cyrilzakka/clinical-trials huggingface dataset:
Effect of 14 Day Bed Rest on Health Outcomes in Young and Older Participants

This investigation aimed to compare the response of older adult and young men to 14 day bed-rest and subsequent 28 day rehabilitation. Sixteen older (OM: 55-65 years) and seven young men (YM: 18-30 years) were exposed to 14-day bed rest (BR) followed by 14-day rehabilitation (R), and 400-day of R. Quadriceps muscle volume, force and explosive power of leg extensors, single fiber isometric force, peak aerobic power, gait stride length, and several metabolic were measured before and after BR and after R.

Twenty-three healthy men, of which 7 young (YM; aged 18-30 years) and 16 older adults (OM; aged 55-65 years) were recruited for the study. All participants underwent medical examination and routine blood and urine analysis. Exclusion criteria were: smoking; regular alcohol consumption; ferromagnetic implants; history of deep vein thrombosis with D-dimer \> 500 μg·L-1; acute or chronic skeletal, neuromuscular, metabolic and cardiovascular disease conditions; pulmonary embolism. Participants were informed of the purpose, procedures and potential risk of the study before signing the informed consent. The study was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki and was approved by the National Ethical Committee of the Slovenian Ministry of Health on April 17, 2012.

The study was conducted in controlled medical environment of the Orthopedic Hospital of Valdoltra, Slovenia. The participants were housed in standard air conditioned hospital rooms and were under constant surveillance with 24-hour medical care. For 14 days, the participants performed all daily activities in bed and received eucaloric controlled meals three times a day. Dietary energy requirements were designed for each subject multiplying resting energy expenditure by factors 1.2 and 1.4 in BR and ambulatory period, respectively. The resting energy expenditure was calculated as done in previous studies. The macronutrient food content set at 60% of carbohydrates, 25% fat, and 15% of proteins, according to the scheme of the so called "mediterranean diet" and adopted also in previous bed rest protocols. Energy balance was checked weekly by fat mass assessment. The daily protein intake was 1.1-1.25 g kg-1 in both groups, in BR and recovery period respectively, except the subgroups of OM who received a supplementation (see below).

After the BR, participants underwent a rehabilitation protocol (R) that consisted of 4-week supervised multimodal exercise program with 3 sessions per week. In each session, participants performed 12-minute warm-up, 15-20 minutes of balance and strength training, and 20-30 minutes of endurance training.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \< 28 kg/m2
* Short physical performance battery score \>= 9

Exclusion Criteria:

* smoking;
* regular alcohol consumption;
* ferromagnetic implants;
* history of deep vein thrombosis with D-dimer \> 500 μg·L-1;
* acute or chronic skeletal, neuromuscular, metabolic and cardiovascular disease conditions.
BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:

   * Evaluation of barium enema results
   * GI bleeding
   * Anemia of unknown etiology
   * Neoplastic disease surveillance
   * Abnormal Endosonography
   * Inflammatory bowel disease
   * Unknown diarrhea or constipation etiology
   * Polypectomy
   * Laser therapy
   * Routine screening
2. At least 18 years of age.
3. Otherwise in good health, as determined by physical exam and medical history.
4. If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, intra-uterine device, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse).
5. Negative urine pregnancy test at screening, if applicable.
6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study.

Exclusion Criteria:

1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.
2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
3. Subjects who are undergoing colonoscopy for foreign body removal or decompression.
4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
5. Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass).
6. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
7. Subjects of childbearing potential who refuse a pregnancy test.
8. Subjects who are allergic to any preparation components
9. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
10. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
Predictive Factors and Autonomy Level Change

The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The investigators aimed at developing a database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative personal and with the University hospital computer science department. The main objective is to study the predictive factors associated with the change of functional autonomy level, measured every 6 months to 12 months by phone, in a Memory Clinic. The study population would consist in about 1000 patients with ADRD. The length of follow-up of each patient will be 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo a medical visit in the Memory Clinic for the 1st time
* Patients living at home or in housing
* Patients with memory impairment, at all stage of the disease

Exclusion Criteria:

* Patients in institution
* Patients under legal protection
* Patients with a hearing or visual impairment, which dot not allow to carry out the examination
Follow-up of Patients After Knee Arthrodesis With an Intramedullary Nail

Follow-up of patients who underwent a knee arthrodesis with different types of intramedullary nails.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent a knee arthrodesis with an intramedullary nail between 1994 and 2005

Exclusion Criteria:

-
Effect of Baduanjin Exercise on Chronic Periodontal Disease in Elderly

The metabolic syndrome (MetS) is a spectrum of conditions that increase the risk of cardiovascular disease and diabetes mellitus. The components of MetS include dysglycemia, visceral obesity, atherogenic dyslipidemia (elevated triglycerides and low levels of high-density lipoprotein) and hypertension. An association of periodontal disease and MetS has been suggested. This association is believed to be the result of systemic oxidative stress and an exuberant inflammatory response.

Physical activity is associated as a potential tool for reduction of periodontal disease prevalence. The frequency of physical activity is directly related to a low occurrence of periodontitis.

For 6 months, MeTS elderly (25 elderly) with chronic periodontal disease will be involved in sixty-minute Baduanjin physical training (5 session weekly). Also, for 6 months, another MeTS elderly (25 elderly) with chronic periodontal disease will serve as a control non-trained group.

Eligibility Criteria:
Inclusion Criteria:

* fifty elderly with metabolic syndrome and chronic periodontal disease will be included
* both sexes will be included

Exclusion Criteria:

* smokers
* elderly engaged in physical activity programs
* any cardiovascular/respiratory diseases that obstacle the conduction of Baduanjin
* elderly on drug therapies for chronic periodontal disease
Mobile Applet for Weight Management in Obese Heart Failure Patients

The objective of this clinical trial is to investigate the effect of weight reduction through a diet management application and an intelligent weight scale on a composite cardiovascular endpoint in obese patients with heart failure.

The main questions are:

Does the use of a diet management APP and intelligent weight scale reduce 1-year all-cause mortality, heart failure hospitalization, and first heart failure hospital stay? Does the use of a diet management APP and intelligent weight scale improve the outcomes of assessment of heart failure frailty and quality of life for heart failure?

Researchers will compare using the fully functional diet management app and intelligent weight scale to using the limitedly functional app and intelligent weight scale to see if the app works to improve heart failure conditions.

Participants will:

Use the diet management app at every meal and the intelligent weight scale every day for 12 months, and visit the clinic at 12 months for checkups.

Obesity is one of the major risk factors for heart failure. Current guidelines for heart failure emphasize that severe obesity is associated with a poor prognosis in patients with heart failure, but there are no recommended effective interventions.

Caloric restriction alone, increased exercise, the use of weight-loss drugs, and bariatric surgery are not appropriate for obese patients with heart failure.

Whether obese heart failure patients with reduced ejection fraction (HFrEF) can benefit from weight loss treatment has not been evaluated in randomized controlled trials so far.

This study combines caloric restriction with lifestyle management to help HFrEF patients lose weight.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. Left ventricular ejection fraction (LVEF) ≤40%, NYHA grade II-III;
3. Body mass index (BMI) ≥ 28 kg/m²
4. Ability to use a smart phone and install the dietary management mobile app for adherence assessment through 2 weeks (± 1 week) induction period;
5. History of hospitalization for heart failure within the past 6 months;
6. Signed informed consent.

Exclusion Criteria:

1. End-stage heart failure (2 or more hospitalizations for heart failure in the past 3 months, or inability to tolerate guide-recommended drug therapy (GDMT), or positive inotropic drug dependence);
2. Moderate or above anemia (Hb\<90g/L);
3. Renal insufficiency (eGFR\<30 mL/min /1.73 m or undergoing dialysis;
4. Uncontrolled thyroid disease (hyperthyroidism/hypothyroidism) or end-stage liver failure;
5. Alcohol or drug abuse;
6. Taking drugs for weight loss or preparing for weight loss surgery;
7. Patients with malignant tumors whose life expectancy is less than 1 year;
8. Situations that researchers believe may hinder compliance with the program, such as habitually ordering takeout or eating in the company cafeteria;
9. Patients with planned hospitalization during the trial;
10. Participating in other interventional clinical studies.
Linear Focused Shockwave Treatment for Erectile Dysfunction

The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols.


Eligibility Criteria:
Inclusion Criteria:

1. Good general health
2. Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years.
3. International Index of Erectile Function 6 (IIEF-EF) between 17 and 25
4. Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors
5. Stable sexual relationship for at least 3 months prior to treatment
6. Minimum of two sexual attempts per month

Exclusion Criteria:

1. Hormonal, neurological or psychological pathology
2. Past radical prostatectomy or extensive pelvic surgery
3. Recovering from cancer during last year
4. Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
5. Clinically significant chronic hematological disease
6. Anti-androgens, oral or injectable androgens
7. Past radiotherapy treatment of the pelvic region
8. International normalized ratio (INR) \> 3 for patients using blood thinners (such as Coumadin)
A Trial Investigating the NN1250 Concentration-time Curve in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function

This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the NN1250 (insulin degludec/insulin 454) concentration-time curve is altered to such an extent that the dose should be adjusted in subjects with impaired renal function compared to the dose for subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Subject with normal renal function or renal impairment (mild, moderate, severe or end stage renal disease (ESRD) requiring haemodialysis)
* Body mass index maximum 40.0 kg/m\^2

Exclusion Criteria:

* Subject with any disease or condition which the Investigator feels would interfere with the trial except for conditions associated with renal impairment in the group of subjects with compromised renal function. Diabetes mellitus can be accepted in the group of patients with renal impairment, but not in subjects with normal renal function
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Significant history of alcoholism or drug/chemical abuse
* Not able or willing to refrain from smoking during the inpatient period
Assessment of the Acute Effect of IP

It is a nutraceutical system, consisting of oral tablet and an oral spray called Alpha GPC, which helps your body naturally restore the HGH levels.


Eligibility Criteria:
Inclusion Criteria:

* Males and females having age between 40-60 years (both inclusive)
* BMI ≥25 and ≤29.9 kg/m2
* FBS ≤ 120 mg/dl
* Serum hGH levels ≤0.94 ng/ml in females and ≤0.12 in males
* Thyroid Stimulating Hormone ≥ 0.35 and ≤ 5.55 mIU/ml

Exclusion Criteria:

* History of thyroid disorder (Hyper/Hypo).
* Smokers having at least 1 cigarette per day.
* Known hypersensitivity or allergy to one or more of the ingredients of the IP
* Participant suffering from primary or secondary insomnia with/without active treatment.
* Alcoholics as defined by consumption of more than 2 standard alcoholic drinks (more than 30 ml/ day) for past 3 months.
Retrospective Observational Study of Posterior Keratometry Measured

Keratoconus is a progressive bilateral disease leading to an apical stromal thinning and an irregular astigmatism by a steepening of the cornea, causing visual impairment. The causes are not yet well known, but it seems to be linked to several comorbidities. Keratoconus is a rare and for a long-time asymptomatic condition and its diagnosis needs meticulous screening for the early stages. Detecting it as soon as possible is a goal as it could lead to earlier avoiding of contributing factors such as eye rubbing and earlier treatment if needed.

The gold standard for keratoconus screening and staging is computerized videotography. It gives information about anterior and posterior corneal bulging, steepening, and thinning. It can be completed by anterior segment optical coherence tomography, which can show corneal scarring. Since recently, some biometry devices can give some information about the posterior corneal keratometry trough swept source optical coherence tomography measures. The measurement of the total corneal power instead of an extrapolation lead to better precision in refractive results after cataract surgery in some cases. It also helped to increase our knowledge about posterior corneal astigmatism. In normal eyes, average posterior corneal astigmatism is 0.37 diopters and against the rule in 91 percent of eyes. There is a correlation between the magnitude of anterior and posterior astigmatism.

In keratoconus eyes, several studies have shown that there is an alignment between axes of the anterior and posterior corneal astigmatism. These studies have been performed on computerized videotopography devices.

The goal of this study was to confirm or deny previous observations about posterior astigmatism in keratoconus eyes, and to assess if the rotation of axis between anterior and posterior astigmatism measured by IOL Master 700® can be a good sign for detection of early stages and fruste keratoconus.


Eligibility Criteria:
Inclusion criteria:

- Keratoconus diagnosed on videotopography

Exclusion criteria:

- loss of sight due to another condition than keratoconus, corneal scarring leading to lack or mistaken data, corneal graft, non-keratoconus related corneal ectasia such as post Laser in Situ Keratomileusis (LASIK) ectasia or keratoglobus
Dynamic Neck Function During Gait in Patients With Dizziness

This study aims to explore the possible association between dizziness and head-on trunk-movements and thus, neck movement and if this differs to healthy controls. Additional, the study will examine the reliability and validity of using wearable accelerometers to examine how the head moves relative to the trunk and to collect normative data on head on trunk movement.

Patients with dizziness will be recruited from a ear-nose and throat clinic. After giving written consent the patients will be tested with wearable sensors on their occiput and C6 vertebra during gait. Healthy controls will be recruited from students and employees at the Western Norway University of Applied Science and go through the same protocol as the patients.

The investigators will measure the relationship between the two sensors to explore how patients with dizziness move their-on-trunk during gait.

The projects main hypothesis is that patient with dizziness have reduced attenuation of gait-associated head oscillations with increased coupling of head-on-trunk motion, compared to healthy controls. The neck does not compensate for trunk movements, causing the head to follow the movement of the trunk.

Eligibility Criteria:
Inclusion Criteria:

Locally referred Patients to an ear-nose-and throat (ENT) clinic at an University Hospital for dizziness symptoms.

Exclusion Criteria:

Any severe neurologic or orthopedic disease affecting gait.
Efficacy and Safety Comparing 5% Monoxidil Milky Lotion Versus 5% Minoxidil Solution in Androgenetic Alopecia

5% Minoxidil lotion was approved for using to stimulate hair growth in male androgenetic alopecia by US FDA science 1988. The mechanism of action still unclear. In general the 5% Minoxidil in solution is the first choice preparation for treatment, therefore allergic contact dermatitis to solution was report up to 5.7% (Ebner H. et al,1995). Propylene glycol which is the main solvent of these solution, was the main responsible to allergic contact dermatitis with positive patch test up to 81.8% (Friedman ES. et al. 2002) One of the alternative solution using butylene glycol as the solvent was invented to solve the problem. In Siriraj hospital the investigators using this new solvent and made our in house product called 5% Minoxidil milky lotion. However the efficacy and safety of the new solution have not been investigated. This study is conducted to evaluated efficacy and safety of 5% Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.

The 5% Minoxidil in solution is the first choice preparation for treatment for Androgenetic Alopecia (AGA), 5% Minoxidil milky lotion is the alternative solution using butylene glycol as the solvent to solve allergic contact dermatitis problem. In Siriraj hospital the investigators using this new solvent and made our in house product called he efficacy and safety of the new solution have not been investigated. This study is conducted to evaluated efficacy and safety of 5% Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.

Eligibility Criteria:
Inclusion Criteria:

* New case male AGA
* Classification Norwood III vertex or IV

Exclusion Criteria:

* Have previous AGA treatment in 6 month prior
* Complicated case with other disease condition effect hair such as Anemia, DM, Chronic alcoholism, Autoimmune disease, Thyroid disease, previous GI surgery etc.
* Other scalp lesion such as Psoriasis, Tinea capsitis
* Psychological disorder including trichotillomania
Assessment of Safety, Tolerability and Efficacy of 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% Under Maximum-Use Conditions in Subjects with Primary Axillary Hyperhidrosis

The aim of this study is to investigate the safety, tolerability and efficacy of 1% GPB Cream compared to Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use under maximum use conditions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe primary axillary hyperhidrosis with a HDSS score of 3 or 4
* At least 50 mg of sweat production in each axilla measured gravimetrically at room temperature and at a humidity consistent with the normal climate in that area over a period of 5 minutes (patients should have acclimatized to that room for at least 30 minutes)
* Men and women aged 18 to 65 years at the time of informed consent with a body mass index of 18-32 kg/m2
* Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol subjects
* Willing and able to provide written informed consent

Exclusion Criteria:

* Known allergy to any of the components in the investigational product.
* Hypersensitivity against glycopyrrolate
* Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria, climacteric hyperhidrosis.
* Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery.
* Botulinum toxin treatment in the prior 4 months.
* Angle closure glaucoma or its precipitation (narrow angle).
* Mycotic, other skin infections and other dermal disorder including infection at anticipated application sites in either axilla.
* Any condition or situation that, in the investigator's or sub-investigator's opinion, may interfere with the patient's participation in the study