cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Vitamin D Requirements During Pregnancy

The purpose of this study is to determine the effectiveness of vitamin D supplementation during pregnancy starting at the beginning of the second trimester. Mothers will be randomized to one of three vitamin D dosing groups: 400, 2,000 or 4,000 international units per day. It is hypothesized that the highest dosing regimen will result in a better vitamin D status of women regardless of their ethnicity or race.

The prevalence of hypovitaminosis D in reproductive aged African-American women occurs at a rate of \> 40%. Two factors have contributed to this public health problem: an inadequate DRI for vitamin D and avoidance of sun exposure/use of sunscreen. This startling rate of hypovitaminosis D requires that the DRI for vitamin D in pregnancy be evaluated in a detailed manner. The Cochrane Library (2002) released a report stating that there is insufficient data to evaluate the effects of vitamin D supplementation during pregnancy. Recently, the safety of prolonged supplementation with up to 25x's DRI (10,000 IU/day) was demonstrated in nonpregnant adults. It is essential to determine what dose of vitamin D is required to eliminate hypovitaminosis D during pregnancy and provide the fetus/neonate with adequate vitamin D stores during development and growth, particularly in darkly pigmented individuals. The aim of this research proposal, then, is to determine the efficacy, effectiveness, and safety of maternal vitamin D supplementation (as a function of ethnicity and UV exposure) in the prevention of hypovitaminosis D in the pregnant mother and her fetus/neonate. We hypothesize that darkly pigmented mothers will require substantially higher oral supplementation with vitamin D to eliminate hypovitaminosis D as compared to their Caucasian counterparts. We propose a comprehensive clinical trial to test our hypothesis. Mothers at 12 weeks' gestation will be randomized to one of three vitamin D treatment groups:

1. Control, 400-,
2. 2,000-, or
3. 4,000 IU/day to be continued throughout pregnancy.

Calcium and vitamin D homeostasis and skeletal remodeling in the mother will be monitored closely throughout the pregnancy. Bone density of the mother will be measured at 12 weeks' gestation and one-month postpartum. Follow-up growth and skeletal integrity assessments of the infant will be performed at birth, 1, 6 and 12 months stratified by infant feeding regime. Through these proposed studies, the prevalence of hypovitaminosis D among mothers, their developing fetuses and neonates, and the utility of maternal therapeutic intervention with vitamin D for both mother and fetus/infant will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Women who are within the ages of 16-45 years
2. In good general health
3. Less than 12 weeks pregnant (based on last menstrual period)

Exclusion Criteria:

1. Mothers with preexisting type I or type II diabetes
2. Mothers with preexisting hypertension
3. Mothers with preexisting parathyroid disease or uncontrolled thyroid disease
4. Mothers with multiple fetuses (e.g., twins, triplets, etc.)
Let's Get Organized Feasibility Study

The aim of this study is to pilot test the Let's Get Organized (LGO) Occupational Therapy intervention in a Swedish context by exploring possible enhancements in time management skills, aspects of executive functioning, and satisfaction with daily occupations in persons with time-management difficulties due to neurodevelopmental and/or mental disorders.

Method:

A pre-post design with 3 and 12-months follow-up is used.

The LGO intervention is a manual-based group intervention aiming to enhance time-management, targeted to persons with mental or neurodevelopmental disorders. The LGO is conducted as 10 weekly 1.5-hour group sessions. Two trained group leaders, lead each group of 6-8 participants. Goal-directed and other learning strategies are used to train effective time management habits such as maintaining a calendar and wearing a watch. All group sessions follow the same format, and each session has a set theme. Group sessions are structured with a slide presentation and a course manual, and information from the group leaders is intermixed with discussion among the participants and tasks to complete.

The primary outcome of the study is self-reported time management measured by the Assessment of Time Management Skills (ATMS-S). Secondary outcomes are executive functioning measured with the Weekly Calendar Planning Activity (WCPA) and satisfaction with daily occupations, which is measured with the interview-administered questionnaire Satisfaction with Daily Occupations 13 items (SDO-13).

Data will be collected before intervention start (pre intervention), after intervention completion (post intervention) and 3 and 12 months post intervention completion. The ATMS will be collected at all four time points. The WCPA and SDO-13 will be collected pre, post and 12 months post intervention.


Eligibility Criteria:
Inclusion Criteria:

* confirmed or suspected diagnosis of a mental disorder, such as affective disorder or schizophrenia, or neurodevelopmental disorder, such as autism spectrum disorder or attention deficit hyperactivity disorder/attention deficit disorder
* self-reported difficulties in time management in daily life to an extent that affects functioning in daily life negatively

Exclusion Criteria:

* intellectual disability
Extracorporeal Carbon Dioxide Removal in Severe Chronic Obstructive Pulmonary Disease Exacerbation

The conventional treatment for Severe acute exacerbation of Chronic obstructive pulmonary disease including noninvasive respiratory support, invasive respiratory support, etc, but there are many kinds of limitations and complications. Extracorporeal Carbon Dioxide Removal is a life support technology, which can effectively remove CO2. Recently some clinical studies have showed that ECCO2R can effectively improve the AECOPD patient's respiratory failure, avoid intubation and removal of endotracheal intubation. We performed a study to evaluate the clinical effectiveness of ECCO2R in the treatment of AECOPD patients.

With the development of technology, ECCO2R is not difficult to implement in intensive care unit. Many recently clinical studies have showed that ECCO2R can effectively remove CO2, reduce patient breathing work, improve the patient respiratory failure, and avoid endotracheal intubation. But there are also treated failure and high incidence of complications such as bleeding in the AECOPD patients with ECCO2R treatment, and the treatment related to airway management are less mentioned. Therefore, we set a more strict inclusion criteria in AECOPD patients and evaluate the clinical effectiveness and associated risk of ECCO2R in the treatment of AECOPD.

Eligibility Criteria:
Inclusion Criteria:

* NPPV treatment failure:

  1. deterioration or no improvement after treatment with NPPV, pH \< 7.25, PaCO2 \> 70mmHg
  2. Obvious respiratory distress, RR \> 30 times/min
  3. Breathing extreme fatigue

Exclusion Criteria:

* Older than 75 years
* endotracheal intubation or tracheostomy
* obviously a lot of pus yellow phlegm, expectorate difficult
* Chest CT: obviously a wide range of consolidation
* BMI \< 20 kg/m2,
* Dysfunction of other organ of extrapulmonary
* serious hemodynamic instability
* severe hypoxemia, PaO2 / FiO2 \< 100mmHg
* home noninvasive positive pressure ventilation for a long time
* lung fungal infection
* contraindication of anticoagulation
* Platelet \< 80000 per cubic millimeter
* Serum creatinine \> 200 umol/L
* cardiac arrest
* Hospice care
* Refused to take part in the study
Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma

The purpose of this study is to assess the safety/tolerability/feasibility of pembrolizumab and radiation therapy before surgical resection in patients with recurrent glioblastoma as defined by treatment-related AEs and the number of patients who do not necessitate a delay in surgical resection, and to assess overall survival. The secondary objectives are to assess progression free survival, and to assess the T cell clonality, CD8 T cell activation and Tumor Infiltrating Lymphocyte (TIL) score after treatment


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Confirmed histologic diagnosis of WHO Grade IV, Glioblastoma Multiforme
* GBM recurrence or progression with planned standard of care surgical resection and repeat radiation
* Tumor size less than 6 cm
* ECOG performance status of 0-1
* Adequate laboratory values

Exclusion Criteria:

* Contraindication to additional radiation
* Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
* Immunodeficiency diagnosis or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone) or any other form of immunosuppressive therapy
* Severe hypersensitivity to pembrolizumab

Complete inclusion/exclusion criteria are detailed in the protocol.
Interpretation of Endoscopic Characteristics of Colorectal Polyps With Blue Light Imaging

Interpretation of endoscopic characteristics of colorectal polyps with Blue Light Imaging A study of BLI images and videos of colorectal polyps will be presented initially as a training set followed by with explanation and teaching in a didactic session to two separate groups. A post-test will be conducted to look at the quality of the learning experience.

To evaluate the teaching tool regarding the criteria for BLI images of colorectal polyps by the following measures

* Inter-observer agreement between same and different groups
* Accuracy in describing the morphology of colorectal polyps • This new teaching tool will improve
* Inter-observer agreement by at least 5%- 10% (depending on the group)
* Accuracy by at least 5%- 10% (depending on the group)• To determine the improvement of inter-observer agreement in identifying/ describing colorectal polyps after the didactic session in both the groups
* Overall Accuracy, Sensitivity, Specificity, Positive predictive value and negative predictive value pre-and post-test in both the groups


Eligibility Criteria:
Inclusion Criteria All gastroenterology attending physicians, gastroenterology fellows, residents and medical students at the VA medical center

Exclusion Criteria Not willing to participate H/O colour blindness or visual impairment Any intellectual disability
Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI

comparison of transvaginal ultrasound, transvaginal ultrasound elastography and MRI for the diagnosis of adenomyosis in patients receiving hysterectomy afterwards


Eligibility Criteria:
Inclusion Criteria:

* dysmenorrhea
* dyspareunia
* non cyclic lower abdominal pain
* hypermenorrhea
* menometrorrhaghia
* pain while compressing the Uterus during gyn exam
* Patient wants to participate
* Patient will receive hysterectomy

Exclusion Criteria:

* Patient declines to participate
* contraindications against MRI
* contraindications against ultrasound
* minor
* cannot give informed consent
* no hysterectomy planned
Chlorhexidine Disk for Prevention of Exit-site Infection in Peritoneal Dialysis Patients

The purpose of the study is to evaluate the efficacy and safety of chlorhexidine-impregnated disk in preventing catheter exit-site infection in peritoneal dialysis patients

The primary aim of the study is to examine the exit-site infection rate in patients using chlorhexidine-impregnated dressing.

The participant will be followed up at 2, 6, 12, 24, 36 and 52 weeks of study and during each visit the catheter exit-site will be examined by one of the investigators for any sign of infection or allergic reaction, and questionnaires about satisfaction with use of study material (biopatch) will be asked by a study team member at the 12 week visit of the study. Each participant will be followed up for one year.

Eligibility Criteria:
Inclusion Criteria:

* All adult incident peritoneal dialysis patients between 21 to 90 years old, who are followed up in Singapore General Hospital

Exclusion Criteria:

1. patients who have known history of allergy to chlorhexidine
2. patients who had previous history of peritoneal dialysis catheter exit-site infection
3. patients with mentally challenging conditions who are unable to give the valid consent for the study
4. patients who have been involved in another study for exit site infection
Seated Tai Chi Improves Dynamic Finger Pointing Task and Sitting Balance Control in Subjects With Parkinson's Disease

The goal of this prospective study is to investigate the effects of 3 months seated Tai Chi (TC) practice on the eye-hand coordination and sitting balance control of subjects with Parkinson's disease. The main objective it aims to answer are the effects of seated TC training on:

* Shoulder joint range of motion;
* Eye-hand coordination;
* Dynamic sitting balance control; and
* Quality of life in individuals with Parkinson's disease

Researchers compared seated TC training with a control group to see if it improved the aforementioned outcomes.

Participants completed:

* 3-month TC training of 24 sessions in total
* two sessions per week and each session lasted for 1-hour
* went on with their usual physical activities and routines outside the training


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Parkinson's disease (PD)
* Mini-Mental State Examination (MMSE) scored over 24
* Individuals with mobility levels suitable for participation in seated TC

Exclusion Criteria:

-
The PK Study of the JLP-1207 and Solifenacin/Tamsulosin in Healthy Male Volunteers.

The purpose of this study is to investigate and compare the pharmacokinetic characteristics and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in healthy male volunteers.

A randomized, open-label, single dose, two-way crossover study.

Eligibility Criteria:
Inclusion Criteria:

* 19\~45 years healthy male
* Body weight is over 55kg, BMI measurement 18.0kg/m\^2\~ 27.0kg/m\^2
* Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
* Researchers determined suitable volunteers through physical examination, laboratory tests

Exclusion Criteria:

* History of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
* Sitting SBP\>150mmHg or \<100mmHg, sitting DBP\>100mmHg or \<60mmHg, after 3 minutes break
* An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
* Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery)
* History of drug abuse
* Positive urine drug screening
* Administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study.
* Donated blood within 60 days prior to the first administration day in this study.
Effect of Medication Reviews Performed in High Risk Patients

The purpose of the study is to examine whether a stratified medication review performed in patients at highest risk of experiencing medication errors have impact on numbers of medication errrors during hospitalization.

Acutely admitted medical patients will be included after admission. After inclusion and randomization the patients will be risk stratified with an existing algorithm according to risk of medication error. The patients in the intervention group will receive a medication review performed by a clinical pharmacist if they are in high medication error risk. Patients in highest medication error risk will recieve a medication review performed by a clinical pharmacologist.

Eligibility Criteria:
Inclusion Criteria:

* Acutely admitted
* \>17 years
* Patients being treated with at least one drug at admission

Exclusion Criteria:

* Dying patients
* Suicidal patients
* Intoxicated patients
The Clinical Evaluation of Two Different Film Thicknesses of Clear Overlay Retainer.

The aims of this study were to compare health related quality of life, comforts degrees，retention effectiveness, and failure rates as well as survival times between two clear overlay retainers with different thicknesses, thus to provide basis information regarding appropriate selections of the thickness of clear overlay retainers.


Eligibility Criteria:
Inclusion Criteria:

* Patients after active orthodontic treatment;
* Must be healthy without systemic and oral diseases;
* The central incisors, canines and first molars of both upper and lower arches must be existed;
* Agreed to the trial and signed informed consent forms, either by themselves, or their parents.

Exclusion Criteria:

* Oral habits such as bruxism and clenching,
* Do not accept this type of retainers
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum

Our overall goal is to advance our understanding of the contribution of the carotid body chemoreceptors in glucose regulation and the development of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* healthy,
* type 2 diabetes
* BMI 18-40 kg/m2,
* non-pregnant,
* non-breastfeeding,
* non-nicotine users.

Exclusion Criteria:

* cardiovascular disease including myocardial infarction, heart failure, coronary artery disease, stroke;
* renal or hepatic diseases;
* active cancer;
* autoimmune diseases;
* immunosuppressant therapy;
* excessive alcohol consumption (\>14 drinks/week);
* current nicotine use;
* foot ulcers;
* diabetic neuropathy;
* medication directly influencing sympathetic nervous system activity
Predictive Role of Urodynamics on Mid-urethral Sling Failure

Purpose The aim of this study is to investigate the contribution of preoperative urodynamics to mid-urethral slings (MUS) success for developing an algorithm that uses conventional and easily accessible tools Methods Women with stress urinary incontinence and who desired surgical correction of their incontinence were included in the study. The selection of the procedure was according to an algorithm used in an institution developed by a chief of urogynecology department who had 25 years of urogynecology experience. Urodynamic and baseline factors that may be associated with surgery failure were analyzed in MUS failure.


Eligibility Criteria:
Inclusion Criteria:

* Documented pure or predominant SUI symptoms for at least 3 months, along with a positive standardized urinary stress test

Exclusion Criteria:

* prior incontinence surgery, post-void residual volumes of greater than 100 ml, a history of chronic inguinal or vulvar abscess, hidradenitis suppurativa, genitourinary fistula or urethral diverticulum, reversible cause of incontinence (i.e., drug effect), or any contraindication to surgery
Immunomodulation Effect of Regional Citrate Anticoagulation in Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

The purpose of this study is to study the effect of anticoagulation in immune response with Acute Kidney Injury (AKI) undergoing Continuous Renal Replacement Therapy (CRRT).


Eligibility Criteria:
Inclusion Criteria:

* Systemic inflammatory response syndrome; SIRS \> or = 2 meets definition
* Patients with acute kidney injury in the intensive care ward.
* Requiring continuous renal replacement therapy.

Exclusion Criteria:

* Pregnancy
* Cirrhosis
* End stage renal disease
* HIV infection
* Serum creatinine in male \> 2 mg/dl and female \> 1.5 mg/dl
* Bleeding
Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending multiple doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952.


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking male or female subjects (18-55 inclusive)
* Body mass index (BMI) of 19-35 kg/m2 (inclusive)
* For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception

Exclusion Criteria:

* History or presence of clinically significant disease
A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027)

This is a Phase I clinical trial including 2 parts to evaluate the safety and immune response to RotaTeq™ /placebo in subjects of 65 to 80 years of age. In Part I, approximately 60 subjects in US will be randomly assigned to 1 of 2 treatment groups receiving 3 doses of RotaTeq™ or placebo. In Part II, approximately 200 subjects internationally will be randomly assigned to 1 of 3 treatment groups. Part II will start after Part I data analysis is reviewed and approved by the FDA/CBER, the Safety Evaluation Committee (SEC) and other regulatory agencies. Duration for the entire study will be approximately 4 years.

Note: As the result of a business decision by the Sponsor, the study did not proceed with Part II. Therefore, this report includes the results for Part I only.


Eligibility Criteria:
Inclusion Criteria:

* Is 65 to 80 years of age with controlled chronic illness
* agrees to participate in the study by giving written informed consent and cognitively competent as assessed by Mini-Mental State Examination
* for Part I: subject is living independently outside any long-term care facilities; for Part II: subject is expected to be a resident in a long term care facility (LTCF) including nursing homes with the exception of hospice care
* can be adequately followed for safety via visit or phone
* subject's routine safety lab results are within specified ranges
* has negative test results for HIV, Hepatitis B, and Hepatitis C

Exclusion Criteria:

* abdominal cancer/surgery within the past 6 months
* known or suspected immune diseases, e.g. diabetes
* any chronic or relapsing infections
* a fever at the time of immunization
* active vomiting or diarrhea at the time of immunization
* chronic diarrhea, irritable bowel syndrome, or inflammatory disease of intestinal or colon in the past 12 months
* subjects' spouses/cohabitants are not healthy or are immunocompromised; roommates in LTCFs are not healthy and/or do not agree to participate in the study
* cannot be adequately followed for safety via visit or phone
* any other clinically significant conditions that, in the investigators' opinion, would interfere with subject's participation in the study