cyrilzakka/clinical-trials huggingface dataset:
Belotero Post Approval Study

A prospective, open-label 1-month post-approval study to evaluate the short term safety of Belotero® Balance in the re-treatment of nasolabial folds.


Eligibility Criteria:
Inclusion Criteria:

1. Was a participant in the Belotero® Balance pre-market IDE clinical trial or the Belotero Balance Fitzpatrick Skin Type IV-VI Study.
2. Is a candidate for bilateral nasolabial fold re-treatment with Belotero® Balance.
3. Understands and accepts the obligation not to receive any other facial procedures from enrollment through 1 month from optimal correction in the current study.
4. Understands and accepts the obligation to comply with the required follow-up visits and is logistically able to meet all study requirements.

Exclusion Criteria:

1. Has received surgery in either nasolabial fold.
2. Has received within the past 6 months a non-permanent filler (e.g. hyaluronic acid, CaHA) or neurotoxin below the zygomatic arch.
3. Has received at any time a permanent filler (e.g. polylactic acid, PMMA, silicone) below the zygomatic arch.
4. Has received within the past 6 months dermal resurfacing procedures (e.g. medium/deep chemical peel, dermabrasion treatments, ablative laser resurfacing) or non-invasive skin-tightening (e.g. Thermage) below the zygomatic arch.
5. Has received in the past 2 weeks prescription facial wrinkle therapies (e.g., RENOVA®), topical steroids, skin irritating topical preparations, or pigmenting agents (self-tanning agents) below the zygomatic arch.
6. Has received in the past 2 months or plans to receive during the study immunosuppressive medications or systemic steroids (intranasal / inhaled steroids acceptable).
7. Has an acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.
8. Has a known bleeding disorder or is using medication that reduces blood coagulation, (e.g. aspirin, non-steroidal anti-inflammatory drugs, or warfarin) which may increase the risk of bleeding during the treatment session.
9. Has a known history of severe allergies manifested by a history of anaphylaxis; or history or presence of multiple severe allergies.
10. Has known allergy or hypersensitivity to hyaluronic acid preparations, gram positive bacterial proteins or Belotero® or Belotero® derivative.
11. Has a known history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring.
12. Is a female of childbearing potential (e.g. not post-menopausal for at least one year or has not had a hysterectomy or tubal ligation) and is pregnant, lactating or plans to become pregnant during the study or is not using medically effective birth control.
13. Has any other medical condition with the potential to interfere with the study or increase the risk of adverse events.
14. Is enrolled or plans to enroll in a competitive or interfering study.
15. Is an employee or direct relative of an employee of the investigational site or study sponsor.
16. All Fitzpatrick skin types are eligible for study participation
The Leeds Women's Wellbeing (LWW) Study

The purpose of this parallel design study is to assess the relative effects of two 12-week healthy eating dietary interventions: general healthy eating (Diet A) and general healthy eating combined with advice to increase fibre intake (Diet B) to at least 25g/day (with a large proportion of the fibre intake derived from cereal or wheat bran), in overweight low-fibre consuming premenopausal female adults on body weight change (kg). It is hypothesized that adding fibre to a healthy eating diet (Diet B) would lead to greater weight loss and/or weight loss maintenance than following a healthy eating diet alone (Diet A).

In this randomised, single blind, parallel design study participants were randomly assigned to one of two 12-week healthy eating dietary interventions: Diet A: general healthy eating OR Diet B: general healthy eating combined with advice to increase fibre intake to at least 25g/day (with a large proportion of the fibre intake derived from cereal or wheat bran.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-48 years of age (premenopausal)
* Self reported good health
* Body Mass Index (BMI) within overweight/obese range (26-35kg/m2)
* Willingness to consume study foods and prepared to eat breakfast cereals as part of the intervention
* Non-smokers or given up more than 6 months ago
* Exercising no more than 4 times per week at a medium intensity
* Weight stable in the last 3 months (fluctuation of no more than 3kg)
* Current fibre intake (≤ 15g/day) according to DINE and verified by 7 day food diary (fibre points)
* Ability to adequately understand verbal and written information in English

Exclusion Criteria:

* Menopausal or showing menopausal symptoms (e.g. frequent/recurrent hot flushes) at screening or taking any supplements for menopausal symptoms
* Type 2 Diabetes; Cardiac pacemaker fitted
* Taking medication and/or supplements known to affect appetite/body weight in the last 6 months (e.g. asthma, steroids, anti-depressants)
* BMI outside range of 26-35 kg/m2
* Food allergies or aversions to foods likely to be consumed within the study (e.g. wheat bran, nuts)
* Non-smokers or given up more than 6 months ago
* Exercising more than 4 times per week at a medium intensity
* Shift work (night shifts)
* Pregnant or planning a pregnancy within the next year; having been pregnant or lactating within the previous 6 months
* No history of, or current eating disorders as determined using the Eating Attitudes Test (EAT-26;Gardner et al., 1982; a score higher than 20)
* Current fibre intake (\>15g/day according to DINE)
* Insufficient English language skills to complete all study questionnaires
Fibromyalgia: Interventions for Pain and Mood Regulation

This study compares the impact of cognitive-behavioral therapy for pain (CBT-P), mindful awareness and acceptance treatment (M), and arthritis education as an active control condition (E) on mental and physical health outcomes among adults with chronic pain due to fibromyalgia (FM).

Both cognitive-behavioral and mindful-acceptance based treatments impact pain and disability in people with chronic pain conditions like fibromyalgia. However, these treatments target different mechanisms. The focus of CBT is on helping individuals manage their thoughts and behaviors related to pain. In contrast, the focus of M is on improving individuals' ability be aware of and accept their experiences, and to develop their positive emotional resources.

Eligibility Criteria:
Inclusion Criteria:

* Pain in at least 11 of 18 tenderpoints
* Able to participate in study assessments and group-based meetings
* Willing to be randomized to treatment condition

Exclusion Criteria:

* Unable to understand written and spoken English
* Involved in pain-related litigation
* Currently involved in psychological treatment for pain and/or mood symptoms
To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function.

The objective of this study is to compare the pharmacokinetics of avanafil in subjects with mild and moderate renal impairment and to assess the safety and toleration of avanafil in subjects with mild and moderate renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* Adult male subjects,
* 21-78 years of age, must be medically healthy with no clinically significant screening results (except for the subjects in Groups 2 and 3).
* Subjects with normal renal function (Group 1) must have an estimated CLcr of ≥80 mL/min.
* Subjects with renal impairment (Groups 2 and 3) must fulfill the additional following criteria: (a) Stable renal impairment; (b) Group 2 subjects with mild renal impairment must have a CLcr of ≥50 to \<80 mL/min and (c) Group 3 subjects with moderate renal impairment must have a CLcr of ≥30 to \<50 mL/min.

Exclusion Criteria:

* Major exclusion criteria include: history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal (with the exception of renal insufficiency for subjects in Groups 2 and 3), hematological, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment; any clinically significant laboratory abnormalities as judged by the Investigator; systolic blood pressure \< 90 or \>160 mmHg; diastolic blood pressure \< 50 or \> 95 mmHg; allergy to or previous adverse events with PDE5 inhibitors or its constituents; use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome P450 3A4 enzyme within 30 days prior to Day 1; use of any investigational drug within 30 days prior to Day 1; use of any prescription or over-the-counter drugs or herbal remedies within 14 days prior to Day 1; history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breathe alcohol test; positive cotinine test, positive urine drug screen (except in renally impaired subjects following approval by Sponsor). Additional exclusion criteria are listed in Section 4.2.
Parental Attitude Toward Children Dental Treatment During COVID-19 Pandemic

The aim of this study is assessment of parental attitude toward children dental treatment and care during Covid 19- crisis

The recent spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its associated coronavirus disease has gripped the entire international community and caused widespread public health concerns.

Many countries all over the world including Egypt, have followed guidelines of limiting dental treatment for emergency cases only. However, as social distancing guidelines are starting to relax across many countries nowadays , dental offices start to reopen for elective procedures , many parents may still have a great concern regarding their children dental treatment during this pandemic. so the aim was to assess their attitude regarding their children dental visit

Eligibility Criteria:
Inclusion Criteria:

* Egyptian parents living in Egypt having children less than 16 years old

Exclusion Criteria:

* incomplete questionnaire
Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction

The Motiva Flora® TE are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months.

All Motiva Flora® TE's require periodic, incremental inflation with sterile saline for injection until the desired tissue amount is developed. After the desired volume, the expander is surgically removed and replaced with a long-term breast implant in the same space as the tissue expander.

The study collects retrospective data on the use of the Motiva Flora TE, from patients who had a tissue expander-based-breast reconstruction using the Motiva Flora® TE since market introduction in May 2020.


Eligibility Criteria:
Inclusion Criteria:

* Patient has completed a tissue expander-based breast reconstruction with the Motiva Flora® TE .
* Patient has been informed correctly according to to the applicable national and local regulations.

Exclusion Criteria:

* Not applicable
Temporal Profile of Serum Vitamin D Levels in Foot and Ankle Fusion Surgery

Vitamin D is important for bone health and recent research has emphasized the importance of adequate vitamin D levels for bone healing, wound healing, and possibly preventing infections post-operatively. This study will assess the effect of vitamin D supplementation on patient outcomes following ankle arthrodesis or first metatarsophalangeal joint arthrodesis.

The current status of knowledge includes preliminary research correlating hypovitaminosis, or low vitamin D status, to worse outcomes. In orthopaedic patients, vitamin D deficiency is prevalent among those scheduled to undergo surgery.

Vitamin D is important for calcium homeostasis and bone health, as well as for activation and differentiation of macrophages, dendritic cells, and lymphocytes. A recent retrospective review of outcomes in revision total joint arthroplasty patients showed that patients with low vitamin D had higher rates of postoperative complications and periprosthetic infections. Additionally, another retrospective study correlated low vitamin D levels with lower patient reported outcomes (PROs) after total hip arthroplasty. Current retrospective studies suggest that having low vitamin D levels may lead to impaired fracture healing, increased wound complication rates, and a higher risk of infections.

Given this background information, this study will investigate a series of patients undergoing ankle arthrodesis and first metatarsophalangeal joint (MTP) arthrodesis. Our study will serve to enhance the current knowledge as a level 1 randomized control study on the effect of Vitamin D supplementation on the complication rate following these two arthrodesis procedures. Our endpoints for complications will be defined as infection, wound healing complications, need for readmission, need for re-operation and nonunion as evidenced clinically and radiographically.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age
* Subject is undergoing ankle arthrodesis or MTP arthrodesis
* Subject speaks and understands English

Exclusion Criteria:

* Subject is \< 18 years of age
* Subject has an active joint infection
* Subject is unable to provide consent
* Subject is a prisoner
Muscle Response to Enzyme Replacement Therapy in Pompe Disease

This study is to study the response of muscle cells from Pompe disease after enzyme replacement therapy


Eligibility Criteria:
Inclusion Criteria:

* patients with Pompe disease, prepare or on enzyme replacement therapy
* signed informed consent

Exclusion Criteria:

-
Safety and Efficacy Study of CBT-004 in Patients With Vascularized Pinguecula

STUDY DESIGN:

Structure:

Multicenter, randomized, double-masked, vehicle-controlled, parallel-group study.

Duration of Treatment:

4 weeks of study treatment with 4 weeks follow-up observations.

Control:

Vehicle for CBT-004 (hereafter referred to as Vehicle).

Masking:

Subjects, Investigators, Study Monitors and the Independent Image Reading Center are all masked to the study medications.

Dosage/Dose regimen:

One drop of the assigned study medication will be administered in the study eye TID for 4 weeks. The study eye is defined as the qualified eye (i.e., the eye meeting the inclusion criterion for vascularized pinguecula). If both eyes are qualified, then the eye with the more severe vascularity grade at Visit 1 will be the study eye.


Eligibility Criteria:
Inclusion Criteria:

* Pinguecula with a vascularity grade ≥ 3 on a 5-point (0-4) scale.
* Ocular bothersome questionnaire score ≥ 2 on a 5-point (0-4) scale.
* ≥ 18 years of age.
* Able to provide written informed consent and comply with study assessments for the full duration of the study.

Exclusion Criteria:

* Uncontrolled systemic disease, in the opinion of the investigator.
* Active ocular disease other than pinguecula that may confound the study data, including but not limited to severe dry eye disease, pterygium, uncontrolled blepharitis, anterior membrane dystrophy, Salzmann's, glaucoma, or active ocular infection.
* History of ocular herpes disease, iritis/uveitis, in either eye.
* Any ocular surgical procedure within the last 3 months or anticipated ocular surgery during the study, in either eye.
* Anticipated wearing of contact lenses during any portion of the study. Patients, who wear soft contact lenses should discontinue wearing them at least 7 days prior to Day 1 visit. Patients wearing rigid gas permeable or hard contact lenses should discontinue wearing them at least 3 weeks prior to Day 1 visit.
* Female patients who are pregnant, nursing, or planning a pregnancy during the study.
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to entry into this study.
* History of myocardial infarction or stroke.
* Any condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
* Known allergy or sensitivity to the study medication(s) or its components.
* Current or anticipated use of topical ophthalmic medications in the study eye. Patients must have discontinued use of ophthalmic medications in the study eye for at least 2 weeks (4 weeks for Restasis® or Xiidra®) prior to Day 1 visit. Artificial tears are allowed in the study eye until 7 days prior to Visit 1 and should not be used during the treatment phase of the study.
Evaluation of Adults With Endocrine and Metabolic-Related Conditions

Background:

There are many endocrine and metabolic-related conditions. Two well-known disorders include diabetes and thyroid disease. Some of these diseases are caused by a change in genes. Researchers want to identify the genes involved in these disorders. They hope this will help them learn more about these diseases.

Objectives:

To learn more about conditions that affect the hormone-secreting glands (endocrine glands) in adults. To train doctors to diagnose and treat people with endocrine or metabolic conditions.

Eligibility:

Adults age 18 years and older with a known or suspected endocrine disorder.

Relatives ages 18 years and older.

Doctors will review all requests and available medical records to determine final eligibility for the protocol.

Design:

Participants will have a medical history and physical exam.

Most participants will have 1 visit, and may have follow up visits if necessary. They may have tests, surgery, or other procedures to help diagnose or treat their condition. These could include:

* Blood, urine, and saliva tests
* Imaging tests. These may include X-ray, ultrasound, or scans.
* Sleep study
* Medical photographs
* Visits with other specialists at NIH

Participants will provide blood, urine, saliva, or tissue samples. Some of these samples may be stored in the freezer for future studies.

Participants may be asked to participate in genetic testing. They will give a blood or saliva sample for this.

This is an observational protocol designed to collect data from adult subjects with known or suspected endocrine or metabolic disorders.

OBJECTIVE: The overall purpose of endocrine evaluations under this protocol is to increase knowledge of endocrine or metabolic diseases. Adults with known or suspected endocrine or metabolic-related condition(s) may be evaluated under this protocol for:

1. Collection of data for endocrine related conditions (case reports, case series)
2. Collection of data for future research
3. Collection of samples, including leftover samples from clinically indicated tests, for future research (including genomics)

METHODS: Patients will undergo a history and physical exam, anthropometrics, vital signs and endocrine laboratory studies.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Participants with known or suspected endocrine disorder age 18 years and older are eligible for this protocol. Protocol investigators will make the actual selection of subjects most appropriate for clinical evaluation.
* Relatives ages 18 years and older may be enrolled if clinically indicated for the diagnosis of a proband.

EXCLUSION CRITERIA:

* Anyone under the age of 18 years old
* Any medical, physical, psychiatric, or social conditions, which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the subject. Subjects who are critically ill, unstable, or with severe organ failure that may affect/limit the endocrine evaluation and place unsustainable demands on Clinical Center or NIDDK resources.
Weight Loss Intervention for the Reduction of Cancer Risk and Health Disparities in Rural Ohio

This study determines the feasibility of a telephone-based weight lost intervention in reducing cancer risk and health disparities in rural Ohio. Obesity is the leading preventable cause of cancer, and obesity-related inflammation is linked to elevated cancer risk, independent of obesity itself. Rural populations are a vulnerable population in need of increased access to tailored strategies and benefit from weight loss interventions. This study aims to see whether a telephone-based intervention may help obese people in rural area to reduce body weight, so as to prevent obesity-related cancer.

PRIMARY OBJECTIVES:

I. To determine the feasibility and acceptability of a 15-week telephone-based weight loss intervention among overweight/obese rural residents.

II. To estimate the preliminary efficacy of the lifestyle modifications on weight loss, body composition (fat mass, percent body fat), inflammatory biomarkers (IL-6, TNF-alpha, and C-recreative protein \[CRP\]), and other disease risk factors (lipid profiles).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive weekly telephone-based weight loss intervention for 15 weeks, including dietary recommendations tailored to their current weight and weight loss target, home-based aerobic and resistance exercise, and weekly telephone counseling session over 30-45 minutes.

ARM II: Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \>= 25 kg/m\^2
* Age: 20-64.9 years
* Not currently participating in any weight loss intervention or meet the physical activity recommendation (150 min/week of moderate-intensity exercise or 75 min/week of vigorous exercise)
* The ability to walk two blocks
* Ability to speak and read English

Exclusion Criteria:

* Prior cancer diagnosis (except non-melanoma skin cancer) or severe medical conditions such as unstable cardiovascular disease or digestive disorders that would preclude physical activity and dietary intervention
* Pregnant or nursing women
* Unable to give informed consent
Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with spinal cord injury


Eligibility Criteria:
Inclusion Criteria:

* Subjects who understand and sign the consent form for this study
* Age : 19-70
* Clinical diagnosis of spinal cord injury(American Spinal Injury Association\[ASIA\] Impairment Scale\[AIS\] grade A or B or C)
* Duration of injury : \> 3 month

Exclusion Criteria:

* Subjects who must put on a respirator
* Subjects who had malignant tumor within 5 years
* Subjects with a infectious disease include HIV and hepatitis
* Subjects who injured brain or spinal cord before spinal cord injury
* Subjects with anemia or thrombocytopenia
* Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease
* Subjects with congenital or acquired immunodeficiency disorders
* Patients with clouded consciousness or speech disorder
* treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials
* participating another clinical trials within 3 months
* other serious disease or disorder that could seriously affect ability to participate in the study