louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03228862: Optimal Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Adults
Official title: Optimal Initial and Maintenance Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Thai Adults: A Randomized, Double-blinded Dose-comparison Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vitamin D2 Supplementation in Vitamin D Insufficiency
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 360
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the optimal initial and maintenance doses of vitamin D2 supplementation for the treatment of vitamin D insufficiency in Thai adults, and to determine the prevalence of and risk factors for hypovitaminosis D among Thai adults.

Detailed description: A double-blinded prospective, randomized study undertaken at outpatient clinic of King Chulalongkorn Memorial Hospital. The patients with vitamin D insufficiency were included and divided into three groups according to their initial 25OHD concentrations. Patients are randomly assigned to receive vitamin D2 40000, 60000 or 80000 IU once weekly. Serum 25(OH)D levels are measured at 12 weeks after vitamin D2 supplemetaiton. The patients with 25OHD more than 30ng/mL are enroll into the maintenance phase of the study and are randomly assigned to receive vitamin D2 20000 or 40000 IU once weekly for another 12 months. The 25OHD concentration are measure again at the end of the study.

Eligibility criteria: Inclusion Criteria:

1. Adult age ≥ 15 years
2. BMI 18 - 35 kg/m2
3. Serum 25(OH)D \< 30ng/ml

Exclusion Criteria:

1. Hypercalcemia, nephrolithiasis, or fractures
2. Hepatic disease
3. Kidney disease
4. Granulomatous disease
5. Currently supplemented with vitamin D

Primary outcomes:
measure: serum 25OHD phase 1
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn Univerity and King Chulalongkorn Memorial Hospital
Study officials:
References:
Clinical trial NCT04513262: Effects of Video-Assisted Surgery on Ventilatory Parameters
Official title: Effects of Pneumoperitoneum on Ventilatory Parameters in Patients Undergoing Video-assisted Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery--Complications
Lead sponsor: Institutul Clinic Fundeni
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients undergoing video-assisted surgery in a university hospital after inclusion and exclusion criteria have been met. Video-assisted surgery is defined by either classic laparoscopic surgery or robotic assisted surgery and the medical decision between the two types of surgery was performed by the attending surgeon prior to patient inclusion (unrelated to the study).

Brief summary: The study investigates the effects of induced pneumoperitoneum during surgery on ventilatory parameters including peak inspiratory pressure, lung compliance, end-tidal CO2 at specific time-points: after induction of anaesthesia, after induction of surgery, one-hour and two-hours during surgery, end of surgery.

The effects of pneumoperitoneum are compared between two groups of patients: patients undergoing laparoscopic surgery and patients undergoing robotic-assisted surgery. No intervention was performed in this study and the decision for type of surgery performed was made by the attending surgeon prior to study inclusion


Eligibility criteria: Inclusion Criteria:

* patients who underwent video-assisted surgery by either classic laparoscopy or robotic-assisted surgery.

Exclusion Criteria:

* refusal to participate
* conversion of surgery to laparotomy
* need of vasopressure support
* preoperative severe respiratory dysfunction

Primary outcomes:
measure: lung compliance
timeFrame: one-hour and two-hours after induction of pneumoperitoneum
Secondary outcomes:
measure: arterial to end-tidal CO2 difference
timeFrame: one-hour and two-hours after induction of pneumoperitoneum
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
Study officials:
affiliation: Fundeni Clinical Institute
name: Dana Tomescu, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT04274062: Effects of Peri Partum Integrated Nursing Care Versus Routine Care in Placenta Previa : A Randomized Controlled Trail
Official title: Effects of Peri Partum Integrated Nursing Care Versus Routine Care in Placenta Previa : A Randomized Controlled Trail
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Previa Total
Nursing Role
Keywords: placenta previa
Nursing
antepartum hemorrhage
randomized trial
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant Placenta previa

Brief summary: At our institution, the annual number of placenta previa was 494 cases (1.7%); of whom 95 cases (19.2%) were proved to have a placenta accreta. Perioperatively, they are subjected to regular care of a tertiary university hospital. This study aims to determine the effectiveness of peri partum integrated nursing care for the patients with placenta previa versus routine care.

Detailed description: Study design:

Experimental design: (randomized control trail)

Setting:

This study will be conducted at Woman's Health Hospital, Assiut University, emergency department and inpatient department.

Sample:

A convenience sample will be used, the total sample will include (100) patients with placenta previa, divided into two group1:1

* group 1: 50 patients study group
* group2: 50 patients control group

Eligibility criteria: Inclusion Criteria:

* Pregnant women with diagnosis of placenta previa.

Exclusion Criteria:

* Other high risk pregnancy cases

Primary outcomes:
measure: Improved maternal and fetal well beings in cases of placenta previa
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Woman's Health University Hospital
Study officials:
affiliation: Woman's Health University Hospital
name: Atef Darwish
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01013662: Lipid Profile in Patients With Severe Sepsis or Septic Shock Under Strict or Liberal Glycemic Control
Official title: Tight Glycemic Control and Sepsis Related Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Sepsis
Keywords: septic shock
glycemic control
icu
lipid metabolism
septic patients
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-11-16
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Study of the lipid metabolism under glycemic control in septic patients who got an university 14 bed ICU.

Hypothesis: establish a relationship between lipid metabolism alterations and glycemic control or infusion of exogenous insulin

Detailed description: The investigators enrolled 69 consecutive patients with severe sepsis or septic shock and divided them in two different groups after randomization with sealed envelopes.

One group called intensive glycemic control with glycemic levels been between 80 to 110 mg/dl with exogenous insulin.

The other group called conventional glycemic control with glycemic levels been between 180 and 220 mg/dl.

Blood samples were collected at 0, 12, 24, 48 and 72 hours to measure HDL, LDL, Total cholesterol, free fatty acids and oxidized LDL.

Clinical data as creatinine, P/F ratio, bilirubins, platelets, lactate, arterial blood gasometry were either monitored.

Eligibility criteria: Inclusion Criteria:

* all patients aged between 18 and 80 years old
* with the diagnostic of septic shock or severe sepsis

Exclusion Criteria:

* pregnants,
* previous diagnosis of any cancer,
* diagnosis of leptospirosis,
* diagnosis of aids.

Primary outcomes:
measure: establish a relationship between lipid metabolism alterations and glycemic control
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cappi SB, Noritomi DT, Velasco IT, Curi R, Loureiro TC, Soriano FG. Dyslipidemia: a prospective controlled randomized trial of intensive glycemic control in sepsis. Intensive Care Med. 2012 Apr;38(4):634-41. doi: 10.1007/s00134-011-2458-z. Epub 2012 Feb 2.
Clinical trial NCT03252262: Power V360 - Promoting Optimal Wellness Among Elders Through Vitalize 360
Official title: Power V360 - Promoting Optimal Wellness Among Elders Through Vitalize 360
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health, Subjective
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 161
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary purpose of this project was to implement Vitalize 360, a comprehensive assessment system and wellness coaching program for vulnerable, low income, community dwelling older adults, and to determine if this program is effective in promoting and sustaining self-management skills to increase well-being and functional health among this group. Designed specifically for community-dwelling older adults, Vitalize 360 provides a unique opportunity to guide elders in selecting personal goals that align with their assessment results and develop an action plan for goal achievement. This strategy holds potential as an effective mechanism to empower elders to implement behaviors that promote healthy aging.

Detailed description: The purpose of this project was to determine if Vitalize 360, a comprehensive assessment system and wellness coaching program was effective in promoting and sustaining increased physical activity and improved mood, health status and quality of life. A repeated measures, secondary analysis design was the selected approach Data from 161 participants were used to test the hypotheses. After one year, the sample had improvement with increased socialization while physical activity level fluctuated over time suggestive of a seasonality effect. Paired t-tests and repeated measures analysis revealed no statistically significant improvement in physical activity level, mood, health status or quality of life. Vitalize 360 provides a unique opportunity to guide elders in selecting personal goals that align with their assessment results and develop an action plan for goal achievement. When used among vulnerable and frail elders, some modifications are needed to provide sustained, favorable outcomes.

Eligibility criteria: Inclusion Criteria:

Age 60 years and over, residing in subsidized housing sites operated by Hebrew SeniorLife and participating in Vitalize 360 program

Exclusion Criteria:

younger than 60 years, not participating in Vitalize 360 program and not a permanent resident of housing sites.

Primary outcomes:
measure: Physical Activity Level
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hebrew Rehabilitation Center
name: Elizabeth P Howard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06577662: Effects of the Individual and Family Self-Management of Fall Prevention Program on Balance Ability and Fall Efficacy Among Chinese With Post-Stroke
Official title: Effects of the Individual and Family Self-Management of Fall Prevention Program on Balance Ability and Fall Efficacy Among Chinese With Post-Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-stroke People
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is about exploring the effectiveness of individual and family self-management (IFSM) fall prevention programs on balance ability and fall efficacy in post-stroke people. The main intervention measures were developed based on the risk and protective factors of fall prevention in post-stroke people, including exercise, environment safety, assistant technology, medication review, and safety in daily activities. The intervention will be implemented in 10 weeks for both patients and their family members. By mastering these skills, post-stroke people may reduce the number of falls after discharge to home.


Eligibility criteria: Inclusion Criteria:

* For patients (a) aged 18 years or above; (b) first-ever diagnosed with ischemic stroke; (c) level of impairment assessed by the National Institutes of Health Stroke Scale (NIHSS) scores between 5 to 15 (moderate severity) before entering the experiment; (d) mental state assessed by Mini-Mental State Exam score\&gt; 24; (e) mobility tested by Timed Up and Go ≥12.6 second (walkers or another kinds of gait aid are allowed to be used in the test); (f) motor power of all limbs examined by muscle power assessment grade ≥3; (g) ability to understand Chinese; (h) living with family members; (i) having phones that can use the internet; (j) willing to join the study.

For caregivers: (a) mental state assessed by a Short Portable Mental Status Questionnaire score≥8; (b) the primary caregiver who lives in the same house and takes care of the patients; (c) having phones that can use the internet; (d) willing to participate; and (e) can speak, understand, and write in Chinese

Exclusion Criteria:

* having problems with sensory and/or global aphasia

Primary outcomes:
measure: Fall efficacy
timeFrame: Fall efficacy will be measured before the fall prevention program and after patients are discharged in 8 weeks.
measure: Balance ability
timeFrame: Balance ability will be measured before the fall prevention program and after patients are discharged in 8 weeks.
Secondary outcomes:
measure: Number of falls
timeFrame: Number of falls will be measured after patients are discharged in 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04986462: Arthroscopic Treatment of Bursal-side Rotator Cuff Tears in Shoulder Joint
Official title: Arthroscopic Treatment of Bursal-side Partial-thickness Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tears
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with bursal-side partial-thickness rotator cuff tears, there has been very little research on bursal-side partial-thickness rotator cuff tears, which has no consensus on diagnosis and treatment.

Brief summary: A retrospective analysis was performed on patients with bursal-side partial-thickness rotator cuff tears who underwent arthroscopic surgery from January 2009 to December 2011. To investigate the diagnosis and arthroscopic treatment of partial rotator cuff bursa lateral tear, and to evaluate the postoperative functional outcome and tendon healing.

Detailed description: To study the surgical method and clinical effect of arthroscopic treatment for partial tear of rotator cuff bursa. A retrospective analysis was performed on patients bursal-side partial-thickness rotator cuff tears who underwent arthroscopic surgery from January 2009 to December 2011. Preoperative X-ray and MRI were performed. Rotator cuff repair was performed during the operation. UCLA shoulder scoring scale was used to evaluate the joint at preoperative and final follow-up.

Eligibility criteria: Inclusion Criteria:

* From January 2009 to December 2011, patients with bursal-side partial-thickness rotator cuff tears who underwent arthroscopic surgery at Peking University Third Hospital and were followed up.

exclude:

Exclusion Criteria:

* Patients with frozen shoulder and unstable shoulder joints.

Primary outcomes:
measure: UCLA (University of California, Los Angeles) Shoulder Score Scale at 1 year after operation.
timeFrame: 1 year after operation
measure: UCLA (University of California, Los Angeles) Shoulder Score Scale at 2 years after operation.
timeFrame: 2 years after operation
measure: UCLA (University of California, Los Angeles) Shoulder Score Scale at 5 years after operation.
timeFrame: 5 years after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: jian xiao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01007162: Patient Satisfaction in the Critical Care Unit: A Qualitative Phenomenological Study
Official title: Patient Satisfaction in the Critical Care Unit: A Qualitative Phenomenological Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Satisfaction in the Critical Care Unit
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-11-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients who were admitted to the Critical Care Unit at the Royal Marsden Hospital

Brief summary: To explore issues patient experience and satisfaction with a sample of patients recently discharged from critical care.

Detailed description: Patients' perceptions of their medical care are of increasing importance to educators, researchers, and clinicians. The emphasis on patient experience and satisfaction is consistent with the trend towards holding health care professionals accountable to their consumers. Our understanding and advancement of patients' experience and satisfaction with care forms a pivotal role in ensuring individuals engage with healthcare services, adhere to therapies, and maintain ongoing relationships with providers. Experiences are best explored using interview techniques such as phenomenological interviewing. In our study we propose to use a hermeneutic phenomenological approach. Phenomenology is a way of qualitatively exploring a person's experience and their personal meanings from those experiences. It is an approach that considers the structure of a person's subjective experience and explores areas that might be hidden. A phenomenological approach looks for patterns that are shared by particular instances or experiences. The evaluation of patient satisfaction and experience is based on valuing patients' subjective perception of an experience. In our study, a phenomenological approach will generate a comprehensive description of a phenomenon or lived experience (i.e. stay in the Critical Care Unit). We will interview a sample of patients to explore experiences and to gain their meanings of their stay in critical care. This will hopefully lead to thinking around ways of improving patient experiences, satisfaction and care.

Eligibility criteria: Inclusion Criteria:

* Cancer patients who were admitted to the Critical Care Unit at the Royal Marsden Hospital
* Patients who are not now at the End of Life or palliative.
* Adults (i.e. patients \>18 years of age.
* Patients staying more than 24 hours.

Exclusion Criteria:

* Very short stay patients (\<24 hours)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Natalie Pattison
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06279962: Survey Experiment to Estimate Level of Mental Illness Stigma Based on Condition and Gender
Official title: Measuring Level of Mental Illness Stigma Based on Condition and Gender
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Stigma, Social
Keywords: stigma
mental illness
low-income country
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Empower Through Health
First posted: 2024-02-28
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness.

Detailed description: This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness. This study utilizes eight vignettes portraying different mental illnesses and genders to measure the levels of mental illness stigma in the general community in rural Uganda.

Eligibility criteria: Inclusion Criteria:

* All adults who consider Buyende District their primary residence and who are capable of providing consent

Exclusion Criteria:

* Minors younger than 18 years of age
* Persons who do not consider Buyende District their primary place of residence

Primary outcomes:
measure: Level of acceptance for the individual depicted in the vignette as measured by PERSONAL ACCEPTANCE SCALE
timeFrame: Study period. For each interview, approximately 60 minutes.
measure: Level of acceptance for the individual depicted in the vignette as measured by BROAD ACCEPTANCE SCALE
timeFrame: Study period. For each interview, approximately 60 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Iganga
country: Uganda
facility: Empowerment to Heal - Uganda
Study officials:
References: