cyrilzakka/clinical-trials huggingface dataset:
Melatonin Effects on Luteinizing Hormone

In many mammals, the duration of the nocturnal melatonin elevation regulates seasonal changes in reproductive hormones such as luteinizing hormone (LH). Melatonin's effects on human reproductive endocrinology are uncertain. It is thought that the same hypothalamic pulse generator may both trigger the pulsatile release of GnRH and LH and also cause hot flashes. Thus, if melatonin suppressed this pulse generator in postmenopausal women, it might moderate hot flashes. This clinical trial tested the hypothesis that melatonin could suppress LH and relieve hot flashes.

Twenty postmenopausal women troubled by hot flashes underwent one week of baseline observation followed by 4 weeks of a randomized controlled trial of melatonin or matched placebo. The three randomized treatments were melatonin 0.5 mg 2.5-3 hours before bedtime, melatonin 0.5 mg upon morning awakening, or placebo capsules. Twelve of the women were admitted to the GCRC at baseline and at the end of randomized treatment for 24-hour sampling of blood for LH. Morning urine samples were collected twice weekly to measure LH excretion. Subjective responses measured throughout baseline and treatment included sleep and hot flash logs, the CESD and QIDS depression self-ratings, and the SAFTEE physical symptom inventory.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman
* Troubled by hot flashes

Exclusion Criteria:

* Use of reproductive hormones other than continuous estrogen or progesterone hormone replacement
* Any acute illness
* Any anticipated changes of medication
* Anemia (hemoglobin \<12) or poor veins Recent trans-time-zone jet travel, shift work, or irregular sleep habits Any neurological or pituitary disease
Clinical Study to Evaluate the Effects and Safety of Green Tea Extract on Blood Glucose Regulation

This study was conducted to investigate the effects of green tea extracts on reducing blood glucose level

This study was conducted over 12 weeks with a randomized, double-blind, placebo-controlled, parellel design

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged between 19 to 64 years
* BMI between 18.5 and 29.9kg/m²
* fasting blood glucose between 100 and 139 mg/dL (Note: if some subjects with blood glucose range of 126 - 139 mg/dL, those who are taking or requre medication must be excluded to meet ethical standards.)
* subjects who voluntarily decide to participate in this study and sign the informed consent form.

Exclusion Criteria:

* Individuals taking to obesity, dyslipidemia, or uncontrolled hypertension at the screening
* Individuals diagnosed with diabetes and who have taken medications related to blood glucose
* Individuals congenital enzyme deficiencies related to sugar metabolism.
* with hypersensitivity to the test food or ingredients(e.g., green tea, caffeine).
* Individuals ongoing treatment diseases significantly related glucose metabolism.
* Individuals with a history of surgery significantly related to glucose metabolism within the last 6 months
* diagnosed with gastrointestinal diseases, cardiovascular diseases, uncontrolled chronic medical conditions, thyroid disorders, or active malignant tumors requiring medication
* Individuals with liver function impairment or acute or chronic hepatitis or liver cirrhosis
* Individuals with renal disorder
* Individuals with a weight change of 5 kg or more within the last 3 months.
Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening

The goal of this clinical trial is to learn the efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening. The main questions it aims to answer are:

* Efficacy of fractional 1064-nm picosecond laser for facial skin efficacy including the changes in wrinkle, nasolabial fold, skin laxity, and skin elasticity
* The changes in texture and pore volume using Antera
* The changes in bioengineering assessment: melanin index, erythema index, sebum level
* Adverse events Participants will be treated with 3 sessions of fractional 1064-nm picosecond laser (full face 4 passes, vector lines 4 passes), spaced 4 weeks apart. Follow-up visits 1, 3, and 6 months after the last treatments.

The efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening in participants aged 40 to 55 years, BMI \< 25 kg/m2, and have mild to moderate facial laxity.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40-55 years
* BMI \< 25 kg/m2
* Asian
* Mild to moderate facial skin laxity using quantitative grading scale (grade 1.5-2.5)

Exclusion Criteria:

* Pregnant or lactation
* Subjects who have been treated with any kind of energy-based device 6 months prior to the inclusion
* Subjects who have been injected with botulinum toxin, filler, or platelet-rich plasma on their faces 6 months prior to the inclusion
* Active skin infections
* History of hypertrophic scars or keloids
Computer-Based Training for Cognitive Enhancement: Classroom Study

The primary objective of this study is to evaluate the design and effectiveness of a computer-based training program on the memory and cognitive abilities of mature individuals undergoing healthy aging.

The purpose of this study is to test the new progressions design of a computer-based training program and to demonstrate the effectiveness of this refined cognitive training regimen on participants' performance on normed neuropsychological measures.

Subjects meeting eligibility criteria and providing written, informed consent will complete 40 one hour sessions of a computer based training program.

Eligibility Criteria:
Inclusion Criteria:

A)Participants must be at least 60 years old B)Participants must have a Mini-Mental State Exam (MMSE) score of 24 or higher to ensure that participants do not meet common criteria for dementia C)Participants must be a native English speaker D)Participants must be able to see well enough to read the consent form E)Participants must be able to hear well enough to understand ordinary spoken conversation when the clinical specialist holds a paper in front of his or her face to prevent the participant from lip-reading.

F)Participants must be willing to commit to the time requirements of the study and not have any scheduled trips or absences for more than 1 week during the training.

Exclusion Criteria:

A)Participants must not be planning to begin cholinesterase inhibitor (AChEI) therapy or to change their dosing levels. Subjects currently using AChEI will be included if they have an established steady dosing history at least one month prior to the study and are expected to continue at the same dosage throughout the study.

B)Participants must not have had a head trauma that caused them to lose consciousness in the past five years and have had no subsequent symptoms.

C)Participants must not have had a stroke within the past year; or have had a stroke that has left them with expressive or receptive language problems.

D)Participants must not have any central nervous system disorder that could contribute to cognitive impairment.

E)Participants must not have a tremor preventing the use of a computer mouse or other pointing device.

F)Participants must not currently be active in another clinical trial.
Safety and Feasibility Study of XAF5 Gel for Reduction of Submental Fat

This study will test the effects of XAF5 Gel (applied to skin each night for 6 weeks) on excess submental fat, also known as double chin. The study will also assess the safety and tolerability of XAF5 Gel.


Eligibility Criteria:
Inclusion Criteria (paraphrased):

* Adult men and women
* Must understand and provide informed consent
* Moderate submental fat (as determined by the clinician)
* No laxity (looseness) or minimal laxity of submental skin
* Healthy skin upon which a skin reaction would be visible

Exclusion Criteria (paraphrased):

* A clinically significant health problem or recent illness
* A clinically significant abnormal result on physical exam or laboratory tests
* Neck or facial hair that would interfere with applying the study drug to submental skin
* Clinically significant skin disease
* Body Mass Index (BMI) \>= 40
* Plan to begin a diet or weight loss regimen during the study
Auricular Acupressure and Limb Massage for Neuropathic Pain in Spinal Cord Injury

This randomized controlled trial included 90 patients with spinal cord injury, divided into an experimental group and a control group (45 each). The experimental group received auricular acupressure alongside rehabilitation therapy, while the control group received body acupoint massage alongside rehabilitation therapy. The intervention targeted specific auricular and body acupoints, performed three times daily, five days a week, for three weeks.

This study is a randomized controlled trial conducted in the rehabilitation ward of National Taiwan University Hospital, using a convenience sampling method. A total of 90 spinal cord injury patients who meet the inclusion criteria will be recruited and randomly assigned to either the experimental group (n=45) or the control group (n=45).

The experimental group will receive auricular acupressure in addition to rehabilitation therapy. The selected auricular acupoints include Shenmen (TF4), Subcortex (AT1), Liver (CO12), and Sympathetic (AH6a).

The control group will receive body acupoint massage in addition to rehabilitation therapy. The selected body acupoints include Quchi (LI11), Hegu (LI4), Sanyinjiao (SP6), and Zusanli (ST36).

Both groups will receive acupoint massage three times daily, with each acupoint being massaged for three minutes. The applied pressure will be adjusted to induce sensations of soreness, numbness, fullness, or mild pain. The intervention will be conducted five days per week for a total of three weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years old.
2. Spinal cord injury due to traumatic or non-traumatic reasons.
3. Within one year after spinal cord injury.
4. Spinal cord injuries are classified into ASIA grades B to D.
5. DN4 scale ≥ 4 points and PainDETECT scale ≥ 19 points.
6. Able to communicate in Mandarin and Taiwanese or able to read and write Chinese.

Exclusion Criteria:

1. The auricle and surrounding skin are injured, infected or susceptible.
2. Nerve block surgery has been performed previously.
Renal Osteodystrophy: A Fresh Approach

There are two major goals of this project:

1. Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss.
2. Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older;
* Chronic maintenance dialysis of at least 3 months' duration;
* Mental competence;
* Willingness to participate in the study;
* Calcidiol levels within normal range.

Exclusion Criteria:

* Pregnancy;
* Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus);
* Clinical condition that may limit study participation (e.g., unstable angina, respiratory distress, infections).
* Chronic alcoholism and/or drug addiction;
* Participation in a study of an investigational drug during the past 90 days;
* Allergy to tetracycline.
* Planning to move out of the area within 2 years of the study;
* On active transplant list;
* Treatment within last 6 months with drugs that may affect bone metabolism (except for treatment with calcitriol, vitamin D analogs and/or calcimimetics).
* Calcidiol level below the normal range. The current routine clinical practice in our dialysis clinics is to check calcidiol status twice yearly and supplement with vitamin D according to serum calcidiol levels. It is therefore unlikely that a substantial number of patients will be excluded due to this exclusion criterion.
Telemedicine as a Means to Achieving Good Diabetes Control Among Patients With Type 2 Diabetes

The aim of the study is to investigate the effect of telemedicine among the group of type-2-diabetics who, despite rehabilitation, remain poorly regulated. To describe the patients with regards to vulnerability and social resources and to determine wich groups benefit the most from telemedicine.

Type-2-diabetes is a growing healthcare problem. Both because of the increasing amount of patients and because of the complications of diabetes.

Non-pharmacological treatment is considered fundamental in the treatment of patients with type-2-diabetes.

In the Community of Copenhagen, all patients diagnosed with diabetes receive rehabilitation. The rehabilitation consists of counseling with regards to nutrition, physical activity, smoking cessation and education about diabetes.

Some patients however, remain poorly regulated despite rehabilitation as well as pharmacological treatment.

A total number of 165 patients will be randomized to intervention group or standard care.

Eligibility Criteria:
Inclusion Criteria:

* HbA1c \> 7,5%
* BMI \> 25
* Spoken danish
* Completed a rehabilitation program more than 6 months ago

Exclusion Criteria:

* HbA1c \< 7,5%
* BMI \< 25
* Need of interpreter
Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents

The purpose of this study is to check whether antimuscarinics that usually broadly used in the treatment of overactive bladder symptoms are effective in the treatment of those symptoms after insertion of ureteral stents. In order to study the efficacy of the treatment of OAB symptoms in stented patients the investigator will use a suitable questionnary.


Eligibility Criteria:
Inclusion Criteria:

* everyone who underwent ureteral stent insertion and started the treatment with detrusitol

Exclusion Criteria:

* adverse affects of detrusitol or unwillness of the patient to continue the treatment with detrusitol, cronic renal or hepatic failure
Inpatient Exposure Therapy and Response Prevention & Cognitive Remediation Therapy for Anorexia Nervosa

Exposure and response prevention (AN-EXRP) will help individuals with anorexia nervosa improve their eating behavior.

Anorexia nervosa (AN) is a serious illness associated with substantial morbidity and a mortality rate among the highest of any psychiatric illness. The rate of relapse is disturbingly high, with up to 50% of patients requiring re-hospitalization within a year of discharge. Current treatments are inadequate in helping older adolescents and adults achieve sustained recovery. Importantly, eating behavior remains disturbed after weight restoration: patients demonstrate restrictive eating in their self-selected foods and in standardized meals, and caloric intake in standardized meals is inversely related to pre-meal anxiety. Emerging data suggest that eating behavior is particularly important in post-hospital course, and that significantly altering eating behavior is critical in improving outcome for these individuals. Furthermore, caloric intake in standardized meals has been shown to be related to pre-meal anxiety. This study evaluates the potential utility of two psychotherapeutic interventions in improving eating behavior prior to hospital discharge. Each individual receives, in random order, Cognitive Remediation Therapy for 4 weeks and Exposure and Response Prevention for AN for 4 weeks. The investigators hypothesize that these interventions will lead to improvement in eating behavior, measured by food diaries and standardized meals.

Eligibility Criteria:
Inclusion Criteria:

1. DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype), with or without amenorrhea at the time of inpatient admission
2. Subjects will have achieved 85% of ideal body weight (IBW)
3. Age 16-45 years
4. No acute medical condition
5. Subjects must have signed informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

1. Psychotic or bipolar I disorder
2. Substance abuse or dependence in the last 6 months
3. Current Axis I disorder requiring psychotropic medication (ongoing antidepressant treatment for stable comorbid conditions will be allowed)
4. Significant co-morbid depression
5. Significant medical problems that would introduce additional risk related to research or interfere with participation, e.g. SBP\>140, DBP\>90, HR\>100 for a sustained period.
6. Active suicidal intent
Balance Training With TENS for Spastic Diplegic Cerebral Palsy

Children with spastic diplegic Cerebral Palsy (CP) often show motor impairment due to a number of deficits; including poor muscle control, weakness, spasticity and reduced range of motion in the extremities. All these factors affect the ability of children with CP to maintain balance and walk which are the primary rehabilitation concerns of parents and clinicians. The Balance Trainer provides a safe balance environment and assists with muscle activation of ankle and hip joints, and it is hypothesized that to promote spasticity inhibition, the use of TENS may decrease hyper-excitability, modulate reciprocal inhibition, and increase presynaptic inhibition. To the best of the authors' knowledge, the current study is the first research to investigate the effect of using Biodex balance training with TENS in improving children with spastic diplegia.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of spastic diplegia cerebral palsy.
* Age from 10 to 12 years.
* Spasticity grade 1 and 1+ according to the Modified Ashworth scale.
* Level II motor function according to the Growth Motor Function Classification System.
* Able to understand and follow instructions.
* Their heights are more than 100 cm and weights are more than 20 Kg which are the lower limits of height and weight needed by the Biodex stability system.

Exclusion Criteria:

* Epilepsy.
* Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
* Structural or fixed soft tissue deformities of the lower extremities.
* Neurological or orthopedic surgery in the past 12 months.
* Botox injection in the lower extremities in the past 6 months.
* Fracture, sprain, or strain injury of the lower extremities in the past 6 months.
Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias who have been eligible for, participated in and completed an AFQ056 phase II core study.

Exclusion Criteria:

* Surgical treatment for PD
* Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)
* Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations

Other protocol-defined inclusion/exclusion criteria may apply
A Study of Patients Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies

The purpose of this study is to assess the presence of anti erythropoietin antibodies (anti EPO Ab) in participants responding to any erythropoietin receptor agonist (ERA) therapy to treat or prevent anemia without loss of effectiveness to see if they will develop pure red cell aplasia or loss of effectiveness to recombinant erythropoietin and to measure the duration of effectiveness of ERA therapy.

This is an observational (study in which the investigators/physicians observe the participant's data and measure their outcomes), international, multicenter (study conducted at multiple sites), cohort (group of individuals with similar characteristics) study. The study consists of prestudy phase, observational phase (2 years), and follow-up phase (1 year). Approximately 50 participants who already receiving ERA therapy for anemia will be observed in this study. In the observational phase, participants' erythropoietin antibody status (positive or negative), clinical progress, treatment for anemia or prevention of anemia, and outcome will be monitored. During this study, enrolled participants will continue to receive standard-of-care treatment for their disease from their individual investigators as before enrollment to this study. Safety evaluations will include assessment of adverse events which will be monitored throughout the study. The total duration of the study will be 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Receiving any ERA therapy for any cause of anemia and having responded to the ERA therapy for at least 3 months
* Positive or borderline serum for antibodies to erythropoietin identified by serum radioimmunoprecipitation
* Maintained a stable hemoglobin within a 3-month period that has not decreased more than 2 g/dL in any 1-month period and with no increase in red blood cell transfusion requirement
* An ERA maintenance dose that has not increased more than 50 percentages from initial effective dose
* If blood count information is available, must have a count of reticulocytes (immature red blood cells) greater than or equal to 30 million/L

Exclusion Criteria:

* Stem cell or bone marrow transplantation
* Treatment with medication that decreases the ability of the immune system to function normally, within the last 3 months
* Participants who have shown a loss of effectiveness to ERA therapy, defined as participants who initially responded to treatment for anemia \[a rise in hemoglobin which lasted for a minimum of 3 months\] followed by an unexplained decrease in hemoglobin (greater than or equal to 2 g/dL) within a 1-month period
Exenatide and Basal Insulins Use in the Real Setting: an Observational Study in Patients With Type 2 Diabetes

Although the efficacy and safety profile of exenatide has been well established, few data exist on the real world results of exenatide treatment in specific populations and clinical settings. This study is intended to fill this gap through observing and collecting prospective data from a population of Italian patients initiating treatment with either exenatide or basal insulin formulations after failure to achieve glycemic control with oral antihyperglycemic agents (OHA).

Observational studies represent noninterventional research; therefore, this study does not involve randomization of patients to particular comparator arms or therapies. The term "noninterventional" means that the healthcare providers decisions regarding the proper treatment and care of the patient are made in the course of normal clinical practice. Patients enrolled in this study are enrolling for the collection of their data on observations made during normal clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Are inadequately controlled with single or multiple OHA as evidenced by an HbA1c \> 7.0%
2. Have presented during the routine course of care and, together with their physician, have decided to initiate treatment with either exenatide twice daily or conventional insulin therapy with basal insulin (insulin glargine, detemir, protaminated insulin lispro, protaminated human insulin) added to the existing treatment with OHA
3. Have not been treated with GLP-1 receptor agonist for more than 7 consecutive days within 3 months before entering the study
4. Have not been treated with insulins for more than 7 consecutive days within last 3 months or more than 3 months in the course of the disease
5. Are not simultaneously participating in another study which includes an investigational drug or procedure at study entry
6. Have been fully informed and given their written consent for use of their data