cyrilzakka/clinical-trials huggingface dataset:
Aggressive Acts Among Patients With Schizophrenia

The purpose of this series of study has a many-fold intention depicted as follows: to describe and characterize schizophrenic patients' aggressive acts in hospital and community, to identify and specify heterogeneity in their structure, and to look for and set up risk factors for prevention. This study investigates four major issues: (1) Establishing an objective behavior rating scale for measuring aggressive acts; (2) Understanding the characteristics and incidence of aggressive acts by patients with schizophrenia; (3) Exploration of the heterogeneous structure of aggressive acts by patients with schizophrenia; and (4) Identifying the risk factors of aggressive acts of patients with schizophrenia.

Psychiatric patients' aggressive acts can occur frequently and are recognized as a significant problem in psychiatric services. Understanding of aggressive acts in clinical settings and community is still incomplete and the clinical care of aggressive acts remains unsatisfactory. This study investigates four major issues: (1) Establishing an objective behavior rating scale for measuring aggressive acts; (2) Understanding the characteristics and incidence of aggressive acts by patients with schizophrenia; (3) Exploration of the heterogeneous structure of aggressive acts by patients with schizophrenia; and (4) Identifying the risk factors of aggressive acts of patients with schizophrenia. At first, the content validity, construct validity, and internal consistency of the Chinese version of Violence Scale were examined. Both of retrospective survey and prospective panel design were used for data collection. Patients fulfilling the DSM-IV criteria of schizophrenia in hospital and community, and their siblings and family caregivers, were recruited as different phases of study subjects, after signing informed consent for understanding their past history, prospective occurrence of aggressive acts, and the related risk factors. It is therefore to establish objective measures and to develop insights into the heterogeneity and related risk factors of aggressive acts, for improvement in the management and prevention of aggressive acts.

Eligibility Criteria:
Inclusion Criteria:

Patients with clinical diagnosis of schizophrenia spectrum, fulfilling the diagnostic criteria of the 4th version of Diagnostic and Statistical Manual (DSM-IV)(APA, 1994)were recruited as study subjects, after signing informed consent. Their families, including their siblings and family caregivers, were also recruited in the study.

Exclusion Criteria:

Exclusion criteria of the patient samples include co-mobility with mental retardation, personality disorder, organic brain disorders, and alcohol or substance abuse/ dependence.
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Testicular Injury and Oligospermia

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Testicular Injury and Oligospermia

This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Testicular Injury and Oligospermia. Patients will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Testicular Injury or Oligospermia
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Previous organ transplant
* Hypersensitivity to sulfur
Trial of Primary Prophylaxis With rhTPO Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy

Intensive chemotherapy is often associated with low platelet counts often requiring platelet transfusions to maintain platelet counts. In previous clinical studies administration of rhTPO has been demonstrated to increase platelet counts.

To evaluate the effectiveness of intravenous rhTPO vs. placebo as primary prophylaxis in reducing the cumulative proportion of patients requiring platelet transfusion for severe chemotherapy-induced thrombocytopenia (platelet count \<15,000) during the first four study cycles. To evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis, the impact of rhTPO prophylaxis on health economics/cost effectiveness, and patient quality of life. To assess the safety of multiple IV doses of rhTPO.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed new diagnosis of moderate or high-grade sarcoma (except leiomyosarcoma of gastrointestinal origin)
* Must have high risk disease by American Joint Committee on Cancer (AJCC) Staging System Stage IIC, III, or IV
* Must have recovered from surgery for a minimum of 2 weeks
* Must be scheduled for a minimum of 4 cycles of AI therapy
* Must be 13 years or older
* Must have ECOG performance status of 0, 1, or 2.
* Must have life expectancy of at least 12 weeks.
* Left ventricular ejection fraction must be more than 50%.
* Laboratory data within normal limits.

Exclusion Criteria:

* Prior front-line standard or experimental therapy for sarcoma
* History of bone marrow and or peripheral blood progenitor cell transplantation
* Prior pelvic radiation or radiation therapy to more than 25% of bone marrow reserves
* Prior treatment with megakaryocyte growth and differentiation factor
* Prior treatment with rhTPO
* History of platelet disorder
* History of myocardial infarction, stroke, pulmonary embolism, or deep vein thrombosis within the past 12 months
* Pregnant or lactating women
* Use of anticoagulants such as coumadin, heparin, etc.
* Known HIV or hepatitis
Guiding Aging Long-Term Opioid Therapy Users Into Safer Use Patterns

Patients on long-term opioid therapy are aging and now face magnified risk of harm with continued high-dose opioid use. These increased risks are due to age-related changes in drug metabolism, multi-morbidity, and polypharmacy. The dominant approach to mitigate these risks is to screen for aberrant patient opioid behaviors so that clinicians can pre-empt misuse early through review of contractual opioid agreements or by lowering patient dosages. By focusing on opioid misuse alone, this strategy encourages forced opioid tapering that is associated with opioid overdose and mental health crisis. Directing clinician attention to the comorbid conditions associated with opioid misuse may promote safer and more effective care.

The objective of this study is to assess the comparative effectiveness of PainTracker, a set of questions that targets a broad range of problems associated with pain, in a randomized controlled trial involving 300 Northwestern Medicine clinicians treating Chronic Opioid Use Registry patients (n=5159).

Using the electronic health record, patient portal, and patient-reported outcome capabilities, the investigators will develop programming logic for a randomized experimentation platform wherein two or more versions of pain surveys may be delivered to patients. This system will be used to evaluate PainTracker, delivered to half of the sample (approximately 2,579 patients). Clinicians treating Chronic Opioid Use Registry patients that meet the inclusion criteria will be assigned to one of two conditions involving patient surveys: 1) Current Opioid Misuse Measure \[COMM\] \[standard clinical care\] or 2) COMM + PainTracker. Surveys will be delivered monthly and patients will be prompted 3 times to complete the survey; once completed, patients will receive a score also delivered to their physician's inbox in Epic.

Eligibility Criteria:
Inclusion Criteria:

• Patients age 65 or older on long-term opioid therapy within the Northwestern Medicine Chronic Opioid Use registry system with at least one primary care encounter in the past 12 months.

Exclusion criteria:

• Patient visits with active cancer diagnoses
Chest Shielding in Premature Infants During Phototherapy

This is a feasibility study where Infants will be randomized to either chest shielding with aluminum foil or chest shielding without aluminum foil while undergoing phototherapy for premature infants. The primary outcome is patent ductus arteriosus.


Eligibility Criteria:
Inclusion Criteria:

* less or equal to 29 weeks or 1000g at birth
* Admitted to the NICU (Neonatal intensive care unit) within 24 hours after birth
* English speaking parents

Exclusion Criteria:

* Congenital abnormalities
* Chromosomal disorders
* Cyanotic heart defects
* Nitric oxide
* Prophylactic phototherapy
* Unlikely to survive beyond 72 hours according to the attending neonatologist
* Do not require phototherapy
Hip Fractures Treated With Uncemented Arthroplasties

The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties.

The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.

Femoral neck fracture is a common cause of suffering and premature mortality among the elderly. Riskfactors for femoral neck fractures are age, gender, osteoporosis and cognitive dysfunction.

Mortality and morbidity varies between undisplaced and displaced femoral neck fractures.

Different treatment options are available: reduction and internal fixation vs joint replacement (arthroplasty). The treatment of undisplaced femoral neck fractures is uncontroversial and consists of internal fixation with screws.

The treatment of displaced, femoral neck fractures with internal fixation shows unacceptable results with complications rates leading to reoperation between 40-60%. Treatment of these fractures with arthroplasties has therefore become the standard treatment in industrial countries.

Fixation of the femoral component with bone-cement is standard procedure in Europe today. To avoid negative cardio-pulmonary events in patients with serious comorbidities and in very old and frail patients uncemented femoral components or internal fixation are used. These uncemented stems are mostly older design with poor track records. The use of modern, well-documented stems used in an osteoarthritis population for fracture patients has still to be tested.

Eligibility Criteria:
Inclusion Criteria:

* displaced fracture of the femoral neck
* independent living
* independent ambulation (with or without walking aids)

Exclusion Criteria:

* pathological fracture
* severe dementia (defined as ≤3 in short portable mental questionnaire) preoperatively
* preexisting ipsilateral hip disease
* neurological disease (e.g. M. Parkinson)
* psychiatric disease which makes understanding or following instructions impossible
* history of drug and alcohol abuse
Mutational Profiling in Colorectal Tumors to Determine Its Role in the Diagnosis, Prognostic Significance and Their Impact in Clinical Management

The aim of this study is to investigate mutational changes occurring in colorectal tumors, from benign polyps, malignant cancer and metastatic tumors. The investigators also plan to establish the clinical correlation, emphasizing on aspects such as the diagnosis and prognosis of disease and the specific treatment outcome. For the purpose, the investigators plan to obtain specimens from patients with colorectal tumors to extract DNA material. The specimens include tissues from either primary (mostly endoscopic biopsies specimens) or metastatic tumors (obtained from sonogram or other imaging modalities guided biopsy), as well as other humors including blood (for serum), malignant ascites, pleural effusions or other body fluids that could be related to CRCs. These patients would receive detailed explanations with regard to the investigations before signing IRB consent. At the initial stage, Wanfang Medical Center would be the only medical institution where endoscopic specimens would be collected. The project would eventually be extended to the Taipei Medical University Hospital and Shuan-Ho Hospital.

The following are items corresponding to the critical tasks of the project.

1. Collect, annotate, and store fresh endoscopic specimens of suspicious abnormal tissue (premalignant lesions and primary tumors for genetic mutational investigation;
2. Collect, annotate, and store fresh specimens from metastatic lesions (e.g.: hepatic metastatic tumors), under sonographic or other imaging modalities guided biopsy procedures;
3. Collect, process, and store serum, plasma and isolate lymphocytes from blood drawn from patients with colorectal tumor;
4. Establish a database to link materials acquisition, pathologic, and clinical information on patients who participate in the protocol;
5. To utilize the clinical database to perform clinical and pathological correlation with the results of current and future scientific studies;
6. To evaluate genomic and biochemical alterations in colorectal tumors.
7. To test the effect of small molecule inhibitors on the activation of wild-type and mutant genetic alterations and/or other potential molecular targets.
8. To correlate tumor genotype and signaling abnormalities with clinical response to genetic alterations and/or other potential molecular targets inhibitors
9. Analysis of laboratory findings in relationship to patient demographics and clinical course.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have been noted with a colonic tumor (benign polyps or colorectal cancer) on colonoscopy. Patients with lesions located other than the primary tumor (metastatic lesions) such as liver metastasis, enlarged lymph nodes suspicious of metastasis, malignant pleural effusion, ascites, etc. are also enrolled.
* Age 20
* Signed consent

Exclusion Criteria:

* Known HIV infection
* Known to have bleeding tendency, precluding for biopsy
* Any other clinical conditions, which, in the opinion of the principal investigator, would not allow completion of this study
Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment

The management of deep carious lesions approaching a healthy pulp is considered a challenge to the dental practitioner. The conventional treatment of deep carious lesions requires the removal of all infected and affected dentin to avoid more cariogenic activity.

This study is designed to assess the clinical and radiographic effectivness of nano silver fluoride versus calcium hydroxide in an indirect pulp treatment of deep carious second primary molars. This clinical study is important because World Health Organization (WHO) has reported that school children experience to dental caries was 60-90% of worldwide (P. D. Garkoti et al., 2015).

This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide (Metalita M et al., 2016).

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Cooperative children.
* Both genders.
* In age range from 4 to 7 years.

Teeth:

* Vital second primary molars with deep caries limited to occlusal surface.
* No clinical signs or symptoms of irreversible pulpitis or pulp necrosis.
* No radiographic abnormalities
* Restorable teeth.

Exclusion Criteria:

* • Children with known history of allergy to any of the tested materials.

  * Children with systemic conditions.
  * Parents who refused to participate.
START: Swiss Taxotere Alopecia Prevention Trial

Primary objective:

* Rate of complete chemotherapy induced alopecia (WHO grade III or IV, physician grading)

Secondary objective:

* Compliance to scalp cooling procedure
* Received number of cycles of chemotherapy in each subgroup
* Patient perception of scalp cooling procedure
* Side effects of scalp cooling systems


Eligibility Criteria:
Inclusion Criteria:

* Any solid tumor malignancy receiving docetaxel (Taxotere®) 1st line chemotherapy treatment with the exception of regimen containing concomitant anthracycline treatment; sequential anthracycline/docetaxel treatment is permitted.
* Performance Status ECOG \<= 2
* Absence of alopecia at inclusion

Exclusion Criteria:

* Chemotherapy regimen including concomitant anthracycline treatment
* Raynaud's disease or phenomenon
* Cold agglutinin disease
* Cryoglobulinemia
* Cryofibrinogenemia
* Scalp metastasis
* Pregnancy or Lactation
* Preexisting alopecia of any grade; notably androgenetic alopecia
Energy Dense Oleic Acid Formula to Geriatric Patients

Background and aims:

Old patients seldom reach energy requirements. The effects of an oleic-acid rich formula on energy intake and appetite were studied.

Methods: Recently admitted geriatric patients (n=71), likely to stay more than 1 week were randomised to receive a fat emulsion (Calogen, intervention group (IG)) or to standard care (control group (CG)). Thirty ml of the emulsion were given 3 times daily, i.e. 420 kcal, and was distributed at the regular medication rounds. Food intake and self-rated appetite were registered 2-3 days after admission and on day 8 or the day prior to discharge. Nutritional risk screening (NRS) 2002 and serum lipids and fatty acid profiles were analysed.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were: likely to stay at the ward more than one week, \>65 years old and able to give informed consent.

Exclusion Criteria:

* Exclusion criteria were: pancreatitis, fat malabsorption, overweight (BMI \>30) and non-consent for participation.
Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain

Guidelines advocate several complementary modalities as alternatives to drugs and other invasive treatments for chronic low back pain (LBP) conditions. However, there is little high-quality research investigating treatments for back-related leg pain, one of the more severe and disabling presentations of LBP. The investigators are conducting a pilot study to assess the feasibility of a future phase II multi-site randomized clinical trial (RCT). The future trial will assess the comparative effectiveness of a novel supported biopsychosocial self-management (SBSM) intervention versus Medical Care (MC).


Eligibility Criteria:
Inclusion Criteria:

* Back-related leg pain (BRLP) consistent with the Quebec Task Force (QTF) classifications 2-4 (radiating pain into proximal or distal extremity with or without neurological signs).
* 18 years of age or older.
* Back-related leg pain severity of 3 or higher at all screening assessments (0 to 10 scale)
* Episode duration of 12 weeks or more
* Ability to read English fluently

Exclusion Criteria:

* Spinal stenosis (QTF 7)
* Specific, non-mechanical causes of BRLP (QTF 11; e.g. infection, tumor)
* Contraindications to study interventions (e.g. spinal fracture (QTF 5))
* Inflammatory conditions of the lumbar spine (QTF 11)
* Lumbar fusion
* Progressive neurological deficits
* Cauda equina syndrome
* Pregnancy, nursing
* Ongoing care from another healthcare provider for BRLP
* Severe unmanaged comorbid conditions (e.g. substance abuse, major depressive disorder, stage 3 hypertension).
Characteristics of Intensity and Dependence to Physical Activity in Anorexia Nervosa

Etude d'épidémiologie clinique multicentrique (IMM), naturalistique, comparant un échantillon clinique à un échantillon de témoins issus de la population générale.

Cette recherche se fixe pour objectif principal de déterminer, sur un large échantillon de patients pris en charge pour anorexie mentale dans des unités de soins spécialisées, les caractéristiques de l'activité physique et la dépendance à l'exercice physique en comparaison avec des sujets issus de la population générale appariés pour l'âge et le sexe.

Nous faisons l'hypothèse que les patients anorexiques mentaux sont plus actifs et plus dépendants à l'exercice physique que des sujets de la population générale de même âge et de même sexe.


Eligibility Criteria:
Inclusion Criteria:

* Sujets de sexe masculin et féminin, âgés entre 13 et 23 ans.
* Donnant leur consentement éclairé (et celui des parents pour les mineurs)
* Pour l'échantillon clinique : prise en charge pour Anorexie Mentale (selon les critères DSM-IV) dans le département de psychiatrie de l'enfant et de l'adolescent de l'Institut Mutualiste Montsouris.
* Pour l'échantillon témoin : Sujets issus de la population générale (collégiens lycéens étudiants).

Exclusion Criteria:

* Personnes refusant la recherche
* Personnes souffrant d'une condition médicale majeure ou d'une invalidité.
The Effects of Facial Cooling on Fencing Performance

Fencing competitions can last between nine and eleven hours, during which athletes wear layers of protective equipment that impair evaporative heat transfer and spend a large amount of time at exercise intensities \> 85% maximum heart rate. Fencing performance can potentially contribute to heat stress due to increases in core temperature. Elevated core temperatures could hamper performance, and therefore the implementation of a strategy to reduce core temperature increases could lead to augmented fencing performance. Cooling methods are limited for use between fencing matches and during short breaks within a direct elimination match. Furthermore, due to multiple layers of thick protective equipment cooling method applications are limited primarily to the facial area. A potential cooling strategy, during fencing competition, includes the utilization of a water facial mist spray combined with fanning of the face. Therefore, the aim of this study is to investigate the novel use of facial cooling on core temperature, relevant physiological parameters, perceived exertion and thermal comfort and sensation during a simulated fencing competition performance, in male epee fencers.


Eligibility Criteria:
Inclusion Criteria:

* Trained fencers

Exclusion Criteria:

* Injured or a contraindicative medical condition