cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Biofeedback in the Treatment of Tic Disorder

To investigate the efficacy of EEG biofeedback and drug therapy in the treatment of tic disorders

This study intends to investigate the efficacy of EEG biofeedback and drug therapy on clinical symptoms, cognitive flexibility and quality of life in chronic tic disorder and Tourette syndrome through a randomized controlled study.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders(Fifth Edition,DSM-5) for chronic tic disorder or Tourette syndrome（TS）;
* Ethnic group is Han nationality;
* Aged 8 \~ 16 years old;
* otal IQ of Wechsler Intelligence Scale for Children ≥ 80 points for subjects;
* Symptom severity score in Yale Global Severity Scale (YGTSS), TS patients \> 13, CTD \> 9;
* Did not receive any drug (including traditional Chinese medicine) treatment 4 weeks before enrollment;
* Obtain written informed consent from children and guardians

Exclusion Criteria:

* Epilepsy, cardiovascular disease
* Patients with schizophrenia, mental retardation, autism spectrum disorder, bipolar disorder and major depression who meet the DSM-5 diagnostic criteria;
* Receiving systematic traditional Chinese medicine treatment one month before enrollment or currently;
* Receiving systematic psychotherapy one month before enrollment or currently;
* Receive systematic physical therapy one month before enrollment or currently
* Those who cannot follow the doctor's advice or refuse to cooperate;
* Those with obvious abnormal laboratory test results (AST or ALT ≥ 2 times of the upper limit of normal value; bun ≥ 1.5 times of the upper limit of normal value; Cr ≥ 1.2 times of the upper limit of normal value);
* Prolongation of QTc interval (QTc ≥ 450 ms in men or ≥ 470 MS in women);
Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination

The aim of the study to evaluate the possible effect of washing the insemination catheters before intrauterine insemination on the pregnancy outcomes.

We know that washing the catheters are already washed in the case of embryo transfer for assisted reproductive techniques. Based on this knowledge, we also constituted the hypothesis which is about the impact of washing the catheter on the gametes and embryos. The pre-washing the catheter before intrauterine insemination may provide higher pregnancy results.


Eligibility Criteria:
Inclusion Criteria:

* at least 1-year infertility
* at least one patent fallopian tube confirmed by hysterosalpingography (HSG) or laparoscopy
* ovulatory menstrual cycles
* suitable semen analysis according to the World Health Organization (WHO) criteria for intrauterine insemination

Exclusion Criteria:

* bilateral tubal occlusion
* mild or severe endometriosis
* day 3 serum FSH (follicle-stimulating hormone) \> 13 IU/L
* abnormal thyroid function tests, hyperprolactinemia
* total motile sperm count (TMSC) \< 5 millions or severe teratospermia (\<4% normal forms) following semen preparation
* more than 3 follicles above the size of 17mm on the day of ovulation triggering
A Long-term Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in dry eye patients with Sjögren's syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Dry eye patients with Sjögren's syndrome
* Corneal and conjunctival damage

Exclusion Criteria:

* Severe ophthalmic disorder
* Punctal plugs or surgery for occlusion of the lacrimal puncta
Development of an Imaging Prediction Model for Pelvic Lymph Node Metastasis of Cervical Cancer Using Artificial Intelligence Techniques.

This study is a retrospective exploratory trial conducted at a single center, aiming to develop and validate a preoperative lymphatic metastasis model for cervical cancer using artificial intelligence deep learning. The model is trained using preoperative imaging and postoperative pathological findings of cervical cancer patients, with the goal of enhancing the accuracy of lymphatic metastasis prediction through preoperative imaging and offering insights for treatment decisions.


Eligibility Criteria:
Inclusion criteria:

1. patients with preoperative diagnosis of invasive cervical cancer stage I-III, with any type of pathology, and patients who underwent radical/modified radical cervical cancer surgery + pelvic lymph node dissection in our hospital.
2. Age ≥18 years old and ≤80 years old
3. patients with complete preoperative pelvic MRI images and postoperative pathology and clinical data in our hospital

Exclusion criteria:

1. Patients during pregnancy or breastfeeding, patients within 42 days of abortion
2. Patients who have received neoadjuvant chemotherapy or radiotherapy before surgery for this previous cervical cancer
3. Patients with other malignant tumors within 5 years
4. Combination of other underlying diseases that may lead to enlarged pelvic lymph nodes
5. Imaging report more than 1 month prior to surgery
6. Poor image quality and unrecognizable
Glucose and Blood Pressure During Pregnancy

The purpose of this research is to examine the beneficial effects of regular, non-invasive, glucose (sugar) assessment on glucose (sugar) and blood pressure regulation during pregnancy to help in predicting gestational diabetes and preeclampsia.

This is an open-label pilot trial for the LabClasp combined with standard clinical care compared to standard clinical on \[glucose\] and blood pressure during pregnancy. Potential study participants will be pre-screened using questionnaires and review of their clinical records. Once the consent has been obtained, participants will undergo screening to confirm eligibility. Subjects who meet all criteria will be randomized to either LC+SC or SC cohorts for 24-39wks depending upon their gestational duration at enrollment. Study measures including anthropometrics, surveys/questionnaires, 24hr ABPM, accelerometry, and an oral glucose tolerance test (OGTT). Furthermore, the investigators will obtain repeated (annual) subject information including vitals, labs, medications, and development of cardiometabolic disorders for up to 10yrs in follow-up by reviewing Mayo Clinic medical records.

Eligibility Criteria:
Inclusion Criteria:

* Age range: 18-45 years (inclusive)
* Body mass index (BMI) ≤40kg/m2
* \>1 risk factor for GDM
* \<16wks gestation
* Gender: only females will be recruited into this study
* Ability to provide written informed consent

Exclusion Criteria:

* Presence of chronic kidney disease (creatinine \>2.5mg/dL) and/or active cancer
* Smoking
* Multiple pregnancies
* Congenital abnormalities
* Use of chronic medications which influence blood \[glucose\] or \[insulin\]
* Subsequent diagnosis of GDM or preeclampsia
Depth of Necrosis in Normal Cervical Epithelium After 85% Trichloroacetic Acid (TCA) Application

Early detection and treatment of precancerous lesions are the pillars of cervical cancer prevention. Cervical Intraepithelial Neoplasia (CIN) is a precancerous lesion that histologically can be found in one of three stages of development; CIN-I (low grade), CIN-II, or CIN-III (collectively called high grade), depending on the proportion of the depth of the lesion to the thickness of the cervical epithelium. The higher the degree of CIN, the deeper the pre-cancerous lesions are found in the epithelial lining of the cervix. Therefore, from the point of view of precancerous lesions treatment, its effectiveness will be determined by the ability to eradicate all high-grade lesions. In other words, it has an effect that can reach depths beyond the depth of the high grade lesion.

According to a study in the US (1982), as many as 99.7% of CIN-III cases had a lesion depth of less than 4.8 millimeter. Furthermore, a Netherlands study (1990) stated that as many as 99.7% of CIN-III cases had a maximum lesion depth of 3.6 millimeters. While in subjects from developing countries, study from Peru (2018) showed that 93.5% of CIN-III cases have a lesion depth of less than 5 millimeters. Based on the results of these studies, a treatment for CIN can only be said to be effective if it can create a therapeutic effect which can reach depths of 4-5 millimeters in cervix epithelial.

Trichloroacetic acid (TCA) is an acetic acid analogue, which has long been known as a chemical peel and also frequently used to treat genital ward and precancerous skin lesions. The effect of TCA therapy is the destruction of the epithelium forming epithelial necrosis, followed by re-epithelialization of the supporting tissue and stimulation of collagen synthesis within approximately in 24 hours. There are no studies regarding the depth of cervical necrosis that can be achieved by application of this solution to the cervix epithelial.

Primary Objectives:

The purpose of this study is to determine the depth of epithelial necrosis in cervical tissue specimen after 85 percent TCA application on clinically normal cervix.

Procedure:

Patients will receive a single administration of 1-2 milliliter of 85 percent TCA in 24 hours before elective total hysterectomy surgery on indication other than cervical pathology. The 85 percent TCA will be applied topically onto the ectocervix and the endocervix canal with a cotton swab for 1-2 minutes. After surgery, cervical specimen will be fixated in formalin and sent for histopathologic examination.

Eligibility Criteria:
Inclusion Criteria:

* Normal cervix without significant changes and must be tested negative for Visual Inspection Acetic-Acid (VIA) test (no acetowhite lesions are found)
* Participants are willing to participate voluntarily in this research by signing a consent form.

Exclusion Criteria:

* Patients who finally have undergone sub-total or supra-vaginal hysterectomy.
* Any abnormalities found in postoperative cervical histopathology results.
Pre-anesthetic Evaluation and Cost Reduction

Study conducted in large Brazilian hospital, with the main objective of evaluating the impact of pre-anesthetic in reducing costs related to the preoperative preparation of patients admitted to undergo surgery or diagnostic procedures under anesthesia.

The pre-anesthetic evaluation is essential in the care of surgical patients. Among its benefits stands the reduction of costs related to preoperative preparation. However, most studies evaluating costs was performed in hospitals abroad, whose reality does not always apply to our environment. The aim of this study is to compare the costs of preoperative evaluation performed by the surgeon (conventional tillage), with the cost of preparation performed by the anesthesiologist (pre-anesthetic evaluation). Two hundred patients scheduled for surgical or diagnostic procedures under anesthesia form included in the study. After admission patients were assessed by physician anesthesiologists. In Form 1 (conventional tillage), it was noted tests or specialist consultations made in the preoperative period. In Form 2 (pre-anesthetic evaluation) was noted comorbidities, physical examination and complementary examinations given in accordance with the guidelines adopted by the Anesthesiology Department of the institution. Form data were compared with a data form 2. Besides the costs, we compared the number of tests considered unnecessary and disagreements in the classification of physical status according to the American Society Anesthesiology (ASA).

Eligibility Criteria:
Inclusion Criteria:

* patients over the age of one year and admitted for surgery or diagnostic procedures under anesthesia
* patient did not undergo pre-anesthetic evaluation prior to admission to hospital

Exclusion Criteria:

* Emergency surgery
* Major surgery with hospitalization on a date prior to the operation
Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer

Pegfilgrastim is a long-acting recombinant human granulocyte-colony stimulating factor as support for chemotherapy, which can be used conveniently.

According to the package inserts in America, Europe, and China, the recommended dose for pegfilgrastim is 6mg per cycle, while it is recommended at a dose of 3.6mg in Japan. It is still unclear whether pegfilgrastim 3mg can produce similar efficacy with pegfilgrastim 6mg.

In this trial, the investigators prospectively compared the efficacy and safety of pegfilgrastim 3mg with 6mg in patients with breast cancer receiving AC regimen, a commonly used regimen in adjuvant chemotherapy for breast cancer.

All patients received AC regimen (epirubicin or pirarubincin in combination with cyclophosphamide) intravenously. Epirubicin 90mg/m\^2 (or pirarubicin 60mg/m\^2) and cyclophosphamide 600mg/m\^2 were administered on day 1 of the chemotherapy cycle. AC regimen was administered bi-weekly or 3-weekly.

Eligible patients were randomly assigned to 3mg arm (the study arm) and 6mg arm (the control arm) in a 1:1 ratio, stratified according to body weight (≤60kg or \>60kg). Patients in the study arm and the control arm received a subcutaneous injection of 3mg PEG-rhG-CSF and 6mg, respectively, forty-eight hours after completing chemotherapy infusion.

Eligibility Criteria:
Inclusion Criteria:

* female aged 18-69 years
* diagnosed pathologically as early breast cancer
* with indication for adjuvant chemotherapy and suitable for AC regimen (epirubicin and cyclophosphamide, or pirarubicin and cyclophosphamide, planned chemotherapy with taxanes after AC regimen were allowed)
* received no prior chemotherapy (chemotherapy naïve)
* have Karnofsky performance status ≥ 80,
* baseline hemoglobin ≥90g/L, white blood cell count ≥4.0X10\^9/L,ANC≥2.0X10\^9/L, platelet count ≥100X10\^9
* adequate cardiac, hepatic and renal function

Exclusion Criteria:

* enrolled onto or had not yet completed other investigational drug trials
* allergic to any component of PEG-rhG-CSF injection, or other biological products derived from genetically engineering Escherichia coli;
* pregnant or lactating women;
* previous large volume radiotherapy, or prior bone marrow or stem-cell transplantation
The Diabetes Transition Study for Young People Aged Between 16-20 Years of Age.

Study into the use of a diabetes specialist transition nurse in the care of young people aged 16-20 years, with type 1 diabetes; undergoing transition from the paediatric to the adult diabetes services at the Northampton General Hospital

Does the use of a structured diabetes transition program in the care of young people transitioning from the paediatric to the adult diabetes services at Northampton General Hospital improve the study group mean HbA1C, reduce the number of diabetes related hospital episodes and increase attendance at the adult diabetes clinic following transition to the adult service?

Eligibility Criteria:
Inclusion Criteria:

* established type 1 diabetes for minimum of 1 year
* attended the Northampton general Hospital, children's and young peoples diabetes service for at least 6 months prior to transition
* between the ages of 16 - 20 years
* ability to participate in all aspects of the trial
* written informed consent must be obtained

Exclusion Criteria:

* any condition which may interfere with the subjects ability to participate in the study including cystic-fibrosis related diabetes
* subjects who move away from the Northampton General Hospital clinic during the transition process
* those unable to give informed consent
The Effect of Kinesio-tape® on Pain and Vertical Jump Performance in Active Individuals With Patellar Tendinopathy

Background: Patellar tendinopathy is a common inflammatory condition in athletes who undergo large volumes of running and jumping. Kinesio-tape® (KT) is proposed to provide pain relief; however, its effect has not been examined on patellar tendinopathy. Objective: To examine the effects of KT on pain modulation for active individuals with patellar tendinopathy during functional activities. Methods: Thirteen symptomatic knees from seven college-aged females (6 bilateral; 1 unilateral) were included. Participants underwent three data collection sessions with KT, sham, and no tape (NT) in a randomized order. During the session, participants performed a maximum vertical jump, single-leg squats and isometric knee extension. The KT intervention was applied according to the KT manual and the sham utilized the same pattern without tension. Pain level was evaluated using the numeric pain scale before, during and after each activity. Function was assessed as maximum vertical jump height and maximum isometric strength.


Eligibility Criteria:
Inclusion Criteria:

* Anterior knee pain that increases with jumping and/or squatting
* Pain with palpation at the tibial tuberosity, the patellar tendon, and/or at the apex of the patella
* An insidious onset of this pain.
* Participate in physical activity at least 3 days a week

Exclusion Criteria:

* Injury from direct trauma to the anterior knee
* Medical history of surgery at the knee joint within the past 6 months
* Presence of any lower extremity injuries or non-orthopedic diseases
* Suspected or confirmed pregnancy.
Long Term Effects of Tyrosine Kinase Inhibitor Therapy on Ovarian Reserve and Fertility in Patients With Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor

This pilot research trial studies the long term effects of tyrosine kinase inhibitor therapy on ovarian reserve and fertility in patients with chronic myeloid leukemia or gastrointestinal stromal tumor. Studying ovary imaging, ovarian reserve markers, and hormone levels from patients receiving tyrosine kinase inhibitor therapy may help doctors learn more about the effects of tyrosine kinase inhibitor therapy on ovarian function and fertility.

PRIMARY OBJECTIVES:

I. To collect preliminary information to help design a study to look at longitudinal changes in markers of ovarian reserve and menstruation in premenopausal women undergoing tyrosine kinase inhibitors (TKI) therapy.

SECONDARY OBJECTIVES:

I. Evaluate ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo in vitro fertilization (IVF) for fertility preservation.

OUTLINE:

Patients undergo transvaginal ultrasound for antral follicles analysis and collection of serum for ovarian reserve markers and hormonal analysis before TKI therapy and at 12, 24, and 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic myeloid leukemia (CML), gastrointestinal stromal tumor (GIST), non metastatic cancer where TKI is the first line agent
* Premenopausal (has had menses at any time in the preceding 12 consecutive months)
* Has not undergone a hysterectomy or bilateral oophorectomy
* Willing to use non-hormonal (ie: barrier method or abstinence) as form of contraception during the one year of study

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy in the past
* Patients may not be receiving any other investigational agents
* Patients must not be pregnant or nursing
* Other medical conditions or treatments that affect hormonal levels (potentially confounding interpretation of results)
* Patients with ongoing hormonal contraception or unwilling or unable to discontinue will not eligible
Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients

The main aim of the study is to assess the effectiveness of tailored nutritional intervention in delaying the progression of cachexia to refractory cachexia in adult female cancer patients.

The tested hypothesis stated that intake of nutrient rich bread mix (along with dietary and physical activity counselling) for six months, improved the anthropometric and biochemical indices in free-living patients suffering from cancer cachexia.

Patients were randomly distributed into two groups i.e. control and intervention group. 30 patients were allocated in intervention group and received nutrient rich bread mix i.e. IAtta (100 g) along with dietary and physical activity counseling and 33 patients were allocated in the control group who received only dietary and physical activity counseling. Patients in the intervention group collected 14 packets of 100 g of IAtta every fortnight during their clinician appointments while the control patients were advised regarding their dietary habits at every clinician visit for 6 months.

Dietary counseling for 30 minutes was imparted to all patients on each visit by the researcher. Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), was encouraged daily during counseling sessions.

Nutritional, biochemical, quality of life and anthropometric estimations were assessed at baseline, after 3 months and at 6 months of intervention for all patients.

Patients' daily energy, carbohydrate, protein and fat intake were calculated using food frequency (Indian Migrant study food frequency questionnaire- IMS-FFQ) questionnaire and two day 24 hour recall data. PG-SGA questionnaire was used to monitor patient nutritional status throughout the study.

EORTC-QLQ- C30 questionnaire was used to analyse patients' quality of life and asked personally by the researcher.

Haemoglobin and serum albumin levels were assessed at the start of the study, after 3 months and at 6 months of intervention for all patients.

Indian Migrant Study Physical Activity questionnaire (IMS-PAQ) was used to assess patients' physical activity throughout the day.

Anthropometric estimations included body weight, mid upper arm circumference and four site skin fold thickness (SFT) measurement (i.e. triceps, biceps, subscapular and suprailiac).

Eligibility Criteria:
Inclusion Criteria:

* Female, age 18 years and above.
* Diagnosed with cancer.
* Weight loss \>5% from pre-treatment weight or BMI\<20kg/m2.
* Hemoglobin level \<12 g/dl.
* Energy intake \< 1500 kcal/d (to be assessed on consultation).

Exclusion Criteria:

* Incapable to provide written consent.
* Patient diagnosed with refractory cachexia.
* Life expectancy \< 3 months.
* Unresponsive to anti-cancer therapy.
* Patient is a pregnant woman or a nursing mother.
* Suffering from secondary illnesses.
* Gastrointestinal tract defects which affect nutrient absorption