cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Facial Growth in Two Primary Protocols Used in the Surgical Treatment of Unilateral Cleft Lip and Palate Patients

The purpose of this study is to evaluate which surgical protocol for treating Unilateral Cleft Lip and Palate (UCLP), a single or two stage repair ( with hard palate late closure) will have less impact in mid facial growth.

The study hypothesis states that a two stage cleft palate repair , with a late hard palate repair will reduce maxillary growth impairment.

The study is being conducted at CADEFI- Centro de Atenção aos Defeitos da Face do IMIP (craniofacial center) in IMIP-Instituto de Medicina Integral Professor Fernando Figueira-, Recife PE- Pernambuco-, Brazil. All children were and will be operated by the same plastic surgeon in the operating room in IMIP. The sample size was calculated in 64 patients, 32 to GI ( one stage repair) and 32 to GII ( two stage repair, with a hard palate late closure), considering taking a statistical power of 90% with a 5% significance, determined with a difference of at least 25% between the two groups. Note : this sample was calculated for the dependent variable commonly present in patients with unilateral lip and palate cleft : atresia of the dental arches.

The groups are numbered in post op care attendance of the lip repair, according to randomization sequence done in computerized statistical program. The randomization is being held after the first month of the lip repair surgery. The surgeon, and parents or guardians (who have already signed the Informed Consent Form) will not have prior access to information on the type of allocation in each group. Subsequently it will be added in patients chart the record set for the patient group.

\>Study Variables Independent variables:. Group I (palate closure in two surgical times and GII (closure of the palate in a surgical time) also will be considered independent variables age, sex, birth weight and maternal education.

Dependent variables: the presence of postoperative infection, initial and intermediate cleft sizes, dimensional changes of the transverse arch, the evaluation indexes of dental arch relationship(Goslom,Atack Yardsticks) and speech outcomes evaluation grades

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral cleft lip and palate admitted consecutively in CADEFI-IMIP between August 1, 2011 and July 31, 2015

Exclusion Criteria:

* Patients with associated syndromes that retard the neuro-psycho-motor and speech development;
* Patients without clinical conditions for performing the surgical chronology protocol;
* Patients whose parents or guardians who are not in accordance with the Informed Consent Statement proposed by the researcher
Physical Activity Level and Insomnia

This study aims to investigate the relationship between physical activity levels and insomnia in females with primary dysmenorrhea.

This study will be designed as a case-control study, conducted on 150 females recruited from El_Nassr hospital in Helwan, Cairo, Egypt and from social media. Patients will be divided into two equal groups: group A(75 patients complain from PD according to WaLIDD score)\& group B(75 patients don't complain from PD according to WaLIDD score). All data and information of each female in this study, including name, age, address, weight, height, and menstrual history, will be recorded in a recording data sheet. WaLIDD score will be used to assess PD symptoms, Insomnia Severity Index will be used to assess insomnia, International Physical Activity Questionnaire (Short-form)\& Six-Minute Walk Test will be used to assess physical activity levels. Inclusion criteria: 1)Patient ages will be ranged between 18-25 years old, 2)They do not receive any drugs, 3)Being a virgin. Participants will be excluded if they 1) Using hormonal contraception (such as oral contraceptives and injections), 2)Taking any medications, 3)History of chronic disease, 4)Having any psychiatric or gynecological problems (such as PCO, amenorrhea, women who suffered from menopause). The subject, who missed for any of assessment session, would be withdraw form the research.

Eligibility Criteria:
Inclusion Criteria:

1. Patient ages will be ranged between 18-25 years old.
2. They do not receive any drugs.
3. Being a virgin .

Exclusion Criteria:

1. Using hormonal contraception (such as oral contraceptives and injections).
2. Taking any medications.
3. History of chronic disease.
4. Having any psychiatric or gynecological problems (such as PCO, amenorrhea, women who suffered from menopause).
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia

Homonymous lateral hemianopia (HLH) is characterized by loss of vision in half the visual field, and is the most common neurovisual disorder following stroke.

Numerous behavioral and neuroanatomical studies have focused on the phenomenon of blindsight, corresponding to patients' unconscious residual visual capacities in the blind hemifield. Cohort studies of patients have highlighted different types of blindsight, and a low occurrence of the phenomenon initially described: (1) type 1 blindsight (≈12%), unconscious visual abilities; (2) type 2 blindsight, visual abilities associated with sensations in the blind field (≈18%); (3) blindsense, sensations in the blind field without visual abilities (≈30%); and (4) no blindsight (≈40%). The heterogeneity of these blindsight abilities in the HLH population is closely related to patients' neuroanatomical and functional profiles.

In particular, resting-state functional imaging (r-fMRI) and default mode network analysis have highlighted a significant correlation between the degree of inter-hemispheric connection (between the healthy and injured hemispheres) and the rate of spontaneous visual field recovery. To our knowledge, this degree of functional connectivity has not yet been studied in relation to blindsight abilities. However, this functional MRI measurement tool represents a potential predictive factor for patients' residual performance in their blindsight field, in order to assess the level of visuo-cognitive impairment and, ultimately, to adapt care.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 and over
* with homonymous visual field amputation sequelae of a retrochiasmatic lesion of vascular origin (stroke), including the occipital region (primary visual cortex, optic radiations, associated occipital areas)
* Requires follow-up brain MRI as part of treatment
* Able to perform experimental tasks on computer
* Express consent to participate in the study
* Member or beneficiary of a social security scheme

Exclusion Criteria:

* Severe neuropsychological disorders (language, memory, attention, vigilance, reasoning)
* Severe ophthalmological disorders or visual acuity below 3/10 prior to stroke
* Progressive ophthalmological disorders (cataract or glaucoma) likely to bias measurements
* Major psychiatric or behavioral disorders making care impossible
* Patient benefiting from a legal protection measure
* Pregnant or breast-feeding women (declarative information)
The Effect of Food Supplements on Food Intake and Gut Hormone Levels

When a meal is eaten, nutrients activate the release of hormones from the bowel into the blood stream. Normally there is a large amount of hormone released, which tells the brain that an individual is full and to stop eating. When people gain weight and become overweight or obese, these hormone signals are reduced, resulting in these people eating more and gaining more weight. This study is investigating mechanisms which may break this cycle by using particular nutrients to restore reduced hormone levels.


Eligibility Criteria:
Inclusion Criteria:

* Obese but otherwise healthy volunteers,
* body mass index (BMI) of 30-40 kg/m2
* agreement to consume scheduled meals
* ability to understand the study information sheet and instructions in English and able to provide informed consent.

Exclusion Criteria:

* Not meeting any of the exclusion criteria above.
* Major gut surgery
* Major health problems
* Taking medication for diabetes
A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence

The purpose of this study is to monitor the use of Virtue® Male Sling in a real world population and collect medical data on effectiveness and to monitor safety of Virtue® at 12 and 36 months post device implantation in men with post-prostatectomy urinary incontinence.

This project will be launched after the first introduction of Virtue® Male Sling in Europe. This study is a multicenter prospective, non-interventional (i.e. naturalistic) post-marketing clinical follow up of men with urinary incontinence implanted with Virtue® Male Sling System by urologists who are experienced in the device. The patient will be followed for 12 months in routine real world clinical practice except for administration of subject questionnaire(s). Routine visits will be performed approximately at baseline (preoperative and implantation period), between 1 and 3 months (immediate post-operative period) and 12 months. Then questionnaires will be mailed annually during 2 additional years.

Eligibility Criteria:
Inclusion Criteria:

* Implanted with the Virtue® Male Sling System

Exclusion Criteria:

* Refuses to be included in the survey or that their medical data will be used for research purposes.
* Indication for the Virtue® Male Sling System implantation is not for the treatment of male urinary incontinence
A Clinical Study to Determine Biomarkers of Response to a Gamma Secretase Inhibitor

The purpose of this study is to determine the transcriptional signature of Notch Inhibition by testing hair and blood samples on healthy male volunteers who have received MK0752 vs placebo for possible future biomarkers in the treatment of cancer or Alzheimers Disease


Eligibility Criteria:
Inclusion Criteria:

* Patient is a male
* Patient has no clinically significant abnormality on electrocardiogram performed
* Patient agrees to not to consume apple juice, grapefruit or grapefruit products beginning 2 weeks prior to first dose of study drug and for the duration of the study
* Patient has been a nonsmoker and/or has not used nicotine or nicotine-containing products for approximately 6 months.
* Patient is willing to not use any hair enhancement product or procedures for the duration of the study (for example, permanents, hair straightening techniques)
* Patient has a full head of hair
* Patient has at least 90% non-gray hair

Exclusion Criteria:

* Patient has had treatment with any investigational therapy during the prior 21 days
* Patient has any history of significant gastrointestinal abnormalities within the last 10 years
* Patient has a history of any long-term or active liver disease including elevated liver blood tests. Any patient with a history of Hepatitis B or C (and/or treated previously) will be excluded
* Patient has a known history or family history of aortic valve disease, congenital (from birth) heart disease or deafness, hearing loss or early onset Alzheimer's disease (onset at age \< 55)
* Patient has a known sensitivity to the ingredients in the drug
* Patient has had active and uncontrolled infection within the past month
* Patient is HIV positive
* Patient has a history of stomach, intestine, heart, blood, liver, brain, kidney, lung, bladder or endocrine abnormalities or diseases
* Patient has a history of cancer except for certain skin cancer (basal cell)
* Patient has a history of multiple and/or severe allergies or has had an allergic reaction to food or prescription/non-prescription drugs
* Patient has had major surgery, donated or lost 1 unit of blood (about 500 mL) within the past month
* Patient has premature graying hair (\> 10% gray hair)
* Patient has male pattern hair loss
* Patient has a prior history of high blood pressure
* Patient uses any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's Wort) beginning approximately 2 weeks prior to the first dose of study drug, throughout the study until the post study visit
* Patient consumes excessive amounts of alcohol (greater than 3 glasses of alcoholic beverages)
* Patient consumes excessive amounts (greater than 6 servings) of coffee, tea, cola or other caffeinated beverages per day
* Patient is a regular use (including "recreational use") of any illicit drugs, has a positive urine drug screen before randomization or has a history of drug (including alcohol) abuse within approximately the past 2 years
* Patient has prior exposure to MK 0752 with the past 21 days
How to Improve Diagnosis in Infective Endocarditis

The purpose is to exam prospective if simple clinical information in combination with a normal s-procalcitonin are sufficient for exclusion of infective endocarditis (IE).

Despite progress in surgical and medical treatment, infective endocarditis is still associated with high morbidity and mortality.

The variable clinical presentation of IE makes the diagnosis a clinical challenge.

Procalcitonin is a precursor from the hormone calcitonin and also a marker of systemic bacterial infections.

The purpose of this study is:

* to investigate the diagnostic value of serum procalcitonin (PCT), C-reactive protein (CRP) and sedimentation rate (SR) when IE is suspected.
* to investigate if a retrospectively generated clinical model suitable for exclusion of IE can be confirmed prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> or = 18 year with suspected or verified Infective Endocarditis
* By word of mouth or in writing consent

Exclusion Criteria:

* Incapacity
Feasibility and Practice Characteristics of FNS and Gait Robot

Conventional therapies do not restore normal gait for many stroke survivors. The long-term goal of this work is to restore volitional lower limb motor control and gait following stroke. In our prior work, we demonstrated that it was feasible to provide a clinically operated, combined treatment of body weight supported treadmill training alone (BWSTT) + functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM).

Specific Aims and Hypothesis The purpose or Specific Aim of the study is to test the feasibility and gait training potential of combining the Lokomat and FNS-IM for stroke survivors. Given the feasibility of our clinically operated combination of BWSTT + FNS-IM, we propose to test the feasibility of the combination of Lokomat + FNS-IM.

Hypothesis I. It is feasible to utilize a clinically operated combination of Lokomat + functional neuromuscular stimulation (FNS) with intramuscular (IM) electrodes (FNS-IM).

Treatment Procedures. The subjects will be treated for three months, four sessions/week (for a total of 48 treatment visits). A given session will be 1 hrs, with the time divided into thirds as follows: 1) hr coordination exercise; 2) hr over ground gait training; and 3) hr Lokomat gait training. FNS-IM will be used in all three aspects of the protocol, unless the subject is capable of volitionally executing a given movement or gait component. Population. The subjects will be chronic stroke survivors (\>6 months after the stroke).


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 6 months after stroke
* 21 years or older
* Ability to follow 2 step commands
* Inability to move leg normally

Exclusion Criteria:

* Pacemaker
* Progressive medical condition (i.e. Parkinsons Disease)
Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice. Phase 1.

With the growth of hospice, older adults have the opportunity to receive home-based care aimed at reducing suffering and focusing on quality of life at the end of life. While use of technology and educational videos has yet to be fully developed, structured, and evaluated in home hospice care, it has shown promise to improve care in other settings. Therefore, this study aims to develop and evaluate a multi-component technology-based care intervention, i.e., Improving Home hospice Management of End of life issues through technology (I-HoME), that focuses on assessing and addressing patient symptoms and caregiver burden in the home hospice setting through synchronous live video visits and educational videos. The aim of the first phase of the project is to employ an iterative user-centered design process to develop I-HoME for home hospice patients and their caregivers prior to implementation.


Eligibility Criteria:
Inclusion Criteria:

* Home hospice providers (N=10) and family caregivers (N=10) must be English speaking, 18 years of age or older, not blind, and either providing or receiving home hospice care. Home hospice patients (N=10) must be English speaking, 65 years of age or older, not blind, and enrolled in home hospice care.

Exclusion Criteria:

* Patients with a terminal diagnosis of dementia or patients who have cognitive impairment and unable to sign a written informed consent will be excluded.
Precision Assessment of Platelet Rich Plasma for Joint Preservation

Knee Osteoarthritis (OA) is a leading cause of premature disability in Veterans who develop knee OA at higher rates and younger ages than the population in general. For those with symptomatic early knee OA, who are years to decades away from meeting clinical indications for knee replacement surgery, knee injections have been a key treatment option. In recent years, platelet rich plasma (PRP) injections have gained increasing attention for improving pain and function in patients with knee OA. Basic science studies also suggest that PRP may also potentially stimulate repair responses to articular cartilage. However, the mechanisms of action of PRP in the treatment of knee OA are unknown. Because autologous blood is used, the PRP composition differs between patients. It is also unknown whether these differences in PRP composition affect clinical outcomes. This study will address these gaps and provide critical new and objective information on PRP treatment effects in Veterans and additional women with early knee OA important to improving clinical use of this new treatment.

Because very little is known about either the mechanisms of action or objective clinical outcomes of PRP treatment for knee OA, the investigators propose a prospective "pre-post" study that will permit us to identify areas where more rigorous clinical outcomes and mechanistic research may be warranted. The proposed work includes special elements of: (1) quantitative metrics to assess clinical outcomes, (2) correlation of candidate beneficial proteins with clinical outcomes, and (3) proteomic evaluation of the injected PRP. This work will use an innovative multi-disciplinary, personalized approach to evaluate the effects of PRP composition on both function, as assessed by patient-reported outcomes and gait analysis, and cartilage matrix structure as assessed by quantitative MRI

Eligibility Criteria:
Inclusion Criteria:

* symptomatic early knee OA
* full weight-bearing status
* have elected to receive PRP treatment
* Male veterans
* Female veterans

Exclusion Criteria:

* inflammatory arthritis, gout or recurrent pseudogout
* symptomatic OA of other lower extremity joints
* BMI \>35 kg/m2
* use of walking, orthopedic, or prosthetic assistive device
* severe systemic disease defined as American Society of Anesthesiologists (ASA) 3 or above56
* inability to have MRI
* pregnant or intending to become pregnant during the study
* predominantly patellofemoral disease
Effect of Vitamin D Treatment in Primary Hyperparathyroidism

The primary aim of the study is to assess whether 6-months of vitamin D supplements can decrease PTH compared with placebo treatment in primary hyperparathyroidism.

The study investigates effects and safety of six months of vitamin D supplementation before and after surgery in primary hyperparathyroidism. Effects are assessed as changes in calcium homeostasis, bone metabolism, quality of life, and muscle strength and function.

Eligibility Criteria:
Inclusion Criteria:

* P-Ca-ion \> 1,30 mmol/l
* P-PTH \> 5 pmol/l
* P-OH25-vitamin D \< 80 nmol/l

Exclusion Criteria:

* P-creatinin \> 120 mumol/l
* usage of Etalpha, Mimpara
* Cancer
* Sarcoidosis
* malabsorption
* pancreatitis
* alcohol abuse
* pregnancy
Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications

The purpose of this study is to observe the effects of certain anti-HIV medications on mitochondrial activity and fat cell death. This study will enroll participants from another study, ACTG A5202, who are on treatment regimens that do not include zidovudine, stavudine, or other thymidine-containing anti-HIV medications.

The main objective of this study is to observe the effects of anti-HIV medication lacking thymidine on mitochondrial metabolism and adipocyte apoptosis (fat cell death). Changes in mitochondrial metabolism and increases in adipocyte apoptosis are associated with lipoatrophy. Lipoatrophy is a common condition characterized by loss of subcutaneous fat and can be caused by many anti-HIV medications. This study will examine the metabolic consequences of the use of thymidine analogue-sparing treatment regimens.

This study will evaluate HIV infected patients who are enrolled in ACTG A5202, starting their first nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen. This regimen will include either tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or abacavir/lamivudine (ABC/3TC), which are thymidine-sparing regimens. The changes in mitochondrial activity and fat cell death will be compared between participants taking thymidine-sparing regimens (TDF/FTC or ABC/3TC) and thymidine-containing regimens.

This study will last for 96 weeks, with two study visits occurring at entry and another visit at Week 96. During each visit, a dual energy x-ray absorptiometry (DEXA) scan and blood collection will occur, and a fat biopsy will be performed in the lower abdomen under local anesthetic.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* Enrolling in ACTG A5202 and its metabolic substudy ACTG A5224

Exclusion Criteria:

* Bleeding problems
* Cannot undergo fat biopsies
* Require aspirin anytime in the 7-day period prior to each biopsy