cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Combined Intervention Approaches in the Treatment of Affective Disorders and Chronic Pain in War Victims

This study will measure the effects of biofeedback supported cognitive behavioral therapy (BF-CBT) and group physiotherapy intervention in victims of torture and massive violence in Kosovo. The investigators aim to restore physical and psychosocial functioning of the victims of torture and massive violence with available rehabilitation practice and integrate them into the community. It is also our objective to build local knowledge and expertise to apply measurement principles and CBT methods in the Balkan region.

The primary objective of this project is to contribute to the promotion of evidence-based health intervention which is dealing with the long-term consequences of trauma in the post-conflict Kosovo.

This is the second phase of a series of multi-site case studies. Based on the knowledge generated in the first phase of project in 2007-2009, the investigators conclude that there is a need to continue with health interventions in northern Kosovo among those who are still suffering from the long-term effects of trauma. Many problems need to be addressed, ranging from unemployment and sleep disturbances to a high suicide rate. As our study shows, the situation is frequently complicated by co-morbidity between mental and physical problems, in particular, anger, hatred, severe depression and chronic pain.

At this phase, the investigators aim to provide the available rehabilitation service to the victims of torture and massive violence in northern Kosovo. The investigators undertake an integrated intervention approach; that is a biofeedback supported cognitive-behavioral therapy (BF-CBT), which involves anger management, anxiety and phobia treatment (based on prolong exposure therapy)and a group physiotherapy intervention, which promotes physical fitness and social participation. The ultimate goal of this project is to determine both feasibility and the effectiveness of combined interventions in the countries with limited resources.

Eligibility Criteria:
Inclusion Criteria:

* Victims of massive violence from northern Kosovo who reported one or more of the following experiences: 1) torture and other cruel, inhuman or degrading treatment or punishment (TCIDTP); 2) sexual harassment, molestation, rape or insertion of a blunt object into a genital organ and/or the rectum; 3) arrest and detention without warrant or order; or 4) extrajudicial execution of family members, perpetrated by members of law enforcement agency.
* Clinical diagnosis of PTSD and one of following symptoms: depression, anxiety or chronic pain

Exclusion Criteria:

* With mental retardation or significant speech or cognitive impairment that would impede assessments
* With past or present schizophrenia
* With major alcoholic or substance abuse problems
* Having recently undergone chemotherapy or chemo-radiotherapy for cancer or will have these therapy within following 6 months,
* Having had any CBT in the past three years
Bupivicain vs Bupivicain Plus Dexamethasone in ESP Block for Post-op Analgesia

Thoracotomy is a very painful procedure. Different treatment modalities are being utilized for post-thoracotomy analgesia including I/V NSAID, Opoids and Neuropathic medications. Other techniques commonly utilized include Thoracic epidural, Paravertebral block; but both are associated with significant failure rate and other complications. Ultrasound guided Erector Spinae Plane block is a new regional anesthesia technique that provides analgesia at multidermatomal levels acriss the posterior, lateral and anterior thoracic walls. The rational of my study is that it is a novel technique and studies with bupivicain alone are present but no study was found with bupivicain plus dexamethasone.


Eligibility Criteria:
Inclusion Criteria:

* age 18-60years ASA I-III Patients undergoing elective thoracotomies

Exclusion Criteria:

* Refusal of Patient Coagulation disorders Known Allergy to Local Anesthetics Infection at the site of injection Pregnant females Morbid Obesity(BMI\>40kg/m2) Psychiatric illness Diabetic Patients.
A Phase I Clinical Study Study of the Safety, Tolerability, and Pharmacokinetics of HX-1171 in Healthy Male Subjects

This study is designed to evaluate the safety, tolerability, and pharmacokinetics of HX-1171 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Adult males aged 20 to 40 years at screening.
* Be able to comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or gastrointestinal disorders.
* History of known hypersensitivity to drugs including HX-1171.
The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer

The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine.

This study is for patients with previously diagnosed advanced non small cell lung cancer (NSCLC, stage IIIb or IV) who had progression of their disease during or after first-line therapy containing platinum. Patients will be assigned to receive 6 cycles of therapy from one of four treatment regimens:

* docetaxel
* docetaxel + vinorelbine
* docetaxel + gemcitabine
* docetaxel + capecitabine

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \> 18
* Histological diagnosis of non small-cell lung cancer (NSCLC)
* Stage IIIb or Stage IV disease (in IIIb, previous treatment with chemotherapy + radiotherapy, or metastatic supraclavicular lymph nodes or pleural effusion)
* Disease in progression
* Previous chemotherapy with platinum-derivative (and with \> 21 days from last administration)

Exclusion Criteria:

* ECOG performance status \> 2
* Age \> 75 years
* History of malignant neoplasm within the previous 5 years (except for baso- or spino-cellular skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
* Previous treatment with docetaxel
* Presence of symptomatic cerebral metastasis
* Neutrophils \< 2.0 x 109/l, platelets \< 100,000/l, hemoglobin \> 10g/dl
* Bilirubin \< 1.5 x the upper normal limit
* SGOT , SGPT, or bilirubin \> 1.25 x the upper normal limits except in the presence of hepatic metastasis
* Creatinine \>1.25 x the upper normal limit
* Any concomitant pathology that would, in the Investigator's opinion, contraindicate the use of the drugs in the protocol
* Inability to comply with follow up
* Pregnant or nursing females
The Effect of Teenage Maternity on Obstetrical and Perinatal Outcomes

The purpose of this study is to estimate the effect of maternal teenage on pregnancy and perinatal outcomes among Caucasian pregnant women.

During the past decade in the United States, approximately 10 percent of teenage girls from 15 to 19 became pregnant. According to the National Vital Statistics Report 2009 seventy of one thousand births in the United States accounted to teenagers from 15 to nineteen years of age during in 2005 and fell to forty per 1,000 women in 2006. In contrary, the overall teenage birth rate lay at twenty- two per 1,000 births in Massachusetts in 2007 ranging from seventy to thirteen per 1,000 women for Hispanic vs. white women aged 15- 19 years. Central European data showed equal results for teenage pregnancy birth rates. According to the German National Institute of Vital Statistics thirty-four of one thousand births in Germany accounted to teenagers younger than 20 years of age. This pattern is a source of concern since teenage mothers have an increased risk of having low-birth- weight babies, premature babies, and babies who die during the first year of life. Additionally, teenage mothers are more likely to suffer from other concomitant pregnancy diseases such as preeclampsia or anemia.

Furthermore, teenage mothers are more likely than older mothers to be poor, less well educated, non- white, unmarried and they are less likely to have received early prenatal care. Dealing with pregnant adolescents therefore means a great challenge in modern obstetrics. Previous research has shown racial differences as well as weight differences for increased risk of adverse prenatal outcome among African Americans and teenagers. Taking into account the impact of race on pregnancy outcomes, our goal was to examine the relationship of young maternal age on obstetrical outcomes in a predominantly Caucasian central European teenaged population.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparity
* Maternal age of \< 18 years for group A and
* Maternal age \>/= 18 years for group B

Exclusion Criteria:

* Preterm delivery \< 24 + 0 weeks of gestation post menstruation
* Confirmed multiple pregnancy
* Maternal and fetal co morbidity
* Presentation other than cephalic presentation and incomplete data
Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women

This study is a multi-site, randomized, opened and parallel-controlled clinical study.

The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks. Before the dosing and at Week 4, 8 and 12 of the dosing, various examinations are made, and various indices are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women aged ≤75.
* Signing of ICF.
* Willing to and able to correctly complete the urination diary.
* Complications of OAB for ≥12 weeks (including: urgent micturition, frequent urination (≥8 times in the daytime, and ≥2 times at the night) and/or urgent urinary incontinence).
* No dosing of other drugs of same kind within 14d. -≥8 urination times (24h) in the 1d urination diary.

Exclusion Criteria:

* Clinically-significant dysuria(at the investigators' viewpoints).
* Serious stress urinary incontinence or mixed stress/urgent urinary incontinence (mainly stress one) confirmed by the investigators.
* At the ongoing intubatton or the intermittent self-intubatton.
* Evidence-based urinary tract infection or chronic inflammation in the recent 2 weeks (e.g. interstitial cystitis), bladder calculus, past pelvic radiotherapy, and past or existing pelvic malignant tumors.
* Uncontrolled narrow-angle glaucoma, urinary/gastric retention, intestinal obstruction and other medical symptoms forbidden for anti-cholinergic drugs at the investigators' viewpoints.
* Non-pharmacotherapy (including electrotherapy) or bladder training within 2 weeks before the study initiation (or during the study).
* Dosing of diuretics and drugs with the cholinergic or anti-cholinergic adverse reactions
* Known or suspicious allergy to Solifenacin Succinate, other anti-cholinergic drugs or lactose.
* Clinically-significant symptoms inapplicable for clinical study at the investigators' viewpoints.
* Participation in other clinical studies within 30d before the random grouping.
* No completion of urination diary according to relevant instructions.
* Potentially clinically significant abnormalities (PCSA) inapplicable for clinical study at the investigators' viewpoints.
CBM588 Reduces Colorectal Polyp Recurrence

The goal of this randomized crossover clinical trial is to evaluate the efficacy of Clostridium butyricum MIYAIRI 588 (CBM588) in reducing colorectal adenomatous polyp recurrence in adult patients with a history of colorectal polyps.

The main questions it aims to answer are:

* Does CBM588 reduce the recurrence of colorectal adenomatous polyps?
* Does CBM588 lead to a sustained decrease in polyp burden over time? Researchers will compare a group receiving CBM588 in the first year to a group receiving CBM588 in the second year (after a washout period) to determine whether CBM588 effectively lowers polyp recurrence rates and adenoma prevalence.

This randomized crossover clinical trial evaluates the effect of Clostridium butyricum MIYAIRI 588 (CBM588), a butyrate-producing probiotic, on colorectal adenomatous polyp recurrence. Participants who had undergone complete polypectomy were randomly assigned into two groups:

* Group A: Received CBM588 for one year, followed by a washout period and no treatment in the second year.
* Group B: Did not receive CBM588 in the first year but received it in the second year after a washout period.

Annual colonoscopy assessments were conducted to evaluate polyp count, type, and location. The primary outcome measure is adenoma recurrence. This study was conducted at a tertiary medical center and received Institutional Review Board (IRB) approval (KMUHIRB-F(I)-20170010). All participants provided informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Adults who have undergone complete polypectomy for newly detected colorectal polyps
* Willingness to undergo follow-up colonoscopies at study intervals
* No antibiotic or probiotic use for at least three months before study entry
* Written informed consent obtained

Exclusion Criteria:

* History of colorectal cancer or other gastrointestinal malignancies
* Diagnosis of inflammatory bowel disease or familial adenomatous polyposis
* Use of antibiotics and other probiotics during the study period
Relative Bioavailability of BI 691751 Administered With and Without Food to Healthy Male Subjects

The primary objective of this trial is to investigate the relative bioavailability and pharmacokinetics in plasma and whole blood of BI 691751 administered as a single dose with and without food in healthy male subjects.


Eligibility Criteria:
Inclusion criteria:

1. Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogramm (ECG), and clinical laboratory tests
2. Age 18 to 50 years (incl.)
3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)

Exclusion criteria:

1. Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and 12-lead Electrocardiogramm (ECG)) deviating from normal and judged clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention

This study evaluates the feasibility of a clinical informatics system-based approach to lung cancer screening. Patients of a large academic medical center who may qualify for lung cancer screening will be sent an electronic invitation to complete an online lung cancer screening decision aid.

The Center for Medicaid and Medicare Services (CMS) recently approved the use of low-dose chest CT scans for lung cancer screening in patients who meet specific criteria. However, many individuals who meet these criteria do not realize they qualify for screening. This study will determine the feasibility of using a clinical informatics approach to systematically identify potential candidates for LDCT screening, reach out to them via the patient portal, and use a web app to provide them with a personalized LDCT screening decision aid and facilitate the ordering of screening tests.

Eligibility Criteria:
Inclusion Criteria:

* Has an active patient portal account
* Scheduled to see a Wake Forest primary care provider within the next 4 weeks

Exclusion Criteria:

* Never smokers
* Current or former history of lung cancer
* Receipt of chest CT scan within last 12 months
* Need for a language interpreter
* Presence of disease predicting short life-expectancy
Digital Weight Bearing Shape Capture Socket Technology

The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability \& functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.

This study will compare the use of Symphonie Aqua Digital System, which is a new way to create a socket for prosthetics, to the current method that is generally used to create sockets. The study will look at the differences in comfort and fit between the Symphonie Aqua Digital System and the current standard of care (SOC).

The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability \& functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and above
* Unilateral trans-tibial amputees
* Ambulate at a K3 level or higher
* At least 3 months post-amputation per physician discretion
* Trans-tibial limb length greater than 4.5 inches in length
* Able to follow directions and independently give informed consent
* Must be able to ambulate without assistance

Exclusion Criteria:

* Age \< 18 years
* Conditions that prevent wearing a prosthetic socket
* Soc Socket made with weight bearing system
* Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
* Women who are pregnant or who plan to become pregnant in the near future
* Weight \> 280 lbs
The Cutoff Point for Caval Index and Its Correlation With Central Venous Pressure and Plasma Lactate Level for Assessing Patients in Hypovolemic Hemorrhagic States

The purpose of this study is to determine the cutoff point for IVC collapsibility index (by Bedside Ultrasonographic technique) for cases in hypovolemic hemorrhagic shock with CVP measures less than 8 cmH2o.


Eligibility Criteria:
Inclusion Criteria:

* Hypovolemic hemorrhagic subjects (class II or more)if they were more than 18 years old and CVC insertion was indicated for them.

Exclusion Criteria:

* a history of Renal failure, Congestive Heart Failure, use of negative inotropic agents, presence of any contraindication for CVC insertion or failed ones and inability for measuring IVC by bUS were considered for exclusion.
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy

The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via ventricular fibrillation (VF) in patients who have a Class I or II A indication for ICD implantation, and thus to promote the "painless" therapy aspect of ICD treatment and improve quality of life outcomes for patients.

Main objective: Compare \& quantify efficacy of two different sequences of burst ATP strategies for the termination of ventricular tachycardia (with Cycle Lenght (CL) of 240ms-320ms) from baseline to 12 months post randomisation in patients who are treated with ATP -8 pulses, 88% versus patients who are treated with ATP -15 pulses, 88%

Secondary objectives:

* Estimate the efficacy of ATP in successfully treating FVT episodes for patients in primary and secondary prevention
* Estimate acceleration rate or degeneration of ATP therapy for treating spontaneous FVT episodes in the ATP 15 vs 8 arm
* Compare the likelihood of syncopal events associated with spontaneous FVT episodes
* Estimate the percent reduction in number of shocks delivered per patient for treating spontaneous FVT episodes
* Evaluate different possible predictors of ATP success: VT rate, underlying disease, Anti-Arrhythmic Drugs (AAD), infarct zone, etc.

Eligibility Criteria:
Inclusion Criteria:

* ICD indications (Class I-II A) according to the guidelines (patient with coronary artery disease \[CAD\] or non-CAD in primary or secondary ICD prevention)
* Patients have been implanted with a Medtronic Marquis family ICD capable of ATP for FVT via VF

Exclusion Criteria:

* Patient's life expectancy less than 1 year due to a non-cardiac chronic disease
* Patient on heart transplant list which is expected in \< 1 year
* Patient's age less than 18 years
* ICD replacements and upgrading (single chamber \[SC\] ICD® dual chamber \[DC\] ICD)
* Unwillingness or inability to provide written informed consent
* Enrollment in, or intention to participate in, another clinical study during the course of this study
* Inaccessibility for follow-up at the study center
* Ventricular tachyarrhythmias associated with reversible causes
* Brugada syndrome, long QT and hypertrophic cardiomyopathy (HCM) patients
* Other electrical implantable devices (neurostimulators, etc.)
* Mechanical tricuspid valve
The Effect of Continuous Egg Supplement on Personalized Nutri-omics in Primary School Children (SI-EGG STUDY)

This research compares the effects of one-year continuous whole egg supplement vs. egg yolk substitutes and control on anthropometry, biochemical blood parameters, metabolic enzymes and microbiome data in primary school children.

This research study determine the long-term effects of egg supplementation on growth, blood lipoproteins, blood proteins, nutritional status, metabolic enzymes and microbiomes in children, enrolling in the school lunch program.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 8-14 years

Exclusion Criteria:

1. Allergic of eggs
2. People who cannot continue to follow up the protocol

4. Having contra-indication i.e. problems with blood clotting
Caelyx as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease and/or Age Over 65 Years

This is a multicenter study of a primary chemotherapy regimen in breast cancer patients at risk of developing cardiotoxicity. The aim of the study is to evaluate the response rate at surgery.

This is a phase II, uncontrolled, open label, multicenter study of a primary chemotherapy regimen consisting of four cycles of liposomal pegylated doxorubicine 35 mg/m² IV plus cyclophosphamide 600 mg/m² on Day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery in breast cancer patients at risk of developing anthracycline-induced cardiotoxicity.

Surgery (tumorectomy, quadrantectomy, or mastectomy plus lymphadenectomy) will be performed 2 to 5 weeks after the last primary chemotherapy infusion.

Patients with \> 10% of hormone receptor-positive cells will receive appropriate hormone therapy according to menopausal status.

Patients treated with breast-conserving surgery will receive radiation therapy to the mammary gland.

Patients with T4 tumors or significant axillary involvement (≥ ypN2) will receive radiation therapy to the breast or chest wall and to the lymph node chains.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast cancer (tumor \> 2 cm).
* Estrogen receptor-negative or -weakly positive tumors (less than 50% of cells), as evaluated using IHC.
* Risk factors for developing anthracycline-induced cardiomyopathy.

Exclusion Criteria:

* Severe heart failure (NYHA Class III or IV) .
* Metastatic disease.
* LVEF \< 45%.
* Pregnant or breast-feeding patients.