cyrilzakka/clinical-trials huggingface dataset:
The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women

The primary aim of this study is to test whether type 2 diabetes interacts with estradiol on brain metabolism in vivo in humans. This will be accomplished by imaging brain metabolism using positron emission tomography before and after short-term administration of transdermal 17β-estradiol in 10 postmenopausal women with diabetes and 10 non-diabetic postmenopausal women.

Epidemiological studies suggest there may be an interaction between type 2 diabetes and estrogen in postmenopausal women, such that diabetes may interact with estrogen levels over time to increase risk for dementia. The mechanism for this effect is now known. However, animal research suggests that it may occur through estrogen's effects on cellular metabolism of glucose and ketone bodies. The primary aim of this study is to test whether type 2 diabetes interacts with estradiol on brain metabolism in vivo in humans. This will be accomplished by imaging brain metabolism using positron emission tomography before and after short-term administration of transdermal 17β-estradiol in 10 postmenopausal women with diabetes and 10 non-diabetic postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to provide written informed consent
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Female, postmenopausal, aged 60-80
4. Normal results on recommended healthcare screenings (e.g., mammogram, pap smear, colonoscopy)
5. BMI 20-35 kg/m2
6. No evidence of dementia or mild cognitive impairment (MoCA score \>25)
7. Able to access reliable transportation to study and intervention visits

Exclusion Criteria:

1. Use of hormone replacement therapy within the past 3 months
2. History of renal, heart, liver, or neurological disease; head injury with loss of consciousness in the past 5 years; chronic pain, anxiety or depression
3. Presence of medical conditions that might contraindicate estrogen use (e.g., unexplained vaginal bleeding, history of reproductive tissue cancer, thrombosis)
4. Currently taking insulin, metformin, or any other drug or medication judged by the study physician to affect safety or research outcomes of interest
5. Involved in another research study
6. Contraindications for MRI or PET scanning
7. Current smoker
Does Dexamethasone Administration Improve Recovery In Patients Undergoing Minimally Invasive Sacrocolpopexy?

The primary aim is to evaluate whether standard administration of Dexamethasone at the time of general anesthesia induction at the time of minimally invasive sacrocolpopexy (MISC) would result in improved quality of recovery (QoR).

There has been a public outcry regarding the continuing rise of health care expenditures. In 1997, the estimated costs of surgery for pelvic organ prolapse (POP) were $ 100.1 million. It is important to identify interventions that would improve the QoR in this patient population and to speed-up postoperative recovery. As most of these surgeries are performed in an outpatient manner as a 23 hour observation, improved recovery may also speed discharge and free-up valuable hospital resources.

Patients will receive either Dexamethasone or placebo ( normal saline) at the time of induction of general anesthesia. QoR questionnaires, Pain scale and postoperative nausea and vomiting scale (PONV).

Eligibility Criteria:
Inclusion Criteria:

1. Women over the age of 18
2. Women scheduled for minimally invasive sacrocolpopexy with or without concomitant anti-incontinence procedure and with or without concomitant hysterectomy
3. American Society of Anesthesiologists (ASA) class 1-2

Exclusion Criteria:

1. Daily use of steroids, antiemetics in the month prior to surgery
2. Chronic pain requiring daily opioid treatment
3. History of allergy/intolerance to Dexamethasone
4. ASA class 3
5. Numerical Pain score (NPS) of more than 4 at baseline
6. Renal/Liver disease
7. Diabetes mellitus
8. Pregnancy
9. Inability to answer questionnaires
10. Any systemic infections
11. Immuno compromised status
The Effects of Two Types of t-DCS Stimulation on Robot-assisted Gait Training in Patients With Multiple Sclerosis

The primary aim of this study is to determine the transcranial direct current stimulation and transcutaneous spinal direct current stimulation in addition to robot-assisted walking training in individuals with Multiple sclerosis; to examine the effects on motor functions against each other and sham application. Secondary aim of this study is to show the relation of these effects with tDCS and ts-DCS through fatigue and quality of life evaluations.

These study is planned to be carried out in the Cadde Medical Center clinic. The patients who will participate in the study will be determined according to the inclusion criteria among the patients who applied to the Multiple Sclerosis Outpatient Clinic of Istanbul Medeniyet University Göztepe Research Hospital, Department of Neurology. As a result of the power analysis, 36 participants were planned to be included in the study. 20 minutes of non-invasive brain stimulation will be applied to the individuals participating in these study before the 20 minutes robot-assisted walking training (RATG), 3 days a week for 4 weeks. Participants will be divided into 3 groups according to the type of stimulation applied by simple randomization. These groups are 1) anodal tDCS + sham ts-DCS; 2) sham tDCS + cathodal ts-DCS 3) sham tDCS + sham ts-DCS. The same evaluations will be applied to all participants during the study and the evaluations are planned as before and after the intervention. The data collected as a result of the evaluations will be analyzed with SPSS version 22.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with MS and suffering from walking difficulties due to MS
* EDSS score between 2-6
* Being over 18 years old

Exclusion Criteria:

* Relapsed within the last two months
* Changed medication within 45 days
* Hospitalized in the last three months
* Had other neurological or musculoskeletal problems
* Had an obstacle to stimulation (skin problems, metal implants, etc.)
* Do not want to participate in the study individuals
A Non-interventional Trial of Erlotinib (Tarceva) Metastatic Non-small Cell Lung Cancer

This is a non-interventional, open label, single arm, multicenter study to assess the safety and efficacy of erlotinib in participants with non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* It is the physician's decision to prescribe erlotinib in participants and to document their treatment
* Participants must be candidates for receiving erlotinib for locally advanced or metastatic non-small cell lung cancer according to the product label

Exclusion Criteria:

* Participants will be excluded if safety concerns occurred
* If the participant was not compliant or if the participant would wish to stop erlotinib therapy
A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants

A Study assessing the drug levels and drug effects of variable doses of BMS-986322 in Healthy Participants compared to a placebo. The study also assesses how BMS-986322 affects the body with food and its acidity levels.

Recruitment temporarily on hold due to COVID-19.

This is a randomized, double-blind, placebo-controlled study which will investigate the safety, tolerability, and PK of single and multiple oral doses of BMS-986322 in healthy subjects. The trial consists of three parts: Part A - a single ascending dose (SAD) safety and pharmacokinetic (PK) evaluation; Part B -a multiple ascending dose (MAD) safety, PK, and pharmacodynamic (PD) evaluation; and Part C - effect of food and pH on PK and safety.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body mass index (BMI) of 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusive, and body weight ≥ 50 kg, at screening
* Women and men must agree to follow methods of contraception.

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of recent infection
* History of allergy to BMS-986322 or other compounds

Other protocol-defined inclusion/exclusion criteria could apply.
The Effectiveness of Applying Art Therapy on Social Interaction, Self-esteem and Well-Being for Elderly Residents in Long-Term Care Institutions

When aging, older people migrate to long-term care institutions. The elderly residents lack autonomy due to the characteristics of group life. The decline of health function or the occurrence of diseases can easily lead to reduced physical activity, decreased interpersonal interaction, social withdrawal, low self-esteem, and decreased well-being. In current that emphasizes the elderly in health promotion and disease prevention activities, art therapy can be applied for the elderly to achieve the purpose of health promotion. Art therapy could effectively improve social interaction, self-esteem, and well-being; but many researchers still suggest that it is necessary to investigate the effectiveness of art therapy for elderly residents in long-term care institutions. The purpose of this study is to explore the effectiveness of art therapy in improving social interaction, self-esteem, and well-being for elderly residents in long-term care institutions.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older and lived in the same long-term care institution for more than three months.
* Communicate in Mandarin or Taiwanese.
* With glasses or hearing aids and other assistive devices can have good vision and hearing functions.
* Both upper limb muscle power ≥ 4 points, can autonomous movement against moderate resistance. Under supervision, can safely use scissors for artistic creation and sit continuously for 90 minutes.
* Score \> 20 points on Barthel Index.
* Score \> 16 points on Mini-Mental Status Examination.
* Score ≤ 9 points on Geriatric Depression Scale.
* After the researcher's explanation, the participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Under 65 years of age, and lived in the same long-term care institution less than three months.
* Severe hearing and vision impaired, making it impossible to communicate.
* Receiving antidepressant drugs or related treatments.
* Completely dependent on activities of daily living.
* Severe depression or severe dementia.
* The elderly are participating in artistic creation-related activities.
A Trial of HRS-7085 Tablet in Healthy Participants With and Without Food Effect.

The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of HRS-7085.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
2. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
3. Total body weight 45 kg\~100 kg (inclusive) at screening, and body mass index (BMI) between 18 and 32 kg/m2 (inclusive).
4. For healthy subjects, no clinically significant abnormalities.
5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods

Exclusion Criteria:

1. Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
2. Severe injuries or major surgeries within 3 months before dosing.
3. Subjects with infectious disease.
4. Live/attenuated vaccine within 3 months prior to dosing or any vaccine during the trial.
5. Blood donation or loss of ≥ 200 mL of blood within 1 month prior to dosing, or ≥ 400 mL of blood within 3 months prior to dosing; or receive a blood transfusion within 2 months prior to dosing.
6. Clinically significant abnormalities in 12-Lead ECG
7. More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening, or positive cotinine test at screening or baseline.
8. Positive urine drug at screening or baseline.
9. Subject who cannot perform venous blood sampling.
10. Known history or suspected of being allergic to the study drugs and their excipients.
11. Use of prescription medicine within 2 weeks, or OTC medicine, within 1-week or 5 half-lives prior to dosing.
12. History of alcohol abuse within 3 months prior to screening, or positive alcohol breath test at screening or baseline.
13. Participation in clinical trials of other investigational drugs or medical devices within 1 month or 5 half-lives prior to dosing.
14. Special dietary requirements that cannot follow the meal plan in the food effect study.
15. In the investigator's judgment, may increase the risk to the subject.
16. Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol.
Effectiveness of Local Application of Warm Air in Patients With Common Cold (HELI Study)

In a randomized controlled trial, the investigators include patients with beginning symptoms of a common cold and compare two interventions:

1. the inhalation of warm air for inducing a warming of the throat and
2. the inhalation of ambient air as control. As outcome the effect on symptoms and duration of the common cold will be assessed. The interventions will consist of visits with a duration of 2-3 minutes on three following days in a Finnish sauna. Patients will be fully dressed.


Eligibility Criteria:
Inclusion Criteria:

* symptom duration between 2 and 24 hours
* at least two of the ten following symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, sore throat, sneezing, and fever
* no usage of medication bought in a pharmacy
* informed consent

Exclusion Criteria:

* fever \>38.5°C
* systolic blood pressure below 100 mmHg or above 160 mmHg
* severe chronic disease, which makes study participation impossible
* pregnancy
Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.

This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 4-6 weeks: the lens prescription of each lens type was optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) wear period.

Eligibility Criteria:
Inclusion Criteria:

1. Were at least 42 years of age and had full legal capacity to volunteer;
2. Had read and signed an information consent letter;
3. Self-reported having had a full eye examination in the previous two years;
4. Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week;
5. Were willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wore spherical multifocal soft contact lenses, for the past 3 months minimum:

   * Maximum of 4 participants (out of 12) per site could be habitual wearers of daily disposable lenses,
   * Maximum of 4 participants (out of 12) per site could be habitual wearers of Biofinity Multifocal,
   * Maximum of 4 participants (out of 12) per site could be habitual wearers of either TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal
7. Had refractive astigmatism no higher than -0.75DC;
8. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
9. Could be fit and achieve binocular distance vision of at least 20/30 Snellen which participants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design).

Exclusion Criteria:

1. Were participating in any concurrent clinical or research study;
2. Had any known active ocular disease and/or infection that contraindicated contact lens wear;
3. Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
4. Were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable;
5. Had known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Had undergone refractive error surgery or intraocular surgery.
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)for the Treatment of Myelodysplastic Syndromes (MDS)

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogeneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

This is a multi-center, open-label, Phase II study of obatoclax administered in 2-week cycles to patients with previously-untreated Myelodysplastic Syndromes with anemia and/or thrombocytopenia. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Myelodysplastic Syndromes are allowed


Eligibility Criteria:
Inclusion Criteria:

* Pathological confirmation of Myelodysplastic Syndromes (MDS)
* Patients must have had no prior systemic therapy
* Must have normal organ functions
* Must have the ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

* Must not be a result of prior chemotherapy and/or radiotherapy for another malignancy
* No other agents or therapies administered in the intent to treat
* Uncontrolled, intercurrent illness
* Pregnant women and women who are breast feeding
Randomized Trial Comparing Lenalidomide With Low Dose Dexamethasone Versus Lenalidomide in Second Line Multiple Myeloma

This is:

* A prospective, randomized, open, phase II, multi-centre, interventional study. Patients who are in at least PR and have received lenalidomide as 2nd line treatment for MM will be recruited.
* The patients will be randomized into two groups. Group R will receive lenalidomide 25 mg/day p.o. continuously for 21 days and group Rb will receive a similar dose of lenalidomide with the addition of 40 mg of dexamethasone p.o. on days 1, 8, 15 and 22 of every 28 day treatment cycle. Study includes a maximum of 24 cycles including two consolidating cycles per patients.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria - all subjects must:

1. Be at least 18 years of age
2. Subjects must have a documented diagnosis of MM and have either refractory or relapsed and refractory after first line treatment disease defined as:

   * Primary refractory
   * Refractory
   * Relapsed and Refractory
3. Subjects must have undergone prior treatment with one treatment line of anti-myeloma therapy. Induction therapy followed by ASCT and consolidation/maintenance will be considered as one line.Have a confirmed diagnosis of MM
4. Have received lenalidomide after one prior treatment for MM and have reached at least a partial response (PR), according to IMWG criteria, including two consolidating cycles. Subjects have experienced a response at least PR after starting treatment with lenalidomide and cortisone cycles.
5. Have personally signed and dated a legally effective written informed consent form prior to admission to the study.
6. Must be willing and able to understand and comply with the study requirements.
7. Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception.
8. Male must agree to practice contraception

Exclusion Criteria:

1. Any of the following laboratory abnormalities:

   * Absolute neutrophil count (ANC) \< 1,000/µL
   * Platelet count \< 75,000/ µL
   * Creatinine Clearance \< 45 mL/min according to Cockcroft-Gault formula
   * Serum SGOT/AST or SGPT/ALT \> 3.0 x upper limit of normal (ULN)
   * Serum total bilirubin \> 2.0 mg/dL
2. ECOG performance status \<4.
3. Individuals who have had a stem-cell transplant as a 2nd line treatment for MM
4. Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening.
5. Individuals with significant psychiatric illness or a clinically significant acute/chronic uncontrolled medical condition that might affect their experience of myeloma symptoms or their ability to describe them.
6. Pregnant or lactating females.
7. Any other clinically significant medical disease or condition that, in the Investigator´s opinion, may interfere with protocol adherence or a subject´s ability to give informed consent.
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab

This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms.

Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at Week 0, Week 4, and then every 12 weeks for 52 Weeks (With the last dose being administered at Week 40). An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A final follow-up phone call will occur at Week 60.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0).
* Participant must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing suboptimal response at time of Screening and Baseline visits.
* Participant must have a Body Surface Area (BSA) 3%- \<10% and Static Physician Global Assessment (sPGA) 2/3
* Participant must be eligible for continued biologic therapy as assessed by the investigator.

Exclusion Criteria:

* History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis, psoriatic arthritis.
* Participant with active skin disease other than plaque psoriasis that could interfere with the assessment of plaque psoriasis.
* History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
* History of major surgery within 12 weeks prior to Baseline or planned to be performed during the conduct of the trial as assessed by the investigator.
* Participant with exposure to risankizumab or any IL-23 inhibitors.
A Phase 2 Study to Evaluate the Safety and Efficacy of CKD-498 in Female Patients With Androgenetic Alopecia

This is a multi-centers, randomized, double-blind, parallel-group, Phase 2 Trial to evaluate the efficacy and safety of CKD-498 in female patients with Androgenetic Alopecia

Participants were randomly assigned in a 1:1:1:1 ratio to the following group: 3 dose of CKD-498 and Placebo. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 24 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* Female of age 19-54 years
* Clinical Diagnosis of Androgenetic Alopecia
* Written informed consent

Key Exclusion Criteria:

* Other types of Alopecia or other diseases that can cause hair loss
* Clinically significant scalp disease such as seborrheic dermatitis or psoriasis
* Clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the Investigator
* Women who are pregnant or breastfeeding
* Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug