cyrilzakka/clinical-trials huggingface dataset:
Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma With Positive Circumstantial Resection Margin

The purpose of this study is to determine the efficacy of adjuvant radiotherapy for esophageal squamous cell carcinoma with positive circumstantial resection margin.

Although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, the considerable number of esophageal cancer patients received operation as the first treatment modality. Accordingly, postoperative treatments have been playing an important role because of the poor survival rates of the patients who have been treated with resection alone. The existing data shows that the 5-yeal survival rate of stage T2-3N0M0(UICC 7th edition) of thoracic esophageal squamous cell carcinoma(TESCC) after surgery is about 50% ,and locoregional lymph nodes metastases is responsible for the main cause of failure while distal metastases account for relatively less ratio. Therefore, the subclinical residual tumor is affirmative even if the early disease has been undergone curable excision and local adjuvant treatment may be essential. In rectal cancer, the involvement of the circumferential resection margin (CRM) is one of the key factors for local recurrence and poor prognosis,based on reports in which CRM with \< 1mm was found to be prognostically significant, whereas the clinical and prognostic significance of the CRM involvement in EC has been investigated only in a few series showing conflicting results, as some studies suggest a significant influence of CRM. There is lack of clear evidence for prophylactic radiation therapy in positive Circumferential Resection Margin(CRM) patients of TESCC now. In view of this, the randomized controlled trial will determine the clinical efficacy and toxicity of adjuvant radiotherapy in positive Circumferential Resection Margin(CRM) for thoracic esophageal squamous cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

Patients with esophageal cancer who received R0 operations in Fudan University Shanghai Cancer Center and postoperative pathology: squamous cell cancer,positive Circumferential Resection Margin(CRM)+

* KPS≥70 before radiotherapy;
* Did not receive neoadjuvant or adjuvant treatment;
* No clear recurrent or metastatic lesions before radiotherapy;
* Intensity modulated radiation therapy(IMRT) is accepted;
* Regular follow-up.

Exclusion Criteria:

* Exploratory thoracotomy or palliative surgery;
* No clear recurrent or metastatic sites;
* Recurrence or metastasis is not certain;
* death of no definite cause.
* Irregular follow-up;
Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)

The purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients.

Three-thousand or 10% of total number of patients given tigecycline will be included in the study

Eligibility Criteria:
Inclusion Criteria:

* All patients from the study center who received or will receive at least one dose of Tygacil according to the approved product indication.

Exclusion Criteria:

* Previously discontinued Tygacil therapy due to significant safety concern.
Cognitive Effects of Exercise in Parkinson's Disease

This pilot study will evaluate the short-term (3 months) and long-term (6 months) effectiveness of a high-intensity interval training (HIIT) program in improving cognitive function and self-efficacy in individuals with PD.

Participants will be assigned to either the HIIT group, which will engage in 3 classes per week, or a standard-of-care control group, which will include people who will continue their standard care and usual physical activities but do not plan on partaking in additional structured exercise interventions for 3 months (except for physical and occupational therapy if medically necessary). Cognitive functions will be measured using standardized tests (Stroop, Trail Making Test-B (TMT-B), verbal fluency (using letters F-A-S), and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)), alongside assessing subjective ratings of daily cognitive function using the Neuro Quality of Life - Cognitive Function (Neuro-QoL CF) survey. Secondary outcomes will include self-efficacy measures, specifically regarding goal achievement, managing emotions and daily activities. We will also aim to obtain brain functional MRI (fMRI) and neuromelanin-sensitive MRI (NM-MRI) data from a subset of participants to measure the brain effects of HIIT as exploratory outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease
* Age 40 year and above
* Willingness and ability to participate in HIIT exercise classes

Exclusion Criteria:

* Non-English speaking
* Neuropsychiatric disorder other than Parkinson's disease and comorbid depression and anxiety (e.g., stroke, epilepsy, brain tumor, multiple sclerosis, schizophrenia, bipolar disorder, obsessive compulsive disorder, etc.)
* High levels of exercise at baseline (exercising at high intensity at least 3 times per week or moderate intensity at least 5 times per week)
* Hoehn \& Yahr disease stage \> 3 (physically not independent)
Psychosocial Treatment for Women With Depression and Pain

Patients with depression and pain have poorer outcomes in response to depression treatments than depressed patients without pain. While psychotherapy treatment studies have demonstrated improvement in pain and depression, no psychosocial interventions have been developed and tested prospectively specifically for patients with both conditions. Interpersonal psychotherapy (IPT), an effective treatment for depression, has been adapted successfully for physically ill patients and demonstrates good adherence, treatment satisfaction, and depression outcomes. The investigators propose to test a modified form of IPT-P for depressed patients with co-morbid pain.


Eligibility Criteria:
Inclusion Criteria:

* major depression
* chronic pelvic pain

Exclusion Criteria:

* current or past psychosis
* moderate mental retardation or greater
* active suicidal intent
* active abuse of non-prescribed substances (\< 3 months)
* current individual psychotherapy
* current pregnancy
* terminal illness
* inability to communicate in English
* men
Functional Genetic Variants Affecting Tacrolimus Trough Levels and Side Effects in Chinese Renal Transplantation.

The purpose of this study is to determine whether functional genetic variants can affect tacrolimus dose corrected trough levels and associate with the side effects in Chinese renal transplant recipients.

Tacrolimus is an effective immunosuppressive drug widely used in solid organ transplantation to prevent rejection. It is characterized by a narrow therapeutic range and large inter- and intra- individual variability in its pharmacokinetics. Many factors are associated with the variability. Of these factors, genetic factor play an important role. Full understanding of this mechanism is important for the personalized use of tacrolimus and reducing the risk of side effects.The CYP3A5\*3 (A6986G) resulting in a splicing defect and the absence of protein activity, was identified as a functional variant (Kuehl P.2001). The CYP3A4\*1G was also reported as a functional variant (Richards-Waugh LL. 2014). In addition, other functional variants will also be identified and analyzed in our project.

Our project has two parts:first, retrospective study, 839 renal transplant recipients using tacrolimus as immunosuppressive drug were recruited from Nanfang Hospital. Fifty-eight SNPs from GWAS, GTEx and promoter region of CYP3A gene were genotyped. The association of 58 SNPs on the dose corrected tacrolimus trough levels and side effects (acute rejection, nephrotoxicity and neurotoxicity) were analyzed. Luciferase reporter gene assay were used to identify the functional variants. Second, in this part, there is another renal transplantation cohort. For this cohort, it was a retrospective cohort. All the patients will be stratified to different groups according to the different genotypes. The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be observed.During the study period, all the therapeutic procedures of the patients are as usual.

This will be the largest cohort of this kind of study in Chinese population. The findings will be useful for the patients to improve the therapeutic efficacy and reduce the side effects.

Eligibility Criteria:
Inclusion Criteria:

Subject has been conducted kidney transplantation. Subject has used tacrolimus as immunosuppressant.

Exclusion Criteria:

Simultaneous liver-kidney transplantation. Patients with age less than 18 years old. Tacrolimus blood concentration monitoring less than 3 times. Failed to extract DNA.
AeviceMD for Detection of Wheeze in Pediatric and Adult Populations

Respiratory signs and symptoms consisting of wheeze, cough, and breathlessness are obtained in a manual fashion through history taking and physical examination by the healthcare professional. Auscultation of the lung assesses airflow through the trachea-bronchial tree and is helpful in diagnosing various respiratory disorders. AeviceMD is a wearable device that can acquire and process lung sounds, thus assisting in the detection of abnormal lung sounds. The primary objective of this study is to determine if AeviceMD can detect wheeze of pediatrics and adults as accurately as a physician through auscultation. The secondary objective is to investigate if AeviceMD can be used for remote auscultation of breath sounds.


Eligibility Criteria:
Inclusion Criteria:

* The subject is willing and/or parents/guardians are able to give informed consent for participation in the study.
* Male or Female, aged ≥ 3 years.
* Diagnosed with acute asthma exacerbation by an ED provider.

Exclusion Criteria:

* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subjects at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.
Effect of Using Educational Robots During Vaccination on Fear and Pain in Children

Pain and fear are very common in children during vaccination. We are planning to conduct a study to help children go through this process more comfortably. The aim is to examine whether the educational robot has an effect on pain and fear during vaccination in 4-year-old children in a randomized controlled manner.

Data Collection Method:

A sample group of 74 people will be divided into two groups using www.randomizer.org using a simple randomization method.

Intervention group: The child patients in this group will be given the opportunity to get to know, touch and examine the educational mini robot for 5 minutes before the DaBT-IPA vaccination. The robot will attract the child's attention. During this time, the sociodemographic data form will be filled. At the end of the 5th minute, the child patient will prepare the vaccination with the cooperation of the staff and parents. During this time, the researcher will maintain the child's relationship with the robot and ensure that he/she focuses his/her attention on the robot. The application will end after the DaBT-IPA vaccination process. 5 minutes after the procedure, the Child Fear Scale (ÇKÖ, Wong Baker Pain Scale) will be filled by the researcher using a face-to-face interview technique. The robot will be cleaned with antiseptic solution after each child patient. Control Group: After the procedure is explained according to the child's developmental level, the DaBT-İPA vaccine will be administered in accordance with the institution's policies. 5 minutes later, the Sociodemographic data form, Child Fear Scale (ÇKÖ, Wong Baker Pain Scale) will be filled by the researcher using a face-to-face interview technique. At the end of the data collection, the control group will be provided with the opportunity to spend time with the robot in order to be beneficial.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* The child must be 4 years old
* Must have come to a primary care center in Balıkesir city center
* DaBT-İPA vaccination must be administered
* Vastus Lateralis muscle must be used in vaccination

Exclusion Criteria:

* Not volunteering to participate in the study
* The child is not 4 years old
* He/she has not come to a family health center in Balıkesir city center
* DaBT-İPA vaccination is not applied
* Vastus Lateralis muscle will not be used in vaccination application
Risk Factors and Molecular Genomics of U.S. Patients With Chronic Liver Disease and Hepatocellular Cancer

To identify risk factors for the development and diagnosis of hepatocellular CA in patients with chronic hepatitis C and to use the data to ultimately develop an effective screening program.


Eligibility Criteria:
Inclusion Criteria:

* For both experimental subjects and controls:

  1. Patients between older than 18 years of age of all ethnic backgrounds and genders.
  2. Patients with chronic liver disease
* For Experimental Subjects Only:

  1. Patients with HCC with a hepatic mass larger or equal to 5cm
  2. Patients with HCC with a hepatic mass lesion confirmed by fine needle aspirate (FNA) or by pathology in the cases of surgical resection
  3. Patients with HCC with a hepatic mass lesion with characteristic CT or MRI or angiographic appearance.
* For Controls Only:

Patients with chronic liver disease without evidence of HCC confirmed by either :

1. A normal AFP level

2. a negative imaging study (ultrasound, CT, or MR imaging).

3. Negative liver cancer on explants.

\*Exclusion Criteria:

1. Patients who declined to participate in the study
2. Patients with a history of HIV infection
3. Patients with concurrent advanced malignancy of non-hepatic origin.
4. Patients with significant use of androgenic steroid.
5. Patients with exposure to vinyl chloride.
Treatment for Insomnia During Pregnancy

The aim of the study is to improve sleep during pregnancy and the postpartum period in women who are experiencing insomnia, using a brief non-pharmacological treatment.


Eligibility Criteria:
Inclusion Criteria:

* Meets Diagnostic and Statistical Manual (IV-TR edition) criteria for insomnia (duration criterion - 1 month)
* Pregnant with gestational age between 18-32 weeks.
* Adequately fluent in English or Spanish.

Exclusion Criteria:

* Some co-morbid sleep disorders (e.g., moderate to severe obstructive sleep apnea)
* Co-morbid psychiatric disorder
* Use of medications, herbs or other drugs with known effects on sleep
* Unstable medical conditions
* Currently engaged in psychotherapy or other treatments for insomnia
Postmarket Study of an Intraocular Lens Power Selection System

The purpose of the study was to evaluate the visual acuity outcomes when using the Optiwave Refractive Analysis (ORA) with VerifEye+ and Barrett Toric Calculator for calculating intraocular lens (IOL) power and axis in subjects requiring cataract surgery and implanted with a toric IOL in both eyes.

Surgery was done on each eye on different days, 7 to 14 days apart. Subjects were seen for a total of 10 visits with a follow-up duration of 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Planned cataract surgery with IOL implantation
* Able to comprehend and sign the informed consent form
* Preoperative astigmatism of 0.75 to 3.00 Diopter
* Willing and able to complete all required postoperative visits
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Unclear intraocular media other than cataract
* Pregnant or lactating
* Presence or history of any condition or finding that makes the subject unsuitable as a candidate for cataract surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator.
* Other protocol-defined exclusion criteria may apply
A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.


Eligibility Criteria:
Inclusion Criteria:

* Have one of the following solid tumor cancers:

  * Cohort A1: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), pancreatic, and colorectal cancer (CRC)
  * Cohort A2/A3/A4/A5/B1/B2: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer
  * Cohort C1/C2: Endometrial cancer, cervical cancer, NSCLC, TNBC, CRC or pancreatic cancer

Exclusion Criteria:

* Individual with known or suspected uncontrolled central nervous system (CNS) metastases
* Individual with history of carcinomatous meningitis
* Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
* Individual with evidence of corneal keratopathy or history of corneal transplant
* Any serious unresolved toxicities from prior therapy
* Significant cardiovascular disease
* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
* History of pneumonitis/interstitial lung disease
* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
Ease of Use Study of the FemPulse System

The objective of the study is to demonstrate that the FemPulse System can be used as indicated

The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Patient and Clinician Instructions for Use (IFU), as applicable.

Eligibility Criteria:
Key Inclusion Criteria:

1. Females, defined as a person with a cervix, ≥21 years old, with OAB symptoms, as confirmed by a physician. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms .
2. Able to read, comprehend, and reliably provide informed consent and study-related information.
3. Willing and able to comply with study required procedures and visits

Exclusion Criteria:

1. Any significant pain, neurologic, psychological condition or other factors, that in the investigator's judgment, might confound the protocol study assessments, and adherence to the protocol.
2. Has a metal pelvic implant or an active implantable medical device, including but not limited to a cardiac pacemaker, cardioverter-defibrillator or neurostimulator 3 History of a cardiac condition including, but not limited to, clinically significant abnormal ECG or arrhythmia that may interfere with study participation as determined by investigator.

4. Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator.
Mediolateral Episiotomy in Nulliparous Women Increases the Risk of Sexual Dysfunction

Postpartum sexual functions may be affected in women who have had a vaginal delivery by performing an episiotomy. The aim of this study is to compare the frequency of sexual dysfunction between women who were delivered with a mediolateral episiotomy and those who were delivered without an episiotomy.

Materials and Methods: A total of 179 women who gave birth in a tertiary center were included in the prospective study. The patients were divided into two groups as women with and without mediolateral episiotomy. The groups were compared in terms of age, body mass index, educational status, and hospitalization time for delivery and Arizona sexual experiences scale (ASEX).

All patients were called up for a control in 6th month after delivery and sexual funciton was evaluated according to The Arizona Sexual Experience Scale (ASEX). In our study, we used the ASEX test, age, education level, BMI and time spent in hospital for delivery to investigate sexual dysfunction in healthy women who had a vaginal delivery with or without mediolateral episiotomy. The ASEX test is a 5-question survey. In the questionnaire, women were questioned for sexual drive, arousal, vaginal lubrication, ability to reach orgasm, satisfaction from the orgasm. Women gave points from 1 to 6 and their results were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women who gave birth at term
* No smoking or alcohol consumption
* Chronic illness
* Spontaneous labor( The labor was defined as cervical dilatation of at least 2cm with at least 80% of effacement with regular contractions or 4cm dilatation with any effacement with regular contractions or the flow of amniotic fluid.

Exclusion Criteria:

* Exclusion criteria were need of labor induction,
* history of any pregnancy complication (gestational diabetes, hypertension, oligohydramnios, any suspicion of infection or chorioamnionitis...etc.),
* history of multiparity,
* history of sexual dysfunction,
* history of vaginal surgery and frequent vaginal infection.
Adaptation of Community Reinforcement Approach for the Treatment of Drug Addiction

Central idea of the study is to adapt a treatment program for drug addiction treatment indigenously and relapse prevention, and to establish its efficacy.

This study helps the society to have an evidence-based approach with proven efficacy to deal with drugs related issues in Pakistan along with minimizing the rate of relapse which is the major issue with current disease model for treatment of addiction in different rehabs within the country.

Present study's aim is to adapt culturally and islamically a robust treatment protocol: Reinforcement Approach (CRA) through randomized control trial to determine its efficacy in the field of drug addiction rehabilitation. Moreover, CRA is also be used with comorbid psychological illnesses. Because, in the treatment facilities disease model is currently prevailing which lacks empirical evidence, and they do not have proven efficacy.

In this study CRA is adapted and prepared as a protocol for residential treatment for drug addiction and drug induced psychosis as well. Intervention is applied to patients admitted to Islamabad Rehab Clinic (IRC). 90 days treatment plan is developed based on CRA interventions along with religious interventions. These religious interventions are based on Islamically Integrated psychotherapy. After discharge from the treatment every participant will be monitored for next 3 months through follow up session with patient and caregivers as well.

In CRA, face to face interaction is required for intervention including 8 sessions for focuses on the reality of client's social environment so that for learning real life opportunities could be focused as per client needs to enhance engagement and learning.

For internal motivation and involvement in CRA, adaptations were added to enhance CRA's effectiveness. There were two major adaptations in CRA to make it accord with the cultural relevant with the targeted population. First adaptation is based on religion Islam. It includes several sections, and these sections are adapted in CRA's counseling goals. In first section morality is being adapted with CRA, morality is about the Islamically integrated ways about hygiene, sleep, eating, clothes, meeting others, physical health, happiness and sadness related. Second section is related to internal framework of human psyche, which comprises of Cognition (Aql), Behavioral inclination (Nafs), Sprit (Ruh), Emotion (Ihsaas) and Heart (Qalb). In third section principle of change and tazkia e nafs. There are three stages in principle of change: 1.Inkishaf, 2. Itidal and 3. Itehad.

Second adaptation is about the effective coping skills related therapeutic intervention, which is comprises of four distinctive categories such as emotional management, interpersonal effectiveness: assertiveness, habit formation and relapse prevention counseling.

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted for treatment of drug addiction with or without comorbid psychological disorders.

Exclusion Criteria:

* Patient with no history of drug abuse.