may help improve the quality of life of breast cancer survivors.

PURPOSE: This clinical trial studies a breast cancer rehabilitation program in improving quality of life in breast cancer survivors.

PRIMARY OBJECTIVES:

I. To estimate accrual, retention, adherence, and participation of breast cancer survivors to a breast cancer rehabilitation program.

II. To estimate the variability of weight, six-minute walk, quality of life and other psychosocial and physical measures in women participating in the BCRP.

SECONDARY OBJECTIVES:

I. To assess changes in the anthropometric, psychosocial, and physical outcomes over the six-month period of the BCRP.

II. To document the types and the rates of adverse events associated with the BCRP.

OUTLINE:

Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise.

Eligibility Criteria:
Inclusion

* First occurrence of breast cancer
* BMI \>= 25
* Recently completed treatment(chemotherapy/radiation) for breast cancer (=\< 8 weeks), but can be receiving adjuvant hormonal therapy
* Willing to comply with study visits, as outlined in the protocol
* Lives within 30 miles of study site, or willing to travel to study site if outside a 30-mile radius
* Ability to participate in a moderate exercise program, such as freedom from any orthopedic abnormalities that would prevent participation
* Ability to understand and the willingness to sign a written informed consent document

Exclusion

* Unstable angina
* Cardiac conduction disturbances
* Plans to move from the study area
* Dementia that is medically documented or suspected
* Advanced arterial disease causing ischemia of any limb
* Physical immobility
* Homebound for medical reasons
* Dependent on wheelchair for mobility
* Chronic disease which significantly reduces 4-year survival
* Recurrent breast cancer
The Effect of Diaper Change Position on Preterm Infants

The purpose of this study is to determine the effect of diaper change position on neonatal comfort and heart rate, respiratory rate and oxygen saturation in preterm infants.

This study was planned as a randomized controlled prospective trial until reaching the entire sample group specified in the Neonatal Intensive Care Units (NICU) in a private hospital that has other branches in Istanbul.

During the data collection process, two methods will be applied to preterm infants during diaper change.

In the control group of the study, diaper change will be performed after the legs of the babies are brought to extension, and in the experimental group, the diaper change will be performed after the legs of the babies are brought closer to the abdomen by maintaining their flexion. Data on the babies' heart rate, respiratory rate, oxygen saturation and comfort level will be collected using the Premature Infant Comfort Scale before, during, immediately after and 3 minutes after the procedure.

The researchers will collect the data by using a form that questions individual characteristics and includes records of heart rate, respiratory rate and oxygen saturation and Premature Infant Comfort.

Eligibility Criteria:
Inclusion Criteria:

* The preterm infants whose
* Parents have agreed to participate in the study and have signed the informed consent form,
* Who have no congenital anomalies,
* Have no chronic illnesses,
* Have undergone Underwent no surgical procedures,
* Have no neurological symptoms,
* Have not been diagnosed with sepsis,
* Have not been sedated,
* Have not received any pharmacological analgesic method four hours before,
* Have been born between ≥28 and ≤36+6 gestational weeks or have been born earlier and are between ≥28 and ≤36+6 gestational weeks during the application, will be included.

Exclusion Criteria:

The preterm infants whose

* Parents have not agreed to participate in the study and have not signed the informed consent form,
* Who have congenital anomalies,
* Have chronic illnesses,
* Have undergone surgical procedures,
* Have neurological symptoms,
* Have been diagnosed with sepsis,
* Have been sedated,
* Have received pharmacological analgesic methods four hours before,
* Were between \<28 and \>36+6 gestational weeks, will be excluded.
Impact of Chromium, Phyllanthus Emblica, and Shilajit on Cardiovascular Health, Fitness, and Weight Loss During Exercise and Diet Programs

A randomized, double-blind, placebo controlled, parallel study to determine if Chromium (Cr), Phyllanthus emblica (PE) and Shilajit (SJ) supplementation and Phyllanthus emblica fruit extract supplementation promotes greater changes in glucose homeostasis, endothelial function, and cardiometabolic risk in sedentary and overweight men and women initiating an exercise and weight loss program.

Men and women with at least 2 markers of metabolic syndrome will participate in a randomized, placebo-controlled, parallel, and repeated measures intervention trial. Volunteers will participate in a standardized resistance training (3 sessions/week) and aerobic training (3 x 30 min sessions/week) program while reducing energy intake by 5 kcals/kg/d.

In a double-blind and randomized manner, participants will be matched by age, sex, BMI, and body mass to supplement their diet with placebo (PLA), 400 mcg of trivalent chromium with 6 mg of PE and 6 mg of SJ (Cr-400), or 800 mcg of trivalent chromium with 12 mg of PE and 12 mg of SJ (Cr-800), or 500 mg of PE (PE-500), or 1000 mg of PE (PE-1000) once a day after breakfast for 12-weeks.

Fasting blood samples, DEXA body composition, platelet aggregation, and ultrasound flow-mediated dilation (FMD) studies will be conducted at 0, 6, and 12 weeks of supplementation.

Eligibility Criteria:
Inclusion Criteria:

1. Sedentary males and females age 30-65 years with a BMI \>30 and/or percent body fat \>30%
2. Medical clearance for participating in moderate to intense exercise training and testing;
3. meet the 2006 International Diabetes Federation criteria for central obesity (ethnicity specific waist circumference) and any two risk factors to metabolic syndrome (i.e., fasting triglycerides \> 150 mg/dL or treatment for high triglycerides, HDL \<40 mg/dL in males and \<50 mg/dL in female, resting SBP \>130 mmHg or DBP \>85 mmHg or treatment of previously diagnosed hypertension, blood glucose ≥ 100 mg/dl or previous diagnosis for Type II diabetes);
4. Absence of limiting musculoskeletal injury that would prevent participation in a general fitness program; and,
5. Has given voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

Participants will not be allowed to participate in the study if:

1. they currently take or have taken nitrous oxide or anti-inflammatory type supplements or medications within one month of the start of the study;
2. they have uncontrolled hypertension, triglycerides \>500 mg/dL, elevated AST and ALT \> 3 times the upper limit, and serum creatinine \>1.5 mg/dL);
3. They do not receive medical clearance from their personal physician to participate in the study and exercise program;
4. They are pregnant or plan to become pregnant; and/or
5. They are unable to complete at least 90% of the training.