cyrilzakka/clinical-trials huggingface dataset:
Cross-sex Hormone Therapy and Neuronal Plasticity

Transgender women (male-to-female) were invited to participate in this study to test the impact of Cross-Sex Hormone Therapy (CSHT) in the brain.

Neuroimaging and cognitive assessment were performed in different time-points to compare the impact of CSHT in the brain.

Sex hormones are known to exert several effect on the brain white matter, cerebral cortex, functional connectivity and neurotransmission. Furthermore, in transgender people, CSHT is know to induce anatomical and functional changes in the brain. However, only a few studies have already been conducted to investigate the effects of sex hormones on the brain accounting for the interference of endogenous gonadal hormones. Also, there is a lack of knowledge about the importance of CSHT after Gender Affirming Surgery (GAS) regarding induced hypogonadism that follows this surgical procedure. Therefore, neuroimaging studies designed to isolate the effect of endogenous gonadal hormones in people with GD urge to be developed.

To fulfil this purpose, transgender women that have already performed GAS and/or were under Gonadotrophin Release Hormone analogues treatment (in order to induce hypogonadism similar to GAS) were invited to interrupt CSHT for at least 30 days to promote sex hormones washout. At the end of the washout, participants performed magnetic resonance imaging, laboratorial analyses for sex hormones and neuro-cognitive assessment. After this first time-point, participants received a new prescription for CSHT containing estradiol (without progesterone) to be used continuously for 60 days, when the same assessments from the end of washout were repeated 60 days after CSHT to compare brain and cognitive longitudinal changes.

At all the time-points, variations in depression scores and anxiety levels were assessed with specific scales.

Eligibility Criteria:
Inclusion Criteria:

* Transgender women
* Age 18 to 60 years old.

Exclusion Criteria:

* Use of psychostimulant drugs
* Use of Antidepressive, Mood Stabiliser, Anti-psychotic, Benzodiazepines, anti-convulsivants, Anorexigenic
* Endocrinological disease (other than diabetes)
* Arterial Hypertensive Disease of Diabetes Mellitus out of control target
* Neurological disease, including stroke or recent cranial trauma with loss or consciousness
* HIV with low CD4 or high viral charge or symptomatic AIDS
* Neoplasia
A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)

The purpose of this study is to determine if analgesic efficacy can be detected with single dose administration in patients with chronic neuropathic pain due to painful diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been treated for type 1 or 2 diabetes mellitus with glycosylated hemoglobin
* Patient has pain in both feet that occurred after onset of diabetes
* Patient agrees to maintain a consistent activity level throughout the study
* Patient is not on chronic pain therapy, or is on a stable dose of one pain therapy
* Female patients of reproductive potential must agree to use two acceptable methods of birth control through out the study
* Patients taking a pain medication must be on a stable dose at least 1 month prior to participating in study

Exclusion Criteria:

* Patient has a history of congestive heart failure
* Patient has/had a seizure disorder
* Patient has tried and failed 3 or more drugs to treat neuropathic pain
* Patient is currently taking pregabalin or duloxetine hydrochloride
* Patient has had a malignancy within the past 2 years (excluding basal cell carcinoma)
* Patient has history of hepatitis B or C or HIV infection
* Patient has skin-condition that may decrease sensitivity in area of neuropathic pain
A Drug-Drug Interaction Study of Losartan and PA21

The purpose of this study is to determine if Losartan potassium is affected by PA21.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Written informed consent

Exclusion Criteria:

* No significant medical conditions
* Pregnancy
Laser Therapy in Adhesive Capsulitis

Adhesive capsulitis is an idiopathic disease characterized by a decrease in the volume of the glenoid capsule, the development of fibrosis and a progressive decrease in the range of joint movement with pain. Shoulder pain and stiffness are accompanied by disability. The purpose of the study is to evaluate and compare the effects of high-intensity laser therapy on pain, disease - related disability and quality of life in patients with shoulder restriction and pain due to adhesive capsulitis.

Adhesive capsulitis is an idiopathic disease characterized by a decrease in the volume of the glenoid capsule, the development of fibrosis and a progressive decrease in the range of joint movement with pain. Shoulder pain and stiffness are accompanied by disability. It is thought that the incidence is 3% to 5% in the general population and 20% in people with diabetes. Although usually reported to be self-limiting in 2 to 3 years, studies have reported that 40% of patients have persistent pain and stiffness for more than 3 years.

Therefore, various therapies are used to reduce pain and increase the range of motion more rapidly without waiting for spontaneous recovery. Adhesive capsulitis treatment includes conservative and surgical treatment options. The options for non-surgical treatments are pharmacological treatments including intra-articular injection and physical therapy modalities. As for physical therapy modalities, various interventions are used. These include heat or ice, therapeutic ultrasound, transcutaneous electrical nerve stimulation and laser therapies.

The aim of exercise programs consisting of joint range of motion (ROM), strengthening and stretching exercises, proprioceptive neuromuscular facilitation and mobilization techniques is to alleviate pain caused by the capsular contracture and to improve glenohumeral ROM.

The purpose of the study is to evaluate and compare the effects of high-intensity laser therapy on pain, disease - related disability and quality of life in patients with shoulder restriction and pain due to adhesive capsulitis.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with adhesive capsulitis diagnosis by physical examination (Compared with intact side, there is more than 25% limitation in at least two directions of shoulder range of motion)
* Subjects have complaints for at least 1 month
* No pregnancy / breastfeeding

Exclusion Criteria:

* History of bilateral adhesive capsulitis
* History of shoulder trauma, fracture, shoulder shoulder surgery, calcific tendinopathy, glenohumeral osteoarthritis, inflammatory rheumatic diseases, tumor, infection
* History of corticosteroid injection in the shoulder during the last 3 months
* History of recent lung, breast or bypass surgery
* History of cervical radiculopathy / brachial plexus lesion
* History of neuromuscular disease
* History of physical therapy program for the same shoulder in the last 6 months
The Effect of Volatile Anesthesia and Total Intravenous Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Mastectomy and Breast Reconstruction Using Deep Inferior Epigastric Artery Perforator Free Flap

The aim of this study was to investigate the effects of total intravenous and inhalation anesthesia on the damage of endothelial glucocorticoids by comparing the concentration of syndecan-1 in patients undergoing mastectomy and breast reconstruction using deep inferior epigastric artery perforator free flap

The aim of this study was to investigate the effects of total intravenous and inhalation anesthesia on the damage of endothelial glucocorticoids by comparing the concentration of syndecan-1 in patients undergoing mastectomy and breast reconstruction using deep inferior epigastric artery perforator free flap

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients over 20 years old with ASA class I-III
2. Scheduled total mastectomy and deep inferior epigastric artery perforator flap breast reconstruction

Exclusion Criteria:

1. emergency surgery
2. Bilateral deep inferior epigastric artery perforator flap breast reconstruction
3. patients unable to make their own decisions, illiterate, foreigners
4. Allergy / hypersensitivity to sevoflurane or propofol 5, Current or past history or thrombosis / thromboembolism

6. patients who are taking oral contraceptives 7. Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less) 8. Patients receiving anticoagulants 9. pregnant and lactating women 10. Patients with history of psychiatric disease or neurological disease
Medical Yoga for Patients With Stress-related Symptoms and Diagnoses

Background An increasing number of patients are suffering from stress-related symptoms and diseases. No scientific studies have examined the effects of Medical yoga on stress-related symptoms in patients in primary care. The purpose of this study was to evaluate Medical yoga treatment in patients with stress-related symptoms and diagnosis in primary health care.

Methods A randomized, controlled study was performed at a primary health care centre in Sweden from March to June 2011. Patients were randomly allocated to a control group receiving standard care, or a yoga group treated with Medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age 53±12 years, seeking care for stress-related symptoms at the primary health care centre were included and followed up after the 12-week study period. General stress level (measured using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)) and overall health status (Euro Quality of Life-VAS (EQ-VAS)) were measured before and after 12 weeks.

Main outcome:

The Perceived Stress Scale is a 10-item self report questionnaire that measures persons' evaluation of the stressfulness of the situations in the past month of their lives. The citation for the 10-item scale is Cohen, S., \& Williamson, G. (1988). Perceived stress in a probability sample of the United States. In S. Spacapan \& S. Oskamp (Eds.). The Perceived Stress Scale is the only empirically established index of general stress appraisal. "The PSS measures the degree to which situations in one's life are appraised as stressful" (Cohen, et al., 1983; p. 385).

PSS-10 scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. Scores can range from 0 to 40, with higher scores indicating greater stress.

The PSS is not a diagnostic instrument, so there are no cut-offs. There are only comparisons between people in a given sample. There are some normative data on the PSS based on a 1983 Harris Poll of a representative U.S. sample. These data may be helpful in providing comparisons, but they are over 20 years old. See: Cohen, S., \& Williamson, G. (1988).

Eligibility Criteria:
Inclusion Criteria:

* The patients had sought treatment at the primary health centre during the previous 6 months.
* The stress-related symptoms included fatigue, insomnia, anxiety, depression, hypertension, and musculoskeletal discomfort in the neck and shoulders.

Exclusion Criteria:

* Inability to understand instructions, interpretation needs or physical or mental inability to carry out the Medical yoga exercises, such as mental retardation or dementia, and severe physical or mental illness.
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

This study will compare DS 8201a to standard treatment.

Participants must have HER2 breast cancer that has been treated before.

Their cancer:

* cannot be removed by an operation
* has spread to other parts of the body

The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.

Eligibility Criteria:
Inclusion Criteria:

* Is the age of majority in their country
* Has pathologically documented breast cancer that:

  1. is unresectable or metastatic
  2. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
  3. was previously treated with ado-trastuzumab emtansine (T-DM1)
* Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
* Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
* Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least:

  1. 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
  2. 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
  3. 7 months after the last dose of trastuzumab/capecitabine
* Has adequate hematopoietic, renal and hepatic functions

Exclusion Criteria:

* Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy
* Has had prior treatment with capecitabine
* Has uncontrolled or significant cardiovascular disease
* Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
* Has active central nervous system (CNS) metastases
Functional Pathologies of the Musculoskeletal System in Physiotherapy Students

This study map the occurrence of functional pathologies of the musculoskeletal system in students of the bachelor's program of physiotherapy of the Third Faculty of Medicine, Charles University, and aim on improvement of them.

The aim of this study is to map the occurrence of functional pathologies of the musculoskeletal system in students of the bachelor's program of physiotherapy of the Third Faculty of Medicine, Charles University, and to examine their postural functions. Another goal is to teach the students of the experimental group how to remove functional pathologies of the musculoskeletal system and how to change their motor behaviour and postural functions so that the development of functional disorders no longer occurs.

Eligibility Criteria:
Inclusion Criteria:

* Bachelor's study of physiotherapy at the Third Faculty of Medicine, Charles University
* The presence of functional pathologies of the musculoskeletal system (verification by means of Trigger Points)

Exclusion Criteria:

* Serious cardiovascular or orthopedic dysfunction
* Neurological disease
* Reduced cognitive functions complicating examination and subsequent therapy
CAN BREATHE in COPD Trial

A growing body of physiological evidence now exists to support a potential role for inhaled cannabis in the medical management of adults with chronic obstructive pulmonary disease (COPD), particularly as it may related to improving pulmonary function, alleviating the symptom of breathlessness and improving exercise endurance. The purpose of this randomized double-blind crossover trials is to evaluate the efficacy and physiological mechanism(s) of action of inhaled vaporized cannabis targeted to relief of physical activity-related breathlessness and exercise endurance in symptomatic patients with severe-to-very severe COPD.


Eligibility Criteria:
Inclusion Criteria:

* GOLD stage III or IV COPD (i.e., post-β2-agonist FEV1 of 50% predicted or less)
* Self-reported cigarette smoking history ≥10 pack yrs
* Currently taking long-acting beta-2 agonists and long-acting antimuscarinic agents (LABA/LAMAs) with or without an inhaled corticosteroid
* Willing to abstain from cannabis smoking for ≥15 days prior to study participation (if applicable)
* Willing to abstain from non-study related cannabis smoking throughout the study period (if applicable)
* No change in medication dosage or frequency of administration, with no exacerbations or hospitalizations in the preceding 4 weeks

Exclusion Criteria:

* Presence of active and/or uncontrolled cardiopulmonary and/or musculoskeletal disease other than COPD that could contribute to breathlessness and exercise intolerance
* Hepatic or renal impairment
* Psychiatric history (other than depression and/or anxiety)
* History of epilepsy or convulsions;
* Lung cancer
* History of sensitivity to cannabis
* Use of levodopa, sildenafil and/or fentanyl
* Use of ketoconazole
* Use of regular high dose opioids (i.e., 30 mg of oral morphine equivalents/day)
* Known or suspected history of addiction/substance abuse based on CAGE-AID and SISAP scores (\*note, patients may be recruited if they have a history of smoking cannabis)
* Positive urine toxicology for cannabinoids on screening
* Positive pregnancy urine test
* Subject cannot arrange to be accompanied home by a family member and/or friend during each treatment visit.
Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation

The aim of the present study is to investigate the possibilities of visual field enhancement with electrical stimulation (ES) as a home stimulation method, in a total of 50 patients with optical neuropathy, who have already been treated with ES in the past.

Furthermore, factors responsible for response variability and treatment effectiveness are also explored: (i) the role of mental stress (or stress resilience), (ii) the status of biomarkers, such as the systemic stress hormone levels and blood supply to the eye and brain (specifically vascular dysregulation) and (iii) the influence of personality, anxiety, depression and lifestyle. The study serves to further validate this ES procedure for the treatment of visual impairment. Specifically, better efficacy, better compliance, lowest response variability are expected after long-term home use.


Eligibility Criteria:
Inclusion Criteria:

* Patients with glaucoma, disease duration at least 6 months
* stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)
* presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician
* best corrected visual acuity at least 0.4 (20/50 Snellen) or better

Exclusion Criteria:

* autoimmune diseases in the acute stage
* neurological and mental diseases
* diabetic retinopathy
* addictions
* hypertension (maximum 160/100 mmHg)
* retinitis pigmentosa-
* pathological nystagmus
* non-distant tumors or recurrent tumors
* photosensitivity
* pregnancy
* electric or electronic implants (e.g. heart pacemaker)
* metal implants in the eyes or head (with the exception of dental prosthesis or shunts)
AltaValve Pivotal Trial

This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Symptomatic New York Heart Association (NYHA) class II-IV.
* Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
* Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.

Exclusion Criteria (Abbreviated List):

* Inability to understand the trial or a history of non-compliance with medical advice.
* Inability to provide signed Informed Consent Form (ICF).
* History of any cognitive or mental health status that would interfere with participation in the trial.
* Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).
* Female subjects who are pregnant or planning to become pregnant within the trial period.
* Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.
* Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
* Known hypersensitivity to contrast media that cannot be adequately medicated.
* Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.
* Concurrent medical condition with a life expectancy of less than 12 months.
* Transcatheter aortic repair or replacement within 90 days prior to the index procedure.
* Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.
A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin

The purpose of this study is to compare the efficacy (in terms of weight and hemoglobin type A1c \[HbA1c\]) and safety of topiramate (96 milligrams\[mg\] or 192 mg daily) with placebo in the treatment of obesity in Type 2 diabetic patients receiving metformin.

Topiramate is not approved for the treatment of obesity. This double-blind, placebo-controlled study is designed to assess the efficacy and safety of topiramate in Type 2 diabetic patients with obesity who are well-controlled on metformin alone. Patients are randomized to receive either topiramate (up to a target dose of 96 or 192 mg per day) or placebo for one year. Assessments of efficacy include weight reduction, levels of HbA1c (shows average blood sugar level over a few months), Body Mass Index (BMI), and Health Related Quality of Life (HRQOL) measures. Safety evaluations (incidence of adverse events, vital signs, hypoglycemic events, electrocardiograms \[ECGs\], clinical laboratory values) are monitored throughout the study. The study hypothesis is that topiramate, combined with metformin and non-pharmacologic therapy, can effectively achieve significant weight reduction and is well tolerated. During the first 8 weeks, oral doses of matching placebo or topiramate are increased gradually to target dose (96 milligrams\[mg\] or 192mg daily); the dose will be maintained for 1 year, then gradually reduced and stopped

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 diabetes and receiving metformin monotherapy for at least the previous 4 months and on a stable daily dose for at least 2 months prior to enrollment
* Metformin total daily dose not to exceed 2.1 grams/day
* Body Mass Index \>= 27 and \< 50
* HbA1c \< 11%
* Fasting plasma glucose \>= 126 and \< 240
* Stable weight
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

* Known contraindication, or hypersensitivity to topiramate
* Use of other antidiabetic medications within the last 4 months
* Excessive weight loss
* Diagnosis of type 1 diabetes
* History of severe or recurrent hypoglycemic episodes
* Severe pulmonary disease