cyrilzakka/clinical-trials huggingface dataset:
A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer

This was an open-labeled, multi-center, prospective, non-comparative study of the safety of Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who had previously received antracycline therapy before or after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Female patients \> or = 18 years of age
* Human Epidermal Growth Factor Receptor 2 (HER2)-neu overexpression
* Previously treated with adjuvant antracycline containing chemotherapy
* Left Ventricular Ejection Fraction (LVEF) \> 50%
* Eastern Cooperative Oncology Group (ECOG) score \< or = 2
* Life expectancy \> or = 12 weeks

Exclusion Criteria:

* Left Ventricular Ejection Fraction (LVEF) \< 50%
* Advanced pulmonary disease
* Severe dyspnea
* Abnormal laboratory results within 14 days prior to registration
* Peripheral neuropathy
* Presence of Central Nervous System (CNS) metastasis
Effects of Short-intensity Modified Constraint-induced Movement Therapy on Hand Function in Stroke Patients.

To determine effects of short-intensity modified constraint-induced movement therapy on hand function in stroke patients.

The aim of the study is to determine the effects of a short-intensity modified CIMT (mCIMT) program on hand function in stroke patients. This study will be a randomized controlled trial comprising two groups, an experimental group in which patients will be given short-intensity mCIMT along with conventional therapy. A control group, in which participants will be given conventional therapy alone. Patients will be assessed with the Wolf Motor Function Test, the Motor Activity Log, and the Ashworth Scale before and after treatment. The data will be analyzed by using SPSS for windows software version 25. Statistical significance will be set at p=0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients having the First stroke either ischemic or hemorrhagic (3-24 months after stroke)
* Patients having Mini-mental status examination score (MMSE) ≤23/30
* Patients having Passive range of motion (PROM) includes at least 90 degrees shoulder flexion and abduction, 45degrees shoulder external rotation,- 30 degrees elbow extension, and 45 degrees forearm supination and pronation (from a neutral position). At least 10 degrees active wrist extension, 10 degrees abduction/thumb extension, and 10-degree extension at the level of the metacarpophalangeal and interphalangeal joints between the two toes among the II-III-IV-V fingers (these movements will be repeated starting from a resting position 3 times in 1 minute).

Exclusion Criteria:

* Patients having Subarachnoid hemorrhage.
* Patients having Motor activity log - the amount of use score ≥2.5
* Patients having treatment of upper limb spasticity (e.g., botulinum toxin) in the 3 months prior to the start of the study and/or during its execution.
Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer

The investigators want to have a collection of fresh primary or recurrent tumor tissue for establishment of patients-derived xenografts in order to:

generate a biobank of in vivo patient xenografts representing the different subgroups of tumors for head and neck cancer

* perform genetic and transcriptional profiling of the primary, metastatic tumors and xenograft tumors
* evaluate the efficacy of new targeted agents, whether or not in combination with standard treatment options
* evaluate biomarkers of drug sensitivity
* study primary and secondary (acquired) resistance in these models


Eligibility Criteria:
Inclusion Criteria:

* In the first phase, all patients with primary or recurrent/ metastatic disease of head and neck cancer can be included pre-operatively or before a tumor biopsy after obtaining informed consent
* Data on stage, grade, histology, adjuvant treatment, responses, relapse should be available
* Follow-up data should be available
* Patients with recurrent disease are allowed
* Written informed consent
Postoperative Pain After Colorectal Surgery

This study aimed to evaluate pain after elective colorectal surgery and to identify risk factors for postoperative pain.

Patients:All elective colorectal surgeries at the department of surgery, Umeå university Hospital, Umeå, Sweden from March 2013 to April 2017

Primary outcome:The primary outcome measurement is the numeric rating scale (NRS), graded from 0-10, on day of surgery, postoperative (POD) 1, 2, 3. The patients are questioned by nurses each morning on four postoperative days to score the maximum pain during the previous 24 hours using the NRS.

This study aimed to quantify pain after elective colorectal surgery and to identify risk factors for postoperative pain.

Patients: This prospective cohort study includes all consecutive patients undergoing elective colorectal surgery at Umeå University Hospital in Sweden between March 2013 and April 2017.

Exclusion criteria: Patients who do not score pain at any of 4 postoperative days.

Primary outcome:The primary outcome measurement is the Numeric rating scale (NRS), graded from 0-10, where 0 = no pain and 10 = the worst imaginable pain \[18\]. Moderate pain is defined as NRS 4-6 and severe pain as NRS 7-10. The patients are questioned by nurses each morning after day of surgery, postoperative day. 1, postoperative day 2 and postoperative day 3 to score the maximum pain during the previous 24 hours using the NRS.

All data are registered in Enhanced recovery after surgery database (EISA)

Clinical variables: Baseline clinical variables are assessed preoperatively. They included age, gender, body mass index (BMI), smoking, a diabetes mellitus diagnosis and American Society of Anesthesia (ASA) class. The postoperative course is registered prospectively in Enhanced recovery after surgery register (EIAS) and include preoperative oncological treatment, a histopathologically verified cancer diagnosis, the length of hospital stay and complications, including any complication, Clavien-Dindo 3b or more and anastomotic leakage within 30 days after surgery High-sensitivity C-reactive protein (CRP) is measured every postoperative morning.

Eligibility Criteria:
Inclusion Criteria: Consecutive adults undergoing elective open and minimally invasive colorectal surgery at the Department of Surgery, Umeå University Hospital, from March 2013 to April 2017

Exclusion Criteria: Patients not scoring pain at any of 4 postoperative days.
Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate

Orofacial clefts are the second most common birth deformity and vary in etiology and phenotype, e.g. isolated cleft palate, cleft lip or cleft lip palate. Especially newborns with unilateral complete cleft lip and palate (UCLP) present severe facial asymmetries auch as a broad and flat ala of the nose, a deviation of the columella and the philtrum to the non cleft side. Since postnatal asymmetries can even remain after surgical lip closure in a alleviated shape, therapeutic presurgical orthodontic approaches to improve symmetrie of the nose and to achieve ideal conditions for lip surgery are essential.

Presurgical orthodontic treatment for newborns with UCLP start within the first days after birth to separate oral and nasal cavitiy, to improve breathing and feeding and to regulate growth of the maxillary segments using passive appliances (passive Alveolar Molding (pAM)). An advanced and widely spread concept is the Nasoalveolar Molding (NAM) by Grayson, which was first introduced in 1993 as a palate plate combined with a nasal stent as a non-invasive presurgical appliance to stimulate growth of the nose and use the postnatal potential to modulate the nasal cartilage. The aim of the NAM therapy is to reduce nasal width, to reduce deviation of the columella to the non cleft side and to increase nostril height. However, due to inhomogeneous study designs and results, so far only a slightly positive effect using NAM therapy could be detected and prospective, randomized clinical trials are necessary.

The aim of the study is to analyse and to compare the effects of pAM versus NAM treatment in newborns with UCLP in the first year of life. The following parameters will be analysed on defined study time points: nostril width, nasal morphology, cleft width, maxillary growth, statical and dynamical facial asymmetries and facial perception.


Eligibility Criteria:
Inclusion Criteria:

* newborns/infants with non-syndromal (ns) unilateral cleft lip palate (UCLP)
* signed informed consent by the parents or legal guardian

Exclusion Criteria:

* newborns/infants with syndromal (s) unilateral cleft lip palate (UCLP)
* insufficient adherence and compliance by the parents or legal guardian
* withdrawal of informed consent by the parents or legal guardian
Intestinal Microbiota Impact for Prognosis and Treatment Outcomes in Early Luminal Breast Cancer and Pancreatic Cancer Patients

The gut microbiota (GM) can influence as effectiveness of immunotherapy as prognosis factor in cancer patients. The goal of the study to identify GM pattern is associated with poor and favourable treatment outcomes in breast cancer and pancreatic cancer patients for further treatment strategy proper planning.


Eligibility Criteria:
Inclusion Criteria:

* untreated early HR+ HER2- BC:

  1. planned neoadjuvant chemotherapy: dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
  2. TanyN1-3M0 Ki67\>40% G3
  3. ECOG 0-1
* untreated early HR+ HER2- BC:

  1. TanyN0M0 Ki67\<20% G1
  2. ECOG 0-1
  3. planned induction endocrine therapy (letrozole/anastrazole/tamoxifen)
* untreated locally-advanced and/or borderline resectable pancreas cancer:

  1. planned (neo)adjuvant chemotherapy: mFOLFIRINOX
  2. previous surgery ( only R0 resection) is allowed
  3. ECOG 0-1
  4. histology diagnosis verification
* Informed consent
* Eligible blood\&fecal samples and tumor tissue for different time points

Exclusion Criteria:

* autoimmune disease
* active steroid therapy
* ECOG \> 2
* any previous therapy for breast cancer
* metastatic cancer
* antibiotic use less than 28 days
* other tumor
Closure of Protective Ileostomy 2 vs. 12 Weeks After TME

The purpose of this study is to compare the feasibility, safety, and quality of life (QOL) in patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12 weeks.

In three surgical departments between 2007 and 2013, 72 pts with total mesorectal excision and coloanal or low colorectal anastomosis for rectal cancer were randomly assigned to closure of their protective ileostomy after 2 weeks (group A, 37 pts) or 12 weeks (group B, 35 pts). One day before planned stoma closure, the coloanal/colorectal anastomosis was checked by palpation, contrast enema via ileostomy and, in case of hazards, by proctoscopy. Perioperative data was assessed prospectively using numeric values, visual analogue scales (VAS, 0 = lowest value, 100 = highest value) and QOL-index (GQLI, max. 144 points). Complications were recorded prospectively.

Eligibility Criteria:
Inclusion Criteria:

* anastomosis ≤ 5cm from anal verge
* age \>18 years
* informed consent
* uneventful course after first operation

Exclusion Criteria:

* pregnancy
* allergy to contrast agent
* severe non-surgical complications
* evident abdominal - pelvic complications
Biomedical Research Informatics Centre for Cardiovascular Sciences (The BRICCS Study)

This project will examine the diagnosis and prognosis of patients with cardiovascular disease in hospital in- and outpatients and compare their characteristics with normal controls from the community. The cardiovascular diseases studied include coronary artery disease, heart failure, heart attacks, valve disease, cardiac surgery, dysrhythmias, aneurysms, embolism, strokes, peripheral vascular disease and hypertension. Current methods for diagnosis and predicting outcome in patients are limited and may lack accuracy. This study will collect clinical details, and blood and urine samples from patients for analysis of proteins, chemicals and genetic biomarkers which will enable an examination of the pathological mechanisms involved in cardiovascular disease. The data will also be used to improve diagnosis and also improve prediction of outcome in patients (future clinical events such as death, further hospitalisation with cardiovascular disease and the effects of any therapy given to the patients). In this way, we can develop accurate ways of assessing a patient's condition and how it could be effectively managed. The study will last for 20 years.


Eligibility Criteria:
Inclusion Criteria:

* All outpatients and inpatients with cardiovascular disease, of either gender
* Aged 18-90 years old
* Examples of conditions include: coronary artery disease, heart failure, heart attacks (myocardial infarction), valve disease, cardiac surgery, dysrhythmias (including atrial fibrillation), aneurysms, embolism, strokes, peripheral vascular disease, hypertension (and its complications, such as left ventricular hypertrophy) or those presenting with chest pain
* Healthy volunteers
* Aged 18-90 years old
* From the community without cardiovascular or other diseases

Exclusion Criteria:

* Any patient who is unable to give consent
* Any patient with non-cardiovascular comorbidity likely to cause death within 6 months
* Patients know to be infected with HIV, Hepatitis B or any other agent posing an infection risk from unfixed material
An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C

The purpose of this open-label, non-randomized, single-arm, multicentre observational study is to investigate the influence of the cumulative dose (total administered dose/ planned dose) of ribavirin on the sustained virologic response (SVR) in participants who have been receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus).


Eligibility Criteria:
Inclusion Criteria:

* Participants with serologically confirmed chronic hepatitis C
* Participants using and accepting a double method of contraception

Exclusion Criteria:

* Participants not approved by the national treatment guideline or the Interferon Committee for combined pegylated interferon-ribavirin treatment
* Contraindications in the summary of product characteristics of pegylated interferon alpha-2a and ribavirin
* Participants previously treated with pegylated interferon and/or ribavirin
* Hepatitis B and Human Immunodeficiency Virus co-infections
Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum

The purpose of this study is to determine whether vilobelimab (development name: IFX-1) is safe and effective in the treatment of pyoderma gangrenosum.

Neutrophilic dermatoses are a spectrum of inflammatory disorders characterized by skin lesions resulting from a neutrophil-rich inflammatory infiltrate in the absence of infection. Pyoderma gangrenosum is associated with a neutrophilic leukocytosis, which is likely to be triggered by C5a. This study is set up based on the hypothesis that vilobelimab might be able to block C5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator

In addition, the subject must fulfill at least 3 of the following 6 criteria at screening:

History of

* Pathergy (ulcer occurring at the sites of trauma)
* Personal history of inflammatory bowel disease or inflammatory arthritis
* History of papule, pustule or vesicle that rapidly ulcerated

Clinical examination (or photographic evidence) of

* Peripheral erythema, undermining border, and tenderness at site of ulceration
* Multiple ulcerations (at least 1 occurring on the lower leg)
* Cribriform or "wrinkled paper" scar(s) at sites of healed ulcers

Subject has a minimum of 1 evaluable ulcer (≥2 cm2) on the lower extremity at screening

Exclusion Criteria:

* Pyoderma gangrenosum target ulcer for more than 3 years before screening
* Surgical wound debridement within the previous 2 weeks before screening
* Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days before screening
* Any drug treatment for pyoderma gangrenosum including corticosteroids (\>10 mg), intralesional steroids, cyclosporine A, biologicals and immunosuppressives (with the exception of antibiotics for wound superinfection) used within a time of 5 half-lives of the drug before screening
Estimating Blood [Lactate] Non-Invasively

The purpose of this study is to validate the LabClasp's ability to estimate blood \[lactate\].


Eligibility Criteria:
Inclusion Criteria - Aim 1:

* Subjects must be able to provide written consent.
* Adults 18 years of age and older.
* Nonsmokers.
* No recent hospitalization (\< 60 days).
* Ability to perform high-intensity exercise.

Inclusion Criteria - Aim 2:

* Subjects must be able to provide written consent to be included in the research study.
* Adults 18 years of age and older.
* Nonsmokers.
* Current ICU patient.
* Have regular blood samples taken for \[lactate\] measurements.
* Have one or more risk factors for sepsis.

Exclusion Criteria - Aims 1 and 2:

* History of, or active malignancy.
* History of HIV with antiretroviral treatment.
* Smokers.
* Pregnancy.
Transplantation With Ybritumomab Tiuxetan (Zevalin) Plus BEAM Regimen in Patients With Refractory Large B-cell Difusse Lymphom

To evaluate the efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin) administration in the conditioning treatment of patients with refractory large B-cell diffuse lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem cells.


Eligibility Criteria:
Inclusion Criteria:

1. Give their written informed consent.
2. Abide by at least one of the following conditions:

   * Obtain no partial response after first-line chemotherapy including anthracyclines + rituximab (R-CHOP, R-MegaCHOP, R-EPOCH or the like), or else
   * Absence of partial response after having received salvage (post-induction) chemotherapy including R-IFE, R-ESHAP, R-ICE or the like.
   * Patients on first recidivation who do not attain partial remission after salvage chemotherapy.
   * Patients with transformed lymphoma, on first partial remission (No CR).
3. Stable disease at the time of transplantation.
4. Age ≥ 18 but ≤ 70.
5. Life expectancy of greater than three months.

Additionally, to be able to undergo haematopoietic stem cell transplantation, all patients should satisfy the requirements of routine clinical practice, i.e.:

1. Performance status (ECOG) \< 3.
2. FEV1, DLCO and FVC ≥ 50% of the normal theoretical values.
3. Ventricular ejection fraction (through echocardiography or isotope ventriculography) ≥ 50%.
4. Total bilirubin and transaminases \< 3 times the normal maximum value, except if attributable to the underlying disease.
5. Creatinine \< 2 times the maximum normal value, and creatinine clearance \> 40 ml/min, except if attributable to the underlying disease.
6. Absence of symptomatic heart disease, cirrhosis or active B or C virus hepatitis.
7. HIV negative.

Exclusion Criteria:

1. Impossibility of collecting, via apheresis, a number of CD34+ cells ≥ 2 x 106/kg.
2. Known hypersensitivity to mouse proteins.
3. Involvement of CNS by lymphoma.
4. Progressive lymphoma during the month prior to the date of transplantation.
5. Previous radioimmunotherapy.
6. Previous autologous transplantation of haematopoietic stem cells.
7. Pregnant or breastfeeding women, or adults of childbearing age who are not using an effective contraceptive method.
8. Being submitted to treatment in a clinical trial for 30 days prior to entry in this trial.
9. Active psychiatric disease, including addiction disorders.
10. Existence of active not-haematopoietic neoplasia, with the exception of cutaneous basal carcinoma or cervix intraepithelial carcinoma.
Surgical Evacuation of Abortion Under Ultrasonographic Guide

Abortion is considered the most common cause of fetal demise all over the world. The majority of cases occur in the first trimester. The termination of abortion may be by medical or surgical methods, however; the surgical methods represent the greater part of termination. Therefore, the safety of this procedure is a worldwide public health concern. Many clinical studies have reported the safety of surgical evacuation in the first trimester.

The suction-aspiration or vacuum aspiration is the most common surgical method of induced abortion. This consists of removing the fetus, embryo, placenta, and membranes by suction using a manual syringe or electric pump. However; these techniques always need cervical dilation before aspiration. The menstrual extraction does not require cervical dilation and can be used in very early pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* women with non-viable first trimester intrauterine pregnancy
* no contraindication to surgical evacuation under general anesthesia

Exclusion Criteria:

* gestational age more than 13 weeks
* hemodynamically unstable
* suspicion of an ectopic pregnancy
A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy

Primary Objective: To evaluate the efficacy of SKL11197 for the treatment of diabetic peripheral neuropathy pain (DPN).

Secondary Objective: To evaluate the safety and tolerability of SKL11197 in subjects with painful diabetic peripheral neuropathy.

Primary Efficacy Endpoint: The primary efficacy outcome variable will be the time to exit from the double-blind phase because of inadequate pain relief.

This study is a double-blind, placebo controlled study with three phases;

1. a pre-study medication washout/screening phase upto 3 weeks
2. a 3-week, open label phase
3. a 6-week double-blind phase At the end of 3-week in the open label phase, subjects may enter the double-blind phase if they meet the eligibility criteria.

Eligible subjects will be randomized in a blinded fashion either to continue with SKL11197 at 300 mg TID or to take the same number of placebo capsules.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
3. At least moderate pain, ≥ 40mm on a 100mm VAS at the end of washout phase (in absence of any analgesic);
4. HbA1c \< 12 % at Screening
5. Daily pain attributed to diabetic neuropathy for least 3 months prior to Screening on the basis of history and physical examination documenting peripheral neuropathy.
6. Pain from diabetic neuropathy should be identifiable by the subject. Pain must involve the lower extremities and be bilateral.
7. Females must be of non-childbearing potential (defined as either surgically sterile or at least one year postmenopausal, Menopause is defined as 1 year since last menstrual period with associated subjective sensations), or,
8. If capable of bearing children, females must use a double-barrier method of contraception, or an intrauterine device. Females capable of bearing children must have negative serum pregnancy (beta-HCG) test at Screening and negative urine pregnancy on Day 1.

Exclusion Criteria:

1. Pregnant or lactating females
2. Subjects with BMI over 40
3. Pain due to symptomatic peripheral vascular disease (e.g. intermittent claudication)
4. Subjects with known clinically significant decreased blood flow to the extremities
5. Subjects cannot have pain from other sources that can confuse the assessment of the diabetic neuropathic pain
6. Peripheral neuropathy attributable to other causes such as alcoholism, connective tissue disease, or toxic exposure;
7. Have profound autonomic dysfunction, or brittle diabetes;
8. Evidence of amputations (including toes), open ulcers, or Charcot joint.