cyrilzakka/clinical-trials huggingface dataset:
Breakfast Meal Replacement

Purpose: To evaluate the effects of replacing breakfast with a high protein, high fat, high fiber meal replacement in overweight individuals, on body composition.

Participants: Healthy, overweight and obese individuals (ages 18-45 yrs) with no history of disease. Procedures (methods): In a randomized control intervention, subjects will complete 5 different testing sessions (pre-screening, 2 baseline testing sessions, and 2 post testing sessions) as well as an 8 week intervention period. Pre-screening will include written informed consent, health history questionnaire, nutrition analysis, and baseline anthropometric measures. Baseline testing will be split into two sessions and include measurements of resting metabolic rate (RMR), body composition, blood and saliva hormones, mood, satiety, and health related quality of life questionnaires, and a cardiorespiratory fitness assessment.

Subjects will be randomly assigned to treatment (8 week supplementation with meal replacement to be taken at breakfast) and control groups (continue normal eating habits) with 4 electronic correspondences throughout the supplementation period. All measures will be repeated in two post-testing sessions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, Overweight Men and Pre-Menopausal Women
* Participant agrees to maintain usual activity lifestyle
* Participant has a body mass index of ≥ 28 (men) and ≥25 (women) kg/m2 and/or %body fat of ≥ 25%
* Participant has provided written and dated informed consent to participate in the study
* Participant is willing and able to comply with the protocol
* Participant is apparently healthy and free from disease, as determined by a health history questionnaire (diabetes, heart disease, kidney disease, cancer, thyroid disorder, etc).
* Participant agrees to abstain from smoking, caffeine, tobacco, and alcohol before testing days
* Participant has stated a goal of losing weight or improving body composition

Exclusion Criteria:

* Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders (i.e. anything influencing exercise ability).
* Participant is using, or has used one of the following dietary supplements within 8 weeks prior to enrollment: Meal replacement shakes, Whey Protein, Beta-alanine, Creatine, beta-hydroxy beta methylbutyrate, Carnosine or Taurine
* Participant has lost or gained greater than ten pounds within the previous 3 months
* Participant is in, or has participated in another clinical trial within 4 weeks prior to enrollment
* Participant had or currently has a self-identified eating disorder
* Participant is pregnant or plans to become pregnant during the duration of the study
* Participant has a known allergy or sensitivity to any ingredient in the test product or placebo (determined from health history questionnaire)
Preventative Intervention for Cholera for 7 Days

The first objective of our study is to develop a theory-driven evidence-based targeted water, sanitation, and hygiene (WASH) intervention for household members of diarrhea patients in South Kivu, Democratic Republic of the Congo (DRC) through formative research and community engagement. The second objective is to conduct a randomized controlled trial of 2,320 household members of 580 severe diarrhea patients to evaluate the effectiveness of the developed targeted WASH intervention in terms of: 1. reducing diarrheal diseases household members of cholera and severe diarrhea patients; and 2. increasing WASH behaviors.

This study develops and evaluates a targeted water, sanitation, and hygiene (WASH) intervention to reduce cholera and severe diarrhea among the household members of diarrhea patients in South Kivu, Democratic Republic of the Congo (DRC) through formative research and a randomized controlled trial. This study will also investigate cholera and severe diarrhea transmission dynamics among diarrhea patient households using genomics and a risk factor analysis. The study will be divided into two phases: (1) the Formative Research and Intervention Development Phase; and (2) the Intervention Implementation and Evaluation Phase.

In the two arm randomized controlled trial of diarrhea patient households, we compare the standard message given in DRC to diarrhea patients to the PICHA7 mHealth program. The standard message arm is the standard recommendation given in DRC to diarrhea patients at discharge on the use of oral rehydration solution (ORS) for dehydration, and the importance of handwashing with soap and water treatment for disease prevention. The PICHA7 mHealth program arm will first be delivered during a health facility visit by a health promoter bedside to a diarrhea patient (adults and child) and their accompanying household members during the time of illness followed by two home visits during the 7-day high risk period for diarrheal disease transmission. The health promoter delivers a pictorial WASH module on how diarrhea can spread, and instructions on handwashing with soap, water treatment, and safe water storage. A diarrhea prevention package is provided containing: a one-month supply of chlorine tablets for water treatment, a soapy water bottle for handwashing, a handwashing station, and a water vessel with a lid and tap to ensure safe water storage. After health facility delivery of the program, patient households receive weekly voice and text messages from the PICHA7 mHealth program over 12 months on the recommended WASH behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Diarrhea patients presenting with three or more loose stools over a 24h period
* Having no running water inside of their home
* Plan to reside in Bukavu for the next 12 months
* Have a child \<5 years in their household
* Have a working mobile phone in the household

Exclusion Criteria:

* No one will be excluded because of age, sex, religion, or sexual preference
* Presenting at the health facility with a fever (COVID-19 prevention)
Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease

This study aims to describe hallucinations prevalence in a sample of patients affected by Parkinson's disease and consulting in an outpatient facility.

An unique one hour interview will be offered to volunteers patients. Patients participating to the study will be asked to answer a semi-structured questionnaire searching for hallucinations of all modalities, minor psychotic symptoms and delusions. Psychometric scales will be assessed to search for depressive symptoms, cognitive impairment and specific personality characteristics.

The study hypothesis is that hallucinations prevalence in Parkinson's disease is underestimated and is higher than usually described in the scientific literature when all hallucinations modalities and minor hallucinatory phenomenons are searched for.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years-old
* Absence of opposition from the patient himself/herself or his/her legal representant for his/her participation to the study
* Patient without superior age limit with a diagnosis of Parkinson's disease made according to the UKPDSBB criteria (UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria)
* Outpatient consulting in neurology at the Charpennes'hospital

Exclusion Criteria:

* Opposition to the study
* Deafness or blindness which could compromise the interview
Bone Mineral Density (BMD) in Cemented Versus Cementless Hip Resurfacing

The purpose of this study is to compare the bone mineral density of patients who have undergone either cemented or cementless hip resurfacing.

Recent research is inconclusive regarding the degree to which the density or strength of the bone around the hip implant is preserved following a hip resurfacing system. Certainly, there are many factors which contribute to the preservation of bone mineral density - we are studying the role of cement. More specifically, we are trying to compare outcomes between patients who receive the cementless Cormet Hip Resurfacing System to those who receive the cemented CONSERVE® Plus Total Resurfacing Hip System. Therefore, the primary purpose of the current study is to compare the bone mineral density between the cementless and cemented hip resurfacing systems. We are also comparing patients who receive these two different hip systems in terms of their x-rays and how they are managing with their hip.

Eligibility Criteria:
Inclusion Criteria:

* Must be undergoing primary hip surgery for Noninflammatory Degenerative Joint Disease
* must be skeletally mature, as determined by Risser sign or reaching 18 years of age
* Is reasonable expectation that patient will remain available for all FU's scheduled over course of 5 years

Exclusion Criteria:

* Previous fusions, acute femoral neck fractures, and above knee amputations
* evidence of active local infection
* neurologic or musculoskeletal disease that may adversely affect gait or weight bearing
* having previously undergone ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device
* BMI \>35
* neuropathic joints
* severe documented psychiatric disease
* patients requiring structural bone grafts
* documented allergy to cobalt chromium molybdenum
* ipsilateral girdlestone
* sickle cell disease
* significant femoral head or neck deformity, or significant acetabular wall deficiency
* patients with renal failure, defined as serum creatinine greater that 180 µmol/L
Compensatory and Restorative Rehabilitation Techniques in Stroke

The aim of this randomized controlled trial is to find the combined effects of restorative and compensatory cognitive rehabilitation techniques in mild cognitive impairment after stroke.

Stroke is a prevalent medical neurological condition that often results in cognitive impairments, particularly in the domain of executive functions. Cognitive impairment has a significant impact on executive function in stroke subjects. Cognitive impairment on the stroke survivor exist on any single domain such as attention, spatial ability, language and executive ability more frequently than the multiple domains.

Cognitive training has been shown to be beneficial for rehabilitation of patients with cognitive impairment, but the underlying mechanisms remain unclear.

The combination of restorative and compensatory rehabilitation techniques is beneficial for gaining control over cognitive rehabilitation techniques will improve executive functions. The retention effects evaluated additionally will add a broad insight in this regard. It will improve the learning power of brain through neural plasticity. This leads to restoration of everyday functioning. This study aims to investigate the effects of two distinct rehabilitation approaches on the executive functions of stroke survivors with MCI. Understanding how these rehabilitation strategies impact cognitive recovery is essential for individuals living with post-stroke cognitive impairments.

Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 70 years
* Both Genders
* Individuals diagnosed with stroke 6 months before enrollment
* Minimum 6 years of schooling
* Patients with mild cognitive impairment (score 18-25 on MOCA)
* Individuals able to maintain sitting and standing balance (score 41 on berg balance scale)

Exclusion Criteria:

* \>10 on post stroke depression rating scale (PSDRS)
* Spasticity (\>3 on Ashworth scale)
* Other psychological disorders
* Patients diagnosed with Alzheimer's and dementia
Trial of Cooling for Patients With Excel Cryo Cooling System in Intracerebral Hemorrhage (ICH)

The purpose of this study is to determine if cooling the neck of patients with ICH decreases brain temperature. In addition, the investigators will determine if the device improves the delivery of oxygen to the brain. A third goal is to determine if cooling the neck lowers intracranial pressure (which is often times high in patients after ICH).

This is a non-randomized device efficacy trial. Patients with \>20cc Supratentorial ICH and an invasive brain temperature monitor (either Licox or Temperature sensing intracranial pressure device) will be enrolled after consent. The Excel Cryo Cooling System collar will be placed around neck in up to 20 patients for two hours. The goal is to determine the effectiveness of this device in cooling the brain. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. During the study and for two hours after, the investigators will collect data concerning the brain temperature, body temperature, brain oxygen level and pressure both in the head and in the blood (blood pressure). The investigators will also collect demographic information about you (i.e. age, gender, medical risk factors) and information regarding your current disease process.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with brain injury in the Neurological ICU.
2. Consent from the patient or surrogate decision maker.
3. Warfarin induced intracerebral hemorrhages only after correction of INR to \<1.4.

Exclusion Criteria:

1. Cerebellar hemorrhages.
2. Moribund state where the physician team doesn't believe the patient will survive.
3. Patients who are being cared for with the intent of making them comfortable. DNR-CC (by Ohio law).
4. Known history of a blood dyscrasia such as CLL or essential thrombocytosis that could affect inflammation.
5. Known significant carotid artery stenosis (known \>50% stenosis by history or incidental hospital imaging). This will not be specifically tested. Patients found to have significant stenosis later in the hospital stay will have their data interpreted separately as well as in the total group.
5-Year Objective and Subjective Results of a Mid-Urethral Sling

Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align Urethral Support System.

Between June 2007 and December 2008, the investigators performed 155 Align mid-urethral slings in patients who were only receiving this operation. Very few studies have outcomes at 5 years of greater. The aim of this prospective cohort study is to evaluate five-year objective and subjective cure rates. Secondary endpoints will assess failure risk factors and describe any complications of the retropublic Align Urethral Support System five years postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* women
* complaint of stress urinary incontinence
* underwent Align urethral support system from June 2007-December 2008

Exclusion Criteria:

* concommitant procedures
Healthy Outcomes of Pregnancy Education

The purpose of this study is to determine if an integrated intervention addressing active smoking, environmental tobacco smoke exposure, depression and intimate partner violence, would improve pregnancy outcome among African American women.

This study recruited pregnant, English speaking women from the District of Columbia who were African American or Latina and had one or more of the following risk factors: active smoking, environmental tobacco smoke exposure, depression and intimate partner violence. Women were randomized to receive either an integrated intervention or usual prenatal care. Women randomized to the intervention arm received a cognitive behavioral intervention delivered during the prenatal period in four to eight sessions. Up to two postpartum booster sessions were provided. Sessions were delivered coincident with prenatal care visits. Careful attention was paid to individualizing counseling to provide an integrated approach to each participant's multiple risk factors. The outcomes of interest were primarily behavior change with regard to the risk factors and secondarily to improved birth outcomes, specifically birthweight and gestation.

Eligibility Criteria:
Inclusion Criteria:

* African American or Latina (by self report)
* At least 18 years of age
* English speaking
* Pregnant less than or equal to 28 weeks gestation
* Receiving prenatal care in the District of Columbia
* Had one or more of the following risk factors: active smoking, environmental tobacco smoke exposure, depression and intimate partner violence

Exclusion Criteria:

* Non-minority race (by self report)
* Younger than 18 years of age
* Non-English speaking
* Not pregnant or pregnant greater than 28 weeks gestation
* Receiving prenatal care outside the District of Columbia
* Responded negatively to questions about risk factors
* Suicidal ideation
Family-Based Prevention Program for Childhood Anxiety

This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children.

Anxiety disorders are serious conditions that can negatively impact a person's overall functioning. This study will enroll mothers with anxiety disorders and their children to determine whether a brief family-based intervention will reduce childhood anxiety better than standard care.

Participants will be randomly assigned to either the family-based prevention program or to evaluation only for 8 weeks. Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety. Self- and parent-reports, diagnostic interviews, a computerized memory task, and a videotaped parent-child interaction task will be used to assess participants. Assessments will be conducted at study start and one week after intervention completion (Week 9). Follow-up visits will be conducted at 6 and 12 months after intervention completion.

Eligibility Criteria:
Inclusion Criteria:

* Mothers with a current, primary anxiety disorder
* 7-12 year old children without an anxiety disorder

Exclusion Criteria:

* Mothers that do not have a current, primary anxiety disorder
* 7-12 year old children with an anxiety disorder
* 7-12 year old children that are currently receiving treatment for anxiety that could interfere with the study
Comparative Study of High Intensity Interval Training and Endurance Training in Juvenile Obesity

Exercise is an effective strategy to manage juvenile obesity; however this ideal exercise training mode is still unclear. In this study, the investigators compared the health-related effects of high intensity interval training versus endurance training in obese children.


Eligibility Criteria:
Inclusion Criteria:

* age between 8 and 12 years
* Body mass index (BMI) = 95th percentile, according to the First National Health and Nutrition Examination Survey
* no pharmacological treatment
* no evidence of metabolic, hormonal, orthopedic, and cardiovascular disease at the time of the study's commencement
* no participation in any regular exercise training program (except physical education classes, two days a week) at least 6 months before the commencement of the study and throughout the protocol.

Exclusion Criteria:

* non-obese participants
* physically active participants
* participants with cardiovascular diseases or any other condition that could preclude the participation in the the exercise training program
Phacotrabeculotomy Versus CCI+Phaco in Patients With Borderline Control of Intraocular Pressure

The purpose of the study is to determine whether combined cataract and glaucoma surgery (phacotrabeculotomy)is more effective in lowering intraocular pressure than cataract surgery alone in patients with borderline control of intraocular pressure.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Primary Open Angle or Pseudoexfoliative Glaucoma and Cataract

Exclusion Criteria:

* Other glaucoma than POAG or PEX-Glaucoma
* Medically uncontrolled Glaucoma:

IOP \> 24 mmHg with two topical medications IOP \> 21 mmHg with three topical medications

* IOP \< 18 mmHg with two topical medications IOP \< 16 mmHg with three topical medications
* previous ocular surgery
* other ocular pathologies affecting visual acuity
* disorders of immune system
Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Abdominal Myomectomy

the aim of the present study is to evaluate safety and efficacy of intravenous tranexamic acid versus vaginal dinoprostone in reducing intraoperative blood loss during abdominal myomectomy


Eligibility Criteria:
Inclusion Criteria:

* symptomatic fibroids candidate for abdominal myomectomy

Exclusion Criteria:

* patients candidate for laparoscopic or hysteroscopic myomectomy or had contraindications or allergy to dinoprostone or tranexamic acid
Second Opinions in Oncology

The long-time goal is to understand what decision-making process and patient characteristics factor into a patient deciding to stay with their initial physician versus seeking treatment with a second opinion.

The long-time goal is to understand what decision-making process and patient characteristics factor into a patient deciding to stay with their initial physician versus seeking treatment with a second opinion. To do this, the PI will examine the second opinion retention rates and patient characteristics of three distinct populations: breast cancer patients, pancreatic cancer patients and colorectal cancer patients. The study team hypothesize the majority of breast cancer and colorectal cancer patients who seek a second opinion at the University of Colorado, will preferentially choose to return to their first provider, whereas patients with pancreatic cancer who seek a second opinion at the sponsor's institution will be more likely to go on to receive care at the University of Colorado. The PI predicts the difference in second opinion retention rates between these three populations is due to the ability of the second opinion pancreatic cancer provider's ability to offer more treatment or a different treatment plan at the sponsor institution relative to the patient's first provider. The study team also predict that socioeconomic status and education will have a positive correlation with changing to with a second opinion physician whereas geographic distance and treatment plan similarity will have a negative correlation. The study team will assess this hypothesis by conducting a retrospective cohort study of breast, pancreatic, and colorectal cancer patients who received a second opinion at the University of Colorado. From this cohort, the study team will identify patients who both received their care at the sponsor institution and patients who returned to their initial provider to receive care. The study team will invite these patients to participate in semi-structured interviews to better understand how and why the patient made their treatment decisions.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients who are 18 years of age or older who received a second opinion at the University of Colorado.
* A subset of these patients will be invited to participate in semi-structured interviews

Exclusion Criteria:

* Patients under the age of 18.
* Patients who did not receive a second opinion at the University of Colorado.