cyrilzakka/clinical-trials huggingface dataset:
Improving Patient Outcome in Group Therapy for Eating Disorders

The current trial aims to investigate the impact of continuous feedback on dropout and outcome in group therapy. The hypothesis is that continuous feedback to patient and therapist on treatment progress and alliance will 1) increase adherence and 2) increase treatment outcome.

Background: In the psychotherapy of eating disorders, a dropout rate between 30% and 50% is reported internationally. The fact that up to half of the patients drop out of treatment calls for ways to improve it. Research shows that feedback to patient and therapist increases outcome and reduces the number of dropouts; however there is only three published works on the effect of feedback in eating disorders treatment. Therefore, the present trial, at the eating disorders unit at Stolpegaard Psychotherapy Centre, Gentofte, Denmark, may contribute to necessary improvements in the field.

Objective: The current trial, which will be conducted from August 2012 to August 2014, aims to investigate the impact of continuous feedback on adherence and outcome in group psychotherapy. The hypothesis is that continuous feedback to patient and therapist on treatment progress and alliance will 1)increase adherence 2) increase treatment outcome.

Method: The trial is set up in a randomized design with 159 patients allocated to a) treatment with feedback intervention or b) treatment as usual.

Participants: The participants are diagnosed with Bulimia Nervosa, Binge Eating Disorder or Eating Disorder Not Otherwise Specified.

Interventions: In the experimental group, two sets of feedback measures are added to the standard treatment: Outcome Rating Scale (ORS) and Group Session Rating Scale (GSRS). The ORS assesses areas of life functioning known to change as a result of therapeutic intervention. The GSRS assesses key dimensions of effective therapeutic relationships.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or older.
* BMI of minimum 20.
* Meet the diagnostic criteria for Bulimia Nervosa, Binge Eating Disorder or EDNOS according to DSM- IV.

Exclusion Criteria:

* Acute suicidal risk.
* Psychosis.
* Severe depression.
* Abuse of alcohol, medicine and/or narcotics up to 3 months before referral.
* Use of cannabis once a month is accepted at intake but must stop during treatment.
* Concomitant psychotherapeutic/ psychiatric treatment outside Stolpegaard Psychotherapy Centre.
* Severe or non-regulated physical co-morbidity.
* Pregnancy.
* Unable to understand Danish.
* Previous participation in the current trial.
* Considered unable to attend treatment sessions as planned.
* Lack of informed consent.
What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation?

This randomized study was designed to compare the 2 year clinical and functional results with the STARR procedure using a new curved cutter stapler or the same operation done with 2 traditional circular staplers.

From January to November 2006, 80 women were selected, with clinical examination, constipation score, colonoscopy, anorectal manometry, and perineography and randomly assigned to 2 groups: 40 patients underwent stapled transanal rectal resection with two staplers PPH-01 (Ethicon Endosurgery Inc, Pomezia, Italy) (STARR group) and 40 had the same operation with new, curved multi-fire stapler Contour R Transtar TM (TRANSTAR group). Patients were followed up with clinical examination, constipation score, and perineography.

Eligibility Criteria:
Inclusion Criteria:

* Rectal prolapse
* Rectocele
* ODS score \> 15
* Continence score \< 3
* Resting pressure \> 40 mm/Hg

Exclusion Criteria:

* Previous anorectal surgery
* Ods score \< 15
* Continence score \> 3
* Resting pressure \< 40
* Concomitant pelvic floor diseases
* Psychiatric diseases
* Absolute contraindications to surgery
DBS Frequency on Swallowing Function in Parkinson's Disease

The stimulation frequency has been found to affect the axial symptoms of freezing of gait (FOG) and speech in advanced Parkinson's disease (PD) patients with subthalamic nucleus deep brain stimulation (STN DBS), with the traditionally high stimulation frequency of 130 Hz worsening while low frequency of 60 Hz improving these symptoms. The effect of stimulation frequency on another important axial symptom, swallowing dysfunction, has not been studied. The investigators hypothesize that stimulation frequency could have similar effect on swallowing function.

This is the first study on the effect of the stimulation frequency on swallowing function in PD patients with STN DBS. Swallowing dysfunction is often difficult to treat pharmacologically and associated with increased morbidity and mortality. This study hence would have significant clinical implications in the management of swallowing dysfunction in these PD patients with STN DBS and could potentially decrease their morbidity and mortality.

The investigators expect that the traditionally high frequency stimulation of 130 Hz would worsen while the low frequency stimulation of 60 Hz would improve the swallowing function in OPMS summary

Eligibility Criteria:
Inclusion Criteria:

* Eight PD patients with STN DBS and freezing of gait responsive to stimulation frequency changes will be enrolled.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria
A Physical Activity Program in End-state Liver Disease

The primary aim of this study is to improve both physical fitness and sarcopenia of patients with ESLD who are potentially eligible for liver transplantation through a 12-week physical training program. Secondary aims will focus on changes in anthropometrics, body composition, quality of life, and metabolic profile. This is a randomized clinical trial including 50 patients, with half allocated to the active group (physical training program) and half to standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 70.
* Cirrhosis, any cause, defined as:

  * Biopsy-proven.
  * Two or more of the following: albumin \<3.5 g/dL, International Normalized Ration (INR) \>1.3, radiologic or endoscopic evidence of portal hypertension.
* Creatinine \<2.0 mg/dL.
* Physiologic Model for End Stage Liver Disease (MELD) ≥10.
* Decompensated cirrhosis with active or history of variceal bleeding, ascites, hepatic encephalopathy, or jaundice.
* Potential transplant candidate as per UAMS criteria

Exclusion Criteria:

* Large gastric or esophageal varices with contraindication to use beta-blockers.
* Persistent hepatic encephalopathy grades 2-4.
* Prior diagnosis of hepatocellular carcinoma, or hepatic hydrothorax (with prior repeated thoracocentesis).
* Cirrhotic cardiomyopathy or congestive heart failure, pulmonary vascular complications, known active coronary artery disease, syncope, and cardiac dysrhythmias.
* Physical impediment to perform a cardiorespiratory fitness test.
* Use of implantable defibrillator or a pacemaker.
Effects of Kinesio Taping on Performance

This study investigated the immediate effects of Kinesio taping on muscular power, strength, endurance, and lower limb fatigue when taping is applied to rectus femoris and around the patella of obese adults based on Kinesio taping techniques.

This is a randomized, double-blind, crossover, and clinical trial. Ethical approval was obtained from the University's Institutional Review Board (#2015-51). Participants were recruited by flyers posted on the University campus. Informed consent was completed by all participants prior to the study procedures. The subjects were obese college students. A total of 13 subjects, four males and nine females (mean age of 24.38 ± 3.01 years, mean percent body fat of 39.10 ± 6.91 % \[male: 41.93 ± 7.47 %, female: 38.16 ± 6.91 %\]), were enrolled this study. All subjects underwent three different trials which include no taping (NT), placebo taping (PT), and Kinesio taping (KT). All individuals were assessed for peak and mean power, muscular strength, endurance, and muscle fatigue after each condition.

Eligibility Criteria:
Inclusion Criteria:

* percent body fat of 25 % in males, 30 % in females or more

Exclusion Criteria:

* lower limb surgery within previous 6 months
* presence of any other lower limb joint diseases such as degenerative arthritis, rheumatoid arthritis.
Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis

A prospective cross-sectional study of outcomes and predictors of mortality among preterm infants with neonatal sepsis admitted in NICU of Assiut University Children's Hospital

Neonatal sepsis is a clinical syndrome of bacteremia with systemic signs and symptoms of infection in the first 28 days of life. It can also result from viral and fungal invasions of the bloodstream It is one of the events that can occur during neonatal intensive care unit (NICU) admission. It contributes significantly to the morbidity of very preterm (VP: \<32 weeks gestational age) and/or very low birthweight (VLBW: \<1500 g) infants Sepsis is a major cause of neonatal mortality and neurodevelopmental impairment among neonates which results in death and major disability for 39% of those affected even with timely antibiotic treatment .

Globally, it is estimated that more than 1.4 million neonatal deaths annually are the consequence of invasive infections .

Infection-specific mortality varies by geographic region and neonatal risk factors like gestational age and body weight .

It contributes to nearly 30-50% of neonatal deaths in developing countries . The risk of death is highest in the first 24 h of life when more than half of deaths occur and about three-quarters of all neonatal deaths occur within the first week of life.

Eligibility Criteria:
Inclusion Criteria:

* All preterm infants (\<37 weeks) diagnosed with neonatal sepsis
* Preterm infants aged 0-28 days

Exclusion Criteria:

* Full term infants (\> 37 weeks gestation) -Neonates with congenital anomalies -Neonates diagnosed with metabolic diseases
* Neonates with birth asphyxia
Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker - Phase III Non CTIMP Trial

Open to patients undergoing any pre-operative treatment for locally advanced rectal cancer, TRIGGER is the only phase III clinical trial in the UK offering watch and wait. All patients will have post treatment MRI scans routinely performed, no change from the MERCURY trials high resolution MRI protocol is required. Patients will be randomised to either the control arm for management according to national guidelines - conventional MDT, clinical assessment post-treatment planning using the baseline MRI. Patients in the interventional arm will have their post treatment MRI scans read by a radiologist trained and supported to reliably report the mrTRG grade and have their management directed accordingly - 'Good response' (mrTRG 1\&2) - watch and wait (avoidance of surgery) offered. 'Poor response' (mrTRG 3-5) - local colorectal MDT is informed and uses information to discuss and agree next steps in treatment and surveillance. Patients are followed up for five years with QoL questionnaires completed at registration, 3 and 5 years.

The only phase III clinical trial in the UK offering watch and wait, the TRIGGER trial aims to validate mrTRG as an imaging biomarker for the stratified management of patients with locally advanced rectal cancer. The 'good responders' (mrTRG1\&2) often have no evidence of tumour and it may be possible to avoid surgery in this group and so maintaining QoL while not impacting survival rates. The 'poor responders' (mrTRG3-5) are at high risk of poor oncological outcomes and this knowledge is useful in planning ongoing treatment and surveillance.

TRIGGER is now a non-cTIMP trial as the protocol does not specify chemotherapy or IMP treatments. Decisions about the use of chemotherapy will be based upon local MDT discussions as is normal practice and national policy and the trial CRFs will capture these decisions and whether more treatment is given to patients or not. TRIGGER does not mandate or recommend the use of any treatments: specifically it does not suggest the use of investigational medicinal products. If any centre wishes to use IMPs this would be in the context of separate trial protocols and would not preclude entry into TRIGGER.

Eligibility Criteria:
Inclusion Criteria:

1. MRI defined locally advanced rectal carcinoma i.e. one or more: greater than or equal to mrT3c; mrEMVI positive; mr N1c; mr CRM positive
2. Biopsy confirmed adenocarcinoma of radiologically defined rectum
3. Be deemed to require preoperative chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT)

Exclusion Criteria:

1. Metastatic disease
2. MRI, radiotherapy and/or chemotherapy contraindications
3. A post-treatment MRI performed more than 10 weeks after the completion of radiotherapy if given
4. Previous malignancy within preceding 5 years if risk of recurrence \>5%
Trial of Chinese Prescription on Ulcerative Colitis

The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription on Ulcerative Colitis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ulcerative colitis
* Male of female patients between 18-65 years old
* Written informed consent

Exclusion Criteria:

* Combine with malignant pathology on epithelial dysplasia of mucosa
* Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
* Pregnancy or breast feeding women, or unwilling to have contraception.
Ultrasound Guided Microwave Ablation of Splenomegaly in Children

Children with liver cirrhosis frequently develops portal hypertension. One of the serious complications to portal hypertension is splenomegaly, which may result in pancytopenia, especially thrombocytopenia that may cause bleeding tendencies.

Symptomatic splenomegaly is often treated with partial splenic embolization (PSE). PSE is effective but may give rise to postembolization syndrome not well tolerated in the pediatric population. In adults, microwave ablation (MWA) has been used to treat splenomegaly with promising results but with less post-operative pain. Our study is a pilot trial to evaluate the feasibility and acceptability of this treatment in children.

The ablation will be performed under general anesthesia by an experienced interventional radiologist. Ultrasound will be used for peri-operative assessment and the microwave antenna will be inserted under ultrasound guidance focusing on the middle to inferior part of the spleen to avoid harm to the diaphragm. After the emission of microwaves for up to 5 minutes, the antenna will be pulled back and the emission will be repeated until the ablation zone is approximately 1 cm from the splenic surface. In this way, two or three overlapping areas will be ablated with every insertion of the antenna. The ablation zones will be visible as hyperechoic areas on b-mode ultrasound during operation, and the goal is to ablate up to 40-50% of the total volume of the spleen (as estimated by the radiologist). If the ablated volume is less than 40-50% at follow up, the procedure can be repeated in a second session for additional effect.

Eligibility Criteria:
Inclusion Criteria:

* Spleen length \> +2 standard deviations of normal limit
* Platelet count below 30-35 x 109 cells/L and a history of bleeding tendencies
* Symptoms of portal hypertension such as splenomegaly, thrombocytopenia, leucopenia, ascites, esophageal or gastric varices, hypertensive gastropathy, anal hemorrhoids and increased portal scintigraphy index, where alternative methods have not been enough or suitable
* A necessity for reduction of splenic volume due to splenic inhibition of motion and activity in the child

Exclusion Criteria:

* Age younger than 10 or older than 17 years of age
* Legal guardians or child do not give consent
* Ongoing infection
Phase II Trial of BrECADD in HIV-Positive Patients With Advanced-Stage Classical Hodgkin Lymphoma

Participants receive chemotherapy with BrECADD in standard doses and cycle length. After the first two cycles, a restaging is performed by contrast-enhanced computed tomography (ceCT) and PET (PET/CT) in order to guide response-adapted continuation of therapy consisting of 4 or only 2 additional cycles of BrECADD in case of a PET-positive or -negative staging result, respectively. A second restaging will be performed after completion of chemotherapy. In patients with PET-positive residual disease, local irradiation followed by another restaging is recommended. ART should be continued during chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed first diagnosis of cHL
* Advanced-stage disease: stage IIB with large mediastinal mass and/or extranodal lesions or stage III or IV
* No previous treatment for HL with the exception of steroid prephase
* Confirmed HIV infection with CD4 counts ≥ 150/μL at registration or \> 250/μL at any time within 8 months prior to HL diagnosis
* Continuation of antiretroviral treatment (ART) / Initiation of ART in patients who are ART-naive
* Age: 18-60 years

Exclusion Criteria:

* Previous malignancy during last 5 years or active malignancy, prior chemotherapy or radiotherapy which precludes protocol treatment
* Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
* Multi-drug resistant HIV infection or concurrent AIDS-defining conditions
* Pregnancy or breastfeeding
Erector Spinae Block Versus Caudal Block for Perioperative Analgesia in Pediatric Cancer Patients

The study aim to compare ultrasound guided erector spinae plane block versus ultrasound guided caudal block in perioperative analgesia for pediatric cancer patients


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II
* Age \>1 and \<12
* patients undergoing nephrectomy surgeries

Exclusion Criteria:

* patients parental refusal
* local infection at the puncture site
* coagulopathy with INR\> 1.6
* unstable cardiovascular disease
* patients allergic to medication used
* development or mental delay
* impaired liver and renal functions
Upfront Surgical Resection for Osteosarcoma

The goal of this pilot study is to learn about patients with newly diagnosed osteosarcoma of an extremity, and whether surgically removing the tumor prior to the administration of any chemotherapy will improve functional outcomes. In order to learn about the patient's experience, the study team will administer questionnaires to the patient and surgeon at various timepoints to assess recovery and the function of the extremity.

This prospective, non-randomized pilot study will assess patient-reported functional outcomes of upfront surgical resection in patients with newly diagnosed, biopsy-proven, localized osteosarcoma of the extremity or the pelvis. Following biopsy, all patients will undergo wide excision of the tumor followed by systemic multi-agent cytotoxic chemotherapy consisting of a regimen at least equivalent to the standard of care of high dose Methotrexate, Doxorubicin, and Cisplatin (MAP). Patients and/or their parent/guardian will be administered PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaires, while surgeons will be administered the Musculoskeletal Tumor Society (MSTS) questionnaire at various timepoints through the first year post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have newly diagnosed, previously untreated, localized, high-grade osteosarcoma of an extremity (verified by histopathology) with plans to undergo upfront surgical resection of the tumor followed by systemic chemotherapy.
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2 (Karnofsky will be used for patients \>16 years of age and Lansky score for patients \<= 16 years of age)

Exclusion Criteria:

* Patients with metastatic disease at diagnosis
* Initiation of systemic therapy prior to enrollment
* Prior history of cancer
* Prior radiation therapy
* Active life-threatening infection
* Pregnancy (negative pregnancy test result must be obtained for female patients of childbearing potential)
Liver Cancer Community Education

This study proposes to bridge the gap between evidence and action and combat rising liver cancer rates attributed to Hepatitis B and C infection in Philadelphia by identifying neighborhoods with higher than expected rates of liver cancer and related risk factors and administering an educational intervention about liver cancer and neighborhood health in those communities, working with existing community partners at Fox Chase Cancer Center.


Eligibility Criteria:
Inclusion Criteria:

* Speaks/reads English
* Lives in Philadelphia or receives healthcare at a community partner site in Philadelphia

Exclusion Criteria:

* None
Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B in Perimenopausal Women.

To evaluate effectiveness and safety of combined use of dietary supplements Amberen and Smart B in women with a typical (without complications) form of climacteric syndrome, with mild to moderate symptoms in perimenopause.

1. To evaluate effectiveness of combined use of dietary supplements Amberen and Smart B in women vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause.
2. To evaluate safety of combined use of dietary supplements Amberen and Smart B in women with vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause.
3. To develop recommendations for combined use of dietary supplements Amberen and Smart B for women with vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects, 50 years of age or younger;

  * Subjects in the second phase of menopausal transition as per STRAW 10+ i.e. interval of amenorrhea 60 days or more (with regular menstrual cycle during earlier reproductive stages).
  * Subjects with diagnosis of mild to moderate climacteric syndrome;
  * Recent (up to 12 months prior to study enrollment) breast exam results, including mammogram, that rule out malignancies;
  * Recent (up to 3 years prior to study enrollment) cytological screening that rules out vaginal cervix malignancies.
  * Ability to read and understand informed consent form for the study's participation;
  * Ability to adhere to the conditions of the study.

Exclusion Criteria:

* • Postmenopause, including surgical menopause.

  * Presence of hormone-dependent cancers;
  * Presence of other cancers, not in full remission with no recurrence for 5 years or more;
  * Planned hospitalization in the next 6 months;
  * Presence of hormonally-active extragenital endocrine diseases (diabetes; diseases of thyroid, adrenal, pituitary) that require prolonged or life-long therapies
  * Surgical interventions on sex organs or breasts, 1 year or less prior to the screening;
  * Gynecological conditions that may require hormonal therapies or surgeries (uterine myoma, endometriosis, endometrial hyperplasia etc.);
  * Currently undergoing or planning to utilize assisted reproductive technologies;
  * Any abdominal surgeries within less than 3 months prior to the screening;
  * HRT including MHRT or hormonal contraceptives - current or within less than 3 months prior to the screening;
  * Psychiatric conditions;
  * Patients taking any other dietary supplements that can affect climacteric syndrome within the last month before enrolling in the trial;
  * High risk of non-compliance.