cyrilzakka/clinical-trials huggingface dataset:
Examining Behavior Therapy for Trichotillomania in Children and Adolescents

This study will evaluate a treatment for trichotillomania, or compulsive hair pulling, in children and adolescents.

Trichotillomania (TTM) is a chronic impulse control disorder that causes people to pull out their own hair. TTM typically develops in late childhood or early adolescence. It has been suggested that, like with obsessive-compulsive disorder, early identification and treatment of TTM might prevent the disorder and other co-occurring disorders in adults. The researchers in this study have developed the first treatment for TTM to target children and adolescents. Preliminary trials of this treatment, called behavior therapy (BT), indicate efficacy. This study is a larger, more rigorous examination of whether BT can successfully treat children and adolescents with TTM.

Participation in this study will be divided into two phases, each lasting 8 weeks. Follow-up visits will occur 3 and 6 months after completing treatment. In Phase 1, participants will be randomly assigned to receive either BT or supportive counseling (SC) for their TTM. Both groups of participants will complete eight weekly study visits. Those receiving BT will be encouraged to identify situations in which hair pulling is likely to occur and use behavioral techniques to resist urges to pull their hair. BT will also involve self-monitoring and homework throughout the week. Those receiving SC will discuss ways to minimize interference of hair pulling with everyday life and receive education and emotional support from a study therapist-but will not be taught specific behavioral techniques. After 8 weeks, participants will be evaluated to determine whether treatment is helping them. If participants are receiving BT and showing reduction in symptoms, they will continue to Phase 2, which involves four maintenance sessions of BT over 8 weeks. If participants receiving BT are not responding to treatment, they will be given referrals to other services. Participants receiving SC will end their participation after 8 weeks, and those not responding to treatment will be offered BT.

Study assessments will be completed at baseline, after Phase 1, after Phase 2, and at 3- and 6-month follow-ups. These assessments will include a clinical interview, questionnaires about symptoms, and family assessment measures.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis or symptoms of trichotillomania
* Presence of stable parent or guardian

Exclusion Criteria:

* Presence of another primary or co-primary psychiatric disorder that requires initiation of different active current treatment
* Current use of psychotropic medication (participants may be able to stop taking medications to start with study)
Study on Female Patients' Mammographic Texture Features

Mammography is the most common method for breast imaging, and it provides information for model building and analysis. Radiomics applied to mammography has the potential to revolutionize clinical decision-making by providing valuable insights into risk assessment and disease detection. Despite this, the influence of imaging parameters and clinical and biological factors on radiological texture features remains poorly understood. There is a pressing need to overcome the obstacle of system-inherent effects on mammographic images to facilitate the translation of radiological texture features into routine clinical practice by enabling reliable and robust AI-based or AI-aided decision-making. Furthermore, understanding the relationship between imaging parameters, textural features, and clinical and biological information supports the clinical use of AI. The objective of this study is to evaluate AI methods for clinical practice and to study how it relates to clinical factors and biological features.


Eligibility Criteria:
Inclusion Criteria:

* Candidate is a biological female aged 18 years or above;
* Candidate is willing and able to give informed consent and gives their written consent for the participation in the study;
* There is a clinical indication for a uni- or bilateral mastectomy

Exclusion Criteria:

* Candidate lacks the capacity to provide informed consent;
* Candidate has breast implants
Exercise With Blood Flow Restriction in Knee Osteoarthritis

The purpose of this study is to evaluate the neuromuscular responses, pain intensity and rate of perceived exertion in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with blood flow restriction at different levels of arterial occlusion pressure.


Eligibility Criteria:
Inclusion Criteria:

* men and women above 55 years old.
* diagnosed with severe knee osteoarthritis.
* scheduled for unilateral TKA surgery in a local hospital during 2021- 2022.

Exclusion Criteria:

* pain in the contralateral limb (maximum pain, ≥80 of 100 mm on a VAS during daily activities).
* another hip or knee joint replacement in the previous year.
* any medical condition in which exercise was contraindicated.
* participated in exercise programs (\>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study.
* history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of dual tasks.
Metformin in Pregnant PCOS Women

To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years,
* PCOS diagnosis according to Rotterdam criteria
* single, viable, ultrasound verified fetus
* if metformin was used at conception and early pregnancy, at least 7 days of "wash out"

Exclusion Criteria:

* known liver disease or ALAT \> 90 nmol/L
* known renal disease or creatinine \> 110 micromol/L
* diabetes mellitus
* alcohol or drug abuse
* peroral steroid treatment
* cimetidine, anticoagulant or erythromycin treatment at time of inclusion
* not suitable for other reasons
Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee

This study is to validate the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) tool in mainland Chinese patients with osteoarthritis of the knee . This study will also evaluate the effects of Mobic versus placebo on reducing the symptoms of osteoarthritis in this population.

To validate culturally the WOMAC tool in mainland China and observe the different response of meloxicam and placebo in a patient population with osteoarthritis of the knee

Eligibility Criteria:
Inclusion Criteria:

Subjects are required to meet the following criteria to be eligible for Randomization into this study:

* Male or female Chinese subjects, 18-75 years of age;
* Subjects must have a diagnosis of OA of the index knee based on American College of Rheumatology criteria with X ray confirmation (a Kellgren Lawrence x ray grade of greater than or equal to 2) (Kellgren J. \& Lawrence J, 1957)
* Subjects must have have an NRS and a WOMAC pain sub scale score of 4 at Screening and at Baseline based on four daily diary entries

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

* History of other disease that may involve the index (painful) knee including inflammatory joint diseases or have had recent surgical intervention on the knee.
* Diagnosed as having or has been treated for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication. History of or active gastrointestinal disease (eg, inflammatory bowel disease), a chronic or acute renal or hepatic disorder, or a significant coagulation defect.
* Signs and symptoms of clinically significant cardiac disease
Long-Term Treatment With rhIGF-1 in GHIS

The objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe Primary insulin-like growth factor-1 deficiency (Primary IGFD).


Eligibility Criteria:
Inclusion Criteria:

* Height \<-2SD for age and gender
* IGF-1 \<-2SD for age and gender
* Evidence of GH resistance

Exclusion Criteria:

* closed epiphyses
* prior active malignancy
* major organ disfunction
* treatment with medications that would diminish growth
* clinically significant cardiac abnormalities
The Effect of Concentrated Pomegranate Juice Consumption on Lipid Profile and Inflammatory Factors in Patients With Type 2 Diabetes

The aim of this study is to examine the effects of concentrated pomegranate juice on serum lipid profile and some inflammatory factors in patients with type 2 diabetes. Forty patients aged between 25-60 years old from both sexes are recruited. Patients consume 50gr/day concentrated pomegranate juice for 4 weeks. Anthropometric and blood pressure measurements, 3-days food-record questionnaire ,physical activity and fasting blood samples were collected at the beginning and at the end of the study. Fasting blood sugar, lipid profile, TNF- a, IL-6,hs -CRP and adiponectin levels are measured. LDL are calculated by formula. The participants are asked not to change their regular diet, medicine and activity during the study.


Eligibility Criteria:
Inclusion Criteria:

* male or female 25 to 60 years old
* having type 2 diabetes for at least 6 month

Exclusion Criteria:

* pregnancy
* lactation
* cardiac disease
* hepatic disease
* respiratory disease
* chronic renal diseases
* acute or chronic inflammation
* retinopathy
* intake of antioxidant supplement
* insulin therapy
* sensitivity to concentrated pomegranate juice
* change oral drug for controlling blood glucose
Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain

This study will evaluate the efficacy and safety of a single intra-articular (IA) injection of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee pain.


Eligibility Criteria:
Inclusion Criteria:

* Painful osteoarthritis in the study knee
* Able to walk without assistive walking devices, able to perform usual daily activities, and agree to maintain similar activity level throughout the study

Exclusion Criteria:

* Chronic pain conditions other than knee osteoarthritis
* Presence of bursitis, meniscus tear, ligament tear, or significant injury to the study knee within 1 year
* Surgery to the study knee within 24 weeks
* Treatment with hyaluronic acid in the study knee within 24 weeks
* Treatment with corticosteroids in the study knee within 12 weeks
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
* Previous treatment with botulinum toxin of any serotype for any reason
The Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With PFNA

Phase III, prospective, randomized, parallel, double blind, placebo-controlled study to determine whether Teriparatide can accelerate bone healing in unstable intertrochanteric fracture patients treated with Proximal Femoral Nail Antirotation (PFNA) assessed by radiographic and clinical outcomes.

Patients will undergo screening assessment to determine the eligibility for study participation and will be randomized in 1:1 ratio to receive Teriparatide 20 μg or placebo subcutaneous once daily for 12 weeks.

All patients will receive supplements of 1000 mg/day of elemental calcium and 20,000 IU/week of vitamin D2.

Patients will be scheduled to clinic visit for radiographic and clinical assessment at 2, 6,12 and 24 weeks postoperatively. Each participant will be in the study for 6 months in total.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patient, age ≥ 50 years at the time of screening
2. Unstable intertrochanteric fracture (AO/OTA 31-A2 and 31-A3)
3. Treated by proximal femoral nail antirotation (PFNA)

Exclusion Criteria:

1. Known hypersentivity to teriparatide or any form of PTH or analogue
2. Metabolic bone disease other than primary osteoporosis (including Hyper Parathyroidism and Paget's disease of bone)
3. Increased baseline risk of osteosarcoma (Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation)
4. History of malignant neoplasm in the 5 years prior to the study (with the exception of superficial basal cell carcinoma or squamous cell carcinoma) and carcinoma in situ of the uterine cervix treated less than 1 year prior to the study.
5. Pre-existing of hypercalcemia (total serum calcium \>10.5 mg/dL or 2.6 mmol/L)
6. Abnormally elevated serum intact parathyroid hormone at screening (serum PTH \> 70 pg/mL)
7. Severe vitamin D deficiency (25-hydroxyvitamin D \< 12 ng/mL)
8. Unexplained elevations of alkaline phosphatase (ALP \> 120 UL)
9. Severe renal impairment (CrCL \< 30 mL/min)
10. Current treatment with digoxin and necessary to continue use during the study
11. Concurrent treatment with oral bisphosphonates, selective estrogen receptor modulator (SERMs), calcitonin, estrogen (oral, transdermal, or injection), progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and active vitamin D3 analogs. (Previous treatment is allowed but must be discontinued at screening)
12. Previous treatment with strontium ranelate for any duration, intravenous bisphophonates within 12 months prior to the screening date, and/or denosumab within 6 months prior to the screening.
13. Previous treatment with teriparatide, PTH or other PTH analogs, or prior participation in any other clinical trial studying teriparatide, PTH or other PTH analogs
Effects of Sodium-glucose Co-transporter-2( SGLT-2 ) Inhibition on Sympathetic Nervous System Activity in Humans

This study is designed to investigate whether the sodium-glucose co-transporter-2 (SGLT-2) inhibitor Empagliflozin reduces sympathetic nervous system (SNS) activity in humans.

This is a randomised, double-blind, placebo controlled, cross-over study. Participants will be randomly assigned to receive either Empagliflozin 10mg/daily or Placebo and will later receive the alternate treatment.

Comprehensive testing will occur after each 4 week treatment phase and will include assessment of muscle sympathetic nerve activity, cardiac and renal noradrenaline spillover to assess organ specific SNS activity.

Eligibility Criteria:
Inclusion Criteria:

* Age: 25 -65 years
* (Body Mass Index) BMI≥30kg/m2
* Currently weight stable (+/- 3% in previous 6-12 months and not on any specific exercise or dietary program)
* Metabolic syndrome (defined as having: obesity (BMI ≥30kg/m2 ) plus any two of the following four factors: Elevated triglycerides (Triglyceride≥ 1.7mmol/L), Reduced HDL (High - density lipoprotein) cholesterol (\<1.0mmol/L in males, \<1.3mmol/L in females), Elevated clinic systolic (Blood Pressure) BP ≥130 or diastolic BP ≥85mmHg, Fasting glucose ≥5.6mmol/L or type 2 diabetes.
* office BP for screening purposes ≤160/90mmHg
* drug naïve for at least 6 weeks prior to baseline assessment

Exclusion Criteria:

* Grade 2-3 hypertension (systolic office BP \>160, diastolic office BP \>100 mmHg)
* Secondary causes of hypertension
* CKD (Chronic kidney disease) stage 4-5 {(estimated glomerular filtration) eGFR\<30ml/min}
* Heart failure NYHA (New York Heart Association) class II-IV
* Recent CV (cardiovascular) event (acute myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous six months)
* unstable psychiatric condition
* medication such as corticosteroids, several antidepressants and antipsychotics
* Female participants of childbearing potential must have a negative pregnancy test prior to treatment
Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis

A randomized placebo-controlled clinical trial to evaluate efficacy of hyaluronic acid in prevention of acute radiation proctitis among oncology patient population especially who are diagnosed with abdomeno-pelvic tumors and subsequently required radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with pelvic or gastrointestinal malignancies (tumors in uterus, cervix, prostate, seminal vesicles, kidney, colon, etc.),
* All patients who required adjuvant or radical radiation therapy;
* Age \&lt; 80 years;
* Karnofsky Performance Status ≥ 60

Exclusion Criteria:

* Patients were excluded if they had

  * gt; previous pelvic radiotherapy,
  * gt; inflammatory bowel disease or
  * gt; rectal issues (e.g., haemorrhoids).
* Patients diagnosed with cancer rectum
An Efficacy and Safety Study of Escitalopram Long-Term Treatment in Major Depressive Disorder With Associated Anxiety Symptoms

The purpose of this study is to evaluate the efficacy and safety of long term escitalopram treatment in participants with Major Depressive Disorder (MDD) with associated anxiety symptoms.

This is an open-label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time), post-marketing, multi-center (when more than one hospital or medical school team work on a medical research study) study to evaluate the efficacy and safety of escitalopram in participants with MDD with associated anxiety symptoms. The duration of the study will be 24 weeks at a starting dose of escitalopram 10 milligram per day (mg/day). The dose will be flexibly adjusted (maximum 20 mg/day) after 2 weeks of treatment depending on Investigator's discretion. The study will consist of 9 visits: Baseline, Week 1, 2, 4, 8, 12, 16, 20 and 24. Assessments of efficacy and safety will be performed at each visit. The primary efficacy evaluation will be done by Montgomery-Asbery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale(HAM-A). Participant's safety will also be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be willing and able to give written informed consent
* Participant currently suffering from Major Depressive Disorder (MDD) with anxious symptoms including participant with first MDD episode, and relapsed participant with new episode
* Participant with minimum score at baseline of 22 on the Montgomery-Asbery Depression Rating Scale (MADRS) and minimum score at baseline of 14 on Hamilton Anxiety Rating (HAM-A) scales
* Female participant must be surgically sterile, or practicing an effective method of birth control before entry and throughout the study

Exclusion Criteria:

Participant who has continuously taken psychoactive substances, antidepressants, anxiolytics, monoamine oxidase inhibitors (MAOIs), psychoactive herbal remedies, lithium, electroconvulsive therapy (ECT) carbamazepine in the past 2 weeks before the baseline visit - Participants with MDD, requiring treatment systematically within past 2 months from baseline - Participants who has contraindication to escitalopram - Participant has primary or comorbid diagnoses of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations \[imagining things\], and withdrawal into the self), schizoaffective disorder (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder), bipolar disorder, or dementia (mental decline) - Participant who has a significant risk of suicide on clinical assessment or has made a serious suicide attempt within the past 6-month
Inspiratory Muscle Training in Hypercapnic COPD

The trial intends to investigate, whether inspiratory muscle training in hypercapnic patients improves inspiratory muscle strength, inspiratory muscle endurance and endurance to walk within six minutes.

Inspiratory muscle training is known to improve inspiratory muscle strength, inspiratory muscle endurance and walking distance within six minutes in patients with neuromuscular and thoraco-restrictive disease as well as in patients with COPD. Studies have only been conducted in patients without established respiratory failure. COPD patients with respiratory failure though are characterized by higher work rates of the inspiratory muscles and higher esophageal pressure swings compared to non-hypercapnic patients indication a discrepancy between muscle load and muscle capabilities. Therefore we hypothesize that for these patients training of their inspiratory muscles will be of benefit in terms of improvement of muscular and whole body endurance.

During this investigation inspiratory muscle training will be applied in a randomized controlled fashion in 40 patients over a period of four weeks parallel to physical rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* COPD with FEV1/FVC \< 70 %
* age \> 18
* stable disease
* able to walk
* carbon dioxide \>= 48 mmHg

Exclusion Criteria:

* ejection fraction of the heart \< 40 %
* active psychiatric disease
* bronchial hyperresponsiveness according to ATS criteria
* pregnancy
* renal insufficiency with a creatinine \< 2 mg/dl
Visual Perceptual Learning for the Treatment of Visual Field Defect

This study evaluates the efficacy of visual perceptual learning for the treatment of visual field defect caused by brain damage. Half of participants will receive visual perceptual training using the Nunap Vision, while the other half will receive sham training using the Nunap Vision-C.


Eligibility Criteria:
Inclusion Criteria:

* Age 19-80 years
* Brain damage-induced visual field defect
* At least 6 months after brain lesion
* Minimum of 4 testing locations, where measured threshold ≤ 20dB
* Verified visual pathway damage using CT or MRI
* K-MMSE(Korean Mini Mental Status Examination) score ≥ 24
* Visual acuity equal or better than 20/40
* Able to use the investigational device
* Patient/legally authorized representative has signed the informed consent form

Exclusion Criteria:

* Unreliable Humphrey visual field test (any of fixation loss, false positive, false negative ≥ 20%)
* Complete hemianopsia with sensitivity of the whole hemifield ≤ 3 dB
* Epilepsy, photosensitivity, Parkinson's disease
* Bilateral visual field defect
* Hemispatial neglect
* Ophthalmologic disorder that may interfere the trial
* Inability to discontinue psychostimulants such as methylphenidate, modafinil, and amphetamine.
* Candidate for carotid endarterectomy or stenting
* Received ophthalmologic surgery within 3 months, except for the cataract surgery
* Pregnant or breast feeding
* Participating in other clinical trial
* Any other condition that, in the opinion of the investigator, precludes participation in the trial