cyrilzakka/clinical-trials huggingface dataset:
Urdu Version of Fonseca Anamnestic Index: Reliability and Validity Study

The aim of study is to translate and culturally adapt Fonseca Anamnestic Index into Urdu language and to investigate the reliability and validity in Pakistani population over the age 18 years.

The English version of the Fonseca Anamnestic Index will be translated and culturally adapted as per previous recommendation. In Pakistani general population, Urdu Version of Fonseca Anamnestic Index will distributed among 140 participants choose by random sampling technique based on pre-defined inclusion and exclusion criteria. To test inter and intra-observer reliability of the final Urdu Version of Fonseca Anamnestic Index questionnaire will be filled on the same day, by two observers, and for the Inter-Observers assessment, with an interval of 30 minute between the first and the second application. Third assessment will carried out after 7 days by Observer-1, for intra-observer assessment. Data will be entered and analyzed using Statistical Package of Social Sciences Version 24. Internal consistency will be analyzed with Cronbach alpha value. Test- re-test reliability will be assessed using an intra-class correlation coefficient. The Urdu Version of Fonseca Anamnestic Index will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Patient with the age of 18 years.
* Having any previous history of temporo-mandibular joint pain
* Having any current condition of temporo-mandibular disorders.
* Both Genders are included equally.

Exclusion Criteria:

* Inability to understand or follow the instructions of the Fonseca Anamnestic Index.
* Suffering from any neurological condition.
* Suffering from any unstable medical condition.
* Patients with rheumatoid arthritis were also excluded
Rocuronium Effective Dose for Laparoscopic Cholecystectomy

This is an adaptative study where each participant's rocuronium dose will depend on the previous patient's response, being higher if it was not enough and lower if it was more than enough.

Rocuronium is one of the most used neuromuscular blockers to help intubation and to relax abdominal wall for laparoscopic surgery.

Rocuronium intubation dose can be enough for intubation but not last enough for excellent laparoscopic conditions. There is little variation in time from anesthesia induction to the end of the laparoscopy for cholecystectomy and avoiding excess rocuronium dose can help providing excellent conditions and fast track extubation.

Dixon's up-and-down method will guide this dose-finding study for the ED50.

Eligibility Criteria:
Inclusion Criteria:

* general anesthesia

Exclusion Criteria:

* deny participation
Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion

To investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in in Women Delivered Only by Cesarean Delivery.

Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device is attempted through a narrow cervical canal. intrauterine device insertion- related complications and side effects are more common among women who had never delivered vaginally.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant women
* Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
* Women who delivered only by cesarean section

Exclusion Criteria:

* Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.
* Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
* Allergy to isonicotinic acid hydrazide .
* Women refuse to participate in the study
Use of Computer-based Patient-reported Data to Assess Long Term and Late Effects of Head and Neck Cancer at the Point-of-care

Patient-reported information on outcomes such as symptom-burden and health-related quality of life (QoL) is regarded as a useful tool to improve quality of care in clinical cancer research. However, integrating patient-reported information in the routine clinical practice is often difficult due to excessive time use and practical barriers. Electronic data acquisitions, where the treating physician has immediately access to the patient-reported data in the subsequent consultation, have been shown to be beneficial in the everyday clinical decision making.

The aim of this study is to develop and test a computer-based patient-reported assessment tool that will assist the clinicians in tracking long term and late effects in head and neck cancer patients and investigate if the tool leads to improved symptom assessment of a range of head and neck cancer specific symptoms, which again may lead to improved symptom control and enhanced quality of life in the patients.

Patients with a diagnosis of head and neck cancer attending the oncology outpatient clinics at Herlev Hospital and physicians and nurses who work at the clinic will be invited to participate. The assessment tool will be developed with inspiration from prior international studies of symptom assessment in head and neck cancer patients and tailored so that it will fit into a Danish context. The tool will be tested in a controlled intervention study. In the intervention group, patients will complete the assessment tool in the patients waiting area prior to every scheduled consultation. The result will then be printed and provided to the treating physician. In the control group, the patients will complete the assessment tool prior to consultations. However, the data will not be provided to the physicians at any time.

To assess the impact of the tool on number of symptoms addressed during consultations and patients' overall quality of life, medical records will be reviewed for before start of intervention and again at 6 and 12 months follow-up. The patients will also complete the EORTC QLQ-C30 and the EORTC QLQ-H\&N35 at baseline and at 6 and 12 months follow-up. Furthermore, we will conduct a qualitative evaluation (semi structured interview and participant observations) of attitudes among clinicians and patients regarding the use of tool at the point of care.


Eligibility Criteria:
Inclusion Criteria:

* Prevalent recurrence free patients with cancers in the tongue, oral cavity, pharynx and larynx attending the oncology clinic at Herlev Hospital, Herlev, Denmark. 9 months to 5 years after end of treatment

Exclusion Criteria:

* Patients with recurrence of their cancers and patients still in treatment.
The Effect of Contrast Agents on the Anticoagulant Properties of Oral Factor Xa Inhibitors

The aim of this study is to evaluate the effect of iohexol as a contrast agent on the anticoagulant activity of oral factor Xa inhibitors.

The study included 65 people who underwent contrast computerized tomography (CT). The study patients were divided into 4 groups. Patients in group 1 were using rivaroxaban (20 patients), patients in group 2 were using apixaban (20 patients), patients in group 3 were using edoxaban (20 patients), and group 4 was the control group (5 volunteers). Iohexol (60 ml) was used as a contrast agent. Two tubes were used to collect 2 ml of blood from the patients at 4 hours after the drug dose (rivaroxaban, apixaban, or edoxaban) and 1 hour after the contrast CT (CT was performed 3 hours after the drug was taken). In the control group, at any time and 1 hour after contrast CT, 2 tubes of 2 ml of blood were collected. The anticoagulant properties of rivaroxaban, apixaban, and edoxaban were evaluated using anti-factor Xa levels.

Eligibility Criteria:
Inclusion Criteria:

1. the use of oral factor Xa inhibitors (patients with nonvalvular AF and CHA2DS2-VASc Score ≥2),
2. age of 21-80 years,
3. no contraindications for anticoagulation use,
4. GFR greater than 30,
5. volunteering to participate in the study, and
6. patients who needed to use contrast agent (iohexol) for CT examination. -

Exclusion Criteria:

1. coagulopathy,
2. severe hepatic insufficiency,
3. chronic systemic or inflammatory diseases,
4. patients lighter than 60 kg,
5. malignancy,
6. creatinine value above 1.5 mg/dl, and
7. not providing consent to participate in the study -
Fear Conditioning Paradigm in Obesity

Fear processing in obesity and specifically the ability to i) learn and remember threatening stimuli, and ii) implicitly (i.e., unconsciously) and explicitly (consciously) discriminate them from neutral ones, will be investigated in affected individuals through the fear-conditioning paradigm.


Eligibility Criteria:
Inclusion criteria:

* Right-handed
* diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30).

Exclusion criteria:

• concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.
Patient and Physician Attitudes About Informed Consent for Emergency Department (ED) Computerized Axial Tomography (CT) Scans

Hypothesis: The majority of Emergency physicians and patients do not feel that specific informed consent should be obtained for ED CT scans.

Secondary Hypothesis: Emergency attending physicians and residents will have similar attitudes about CT scan consent issues. Physician attitudes toward obtaining consent for CT scans will change after an educational program about the associated risks.

ED residents and ED attendings who attend grand rounds will be given a survey and asked to anonymously complete the first portion before grand rounds (Figure 1, example A). The first portion will assess basic demographics, CT ordering patterns and experiences, and attitudes about informed consent. They will be provided with an educational program at grand rounds that reviews current literature relevant to CT utilization and consent issues. After the lecture they will be asked to complete the second section of the survey (Figure 1, Example B). Both portions of the survey will be simultaneously returned in a sealed envelope and placed in a collection box at grand rounds.

ED attendings who do not attend grand rounds will only be asked to complete the first portion of the survey (Figure 1, example A). Resident or attending consent to participate will not be coerced, and participation will be implied by completion of the survey.

Eligibility Criteria:
Inclusion Criteria:

* Current ED resident and attending physicians
* An ED patient (or their surrogate) that is able to understand and respond in writing to the questions given.

Exclusion Criteria:

* Anyone who declines to participate.
* An ED patient who is not able to understand questions or respond in writing to the questions given (and does not have a surrogate that understands questions and respond in writing to the questions given).
Motor Imagery in High-Risk Pregnants

The aim of this study is to determine the acute effects of motor imagery exercises on fetal heart rate, uterine contractions, maternal heart rate, blood pressure, oxygen saturation and well-being in high-risk pregnant women.

Bed rest is often recommended in high-risk pregnant women to prevent complications from reaching dangerous levels.

Pregnant women recommended bed rest can benefit from exercise in order to overcome this process more easily, to reduce the negative consequences of inactivity and to prevent possible risks.

However, there may be differences between the view of high-risk pregnant women and the view of healthy pregnant women. Motor imagery refers to a mental process in which an individual mentally imagines that movement without actually eliciting an active movement. Studies have shown that similar brain regions are activated during movement performance and movement imagery. It has been reported in the literature that progressive relaxation exercises performed under mental/motor imagery guidance in healthy pregnant women and pregnant women lead to an improvement in maternal anxiety, stress and fetal attachment scales and a decrease in maternal systolic/diastolic blood pressure. However, as far as the investigators know, there is no study that applies the exercise protocol that can be given to healthy pregnant women to high-risk pregnant women with motor imagery and examines acute responses on fetal and maternal parameters.

Eligibility Criteria:
Inclusion Criteria:

Risky pregnant women who have completed the 12th week of pregnancy, received inpatient treatment and have any of the following risk factors will be included in the study:

* Pregnant women who are at risk for obstetric outcomes such as cervical insufficiency, multiple pregnancy and uncontrolled gestational diabetes, and physical activity restriction is recommended due to these conditions, and exercise is contraindicated,
* Pregnant women with a maternal body mass index above 30, which causes them to be physically inactive

Exclusion Criteria:

* Pregnant women who are at risk for obstetric outcomes such as gestational diabetes mellitus and pregnancy-induced hypertension, but physical activity is recommended
* Pregnant women with severe cardiovascular, pulmonary and systemic disorders
* Pregnant women with psychological seizure disorders
* Pregnant women who do not have any mental problems that prevent cooperation and understanding
* Pregnant women with any medical condition that prevents the safe and effective implementation of interventions.
* Pregnant women in other high-risk groups (such as early membrane rupture, placenta previa, preeclampsia) that may have early intervention in terms of obstetric outcomes.
Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

The purpose of this clinical research study is to determine the safety, pharmacokinetics, immunogenicity in humans, the recovery time required from the biologic effects and the optimal biologic dose range of BMS188667 (CTLA4Ig)


Eligibility Criteria:
Inclusion Criteria:

* Men or women who received adequate counseling and were judged reliabel in their use of contraceptive measures.
* Diagnosis and documentation of stable psoriasis vulgaris of at least 6 months duration.
* Psoriasis vulgaris total body surface area involvement between 10% and 49% (Overall Disease Severity Score \[ODSS\]of 4-7 inclusive).
* Failure of toxicity or inefficacy of at least one standard antipsoriatic therapy including topical treatment, etretinate, phototherapy, or methotrexate.

Exclusion Criteria:

* Treatment with: a) Retinoids within 2 years, b) cyclosporin A, systemic corticosteroids, methotrexate, or an investigational agent within 16 weeks, c) any phototherapy or photochemotherapy within 4 weeks d) any topical psoriasis treatment other than emollients within 2 weeks prior to enrollment.
* No clinical response to a prior adequate therapeutic trial of cyclosporin A
* Prolonged exposure to the sun within 4 weeks prior to the first dose.
* Guttate, erythrodermic, or pustular psoriasis.
* Spontaneously improving or rapidly deteriorating psoriasis vulgaris.
Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life

Patients in a known palliative setting and with localized symptoms due to tumor growth will be evaluated for their quality of life before and after a surgical intervention (primary endpoint). Medical outcome in terms of length of stay in hospital, length of stay on a intensive care unit, complications, reinterventions will be recorded (secondary endpoints). The investigators will also observe patients with conservative treatment.

What is the impact on quality of life by operations in symptomatic advanced tumor disease ? After informed consent patients in known palliative situations and with localized symptoms due to tumor growth will be enrolled in our study. The investigators will assess Quality of life with the EORTC QLQ C30-questionnaire and collect data about the disease an the actual state of the patients.

By the time of discharge out of hospital the investigators will hand out the questionnaire again and the investigators will collect data regarding the therapies, operations, complications, reinterventions, time spent on a intensive care unit, time spent in hospital.

The questionnaire will be completed after 4 and 12 weeks as well.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* tumor patients within a known palliative situation, patients do know about the absence of a curative treatment
* patients are symptomatic because of localized tumor growth
* patients having an operation for symptom relief or treated without surgery

Exclusion Criteria:

* patients with an only intraoperatively seen palliative tumor disease
* debulking operations, prophylactic operations for prevention of symptoms, operations for venous access (an exception will be made for enteric bypass operations in patients with a yet preserved passage)
* dementia, age ≤ 18, barrier of speech
Autologous Fecal Microbiota Transplantation for Patients With Acute Graft-versus-Host Disease

This study aims to assess the safety and efficacy of autologous fecal microbiota transplantation (FMT) in gastrointestinal (GI) related graft-versus-host disease (GVHD). Stool for FMT will be prepared from pre-allogeneic stem cell transplantation (Allo-SCT) period. This strategy might offer a novel and safe therapeutic approach for these patients, who suffer from high disease related morbidity and mortality and are refractory to multiple treatments.

All candidates for Allo-SCT at BMT unit in RHCC will be screened for study inclusion and exclusion criteria. Seven to fourteen days prior to Allo-SCT (before initiation of SCT related antimicrobials), all consenting patients will supply stool sample (first stool sample), which will serve as the autologous FMT sample, and clinical data will be collected. Patients who will develop GI related GVHD will be asked to supply another stool sample 7±2 days after the appearance of GVHD related symptoms (second stool sample). Clinical and laboratory data will be collected. Another stool sample will be collected 7-14 following autologous FMT (third stool sample), and clinical data and outcome will be documented. Day 1 of the study will be defined as day of Allo-SCT, and follow up period is 6 months. Complementary data will be collected from the electronic medical records.

Eligibility Criteria:
Inclusion Criteria:

\* Allo-SCT patients above 18 years of age with acute steroid-resistant GI-related GVHD grade III-IV.

Exclusion Criteria:

* Prior inclusion to an interventional study
* Pregnant or lactating women
* Previous Allo-SCT
* Known multi-drug resistance carriage prior to stool collection
* Severe colitis of any etiology or a history of inflammatory bowel disease (IBD)
* Uncontrolled infection (hemodynamic instability, ongoing fever or bacteremia within 3 days after antibiotics administration)
* Active GI bleeding
* Absolute neutrophil count \< 500 cells/microL
* Patients who cannot give informed consent
Pigment Dispersion Syndrome: Natural History and Possible Protective Effect of a YAG Laser Iridotomy

STUDY AIMS

1. To determine the 10-year conversion rate from pigment dispersion syndrome (PDS) to pigmentary glaucoma (PG)
2. To evaluate the possible protective effect of a Yag-laser iridotomy

1154 workers in the Parma area will be screened for eligibility to long-term use of video-monitors. Those referred to the Glaucoma Clinic for suspected PDS will be enrolled in the study.

In a prospective study on the natural history of PDS and PG, Richter et al. (Arch Ophtal 104:211-5, 1986) found an association between "active pigment dispersion" and elevated IOP. Therefore, in order to evaluate the "stability" of the pigment, a phenylephrine test will be performed following the method reported by Epstein et al (1978) AJO 85:43-50. The test will be performed by one investigator (SAG)and was considered positive if \> "grade 1+" (i.e. at least 10 particles in a single light beam). Eyes showing a positive test will be considered as "high-risk" for conversion to PG.

Yag laser iridotomy will be performed in patients showing both eyes at high risk. One eye only (randomly chosen) will be treated. the fellow eye will be left untreated and considered as internal control.

Low risk eyes will be followed without any intervention.

Eligibility Criteria:
Inclusion Criteria:

* Krukenberg spindle
* Slit-like mid peripheral iris defect
* Pigment in \> 270° of AC angle

Exclusion Criteria:

* IOP \> 18 mmHg
* PEX (full mydriasis)
* w/w field defect (Octopus G1 program)
Mobile-Phone-Based Psychoeducation for Dementia Caregivers in Vietnam

The goal of this study is to determine whether a mobile phone-based psychoeducational intervention can reduce stress among caregivers of individuals with dementia in Vietnam. The primary research question is: Does the intervention reduce levels of depression, anxiety, and stress among participants? The secondary research question is: Does the intervention increase caregivers' knowledge about dementia, enhance social support, or reduce caregiver burden?

The study consists of two groups: an intervention group and a control group. Participants in the intervention group will receive psychoeducational content through the Zalo app on their mobile phones. Weekly, they will be provided with a topic related to dementia care, such as daily caregiving, fall prevention, pressure injury prevention and care, self-care, and coping as a caregiver. Levels of depression, anxiety, and stress will be assessed both before and after the intervention. In the control group, participants will continue receiving standard care.

Eligibility Criteria:
Inclusion Criteria:

* Primary Caregiver Requirement: Participants must have been the primary caregivers of poeple with dementia for at least the past 6 months and plan to continue in this role for the next 6 months of the intervention. Patients with demeentia criteria: Patients must have been diagnosed with dementia for at least 6 months and reside within the community.
* Language and Education Requirement: Participants must be able to read and understand Vietnamese (with at least a primary education level) and be willing to participate in the study.
* Smartphone Requirement: Participants must own a smartphone with the Zalo app or be willing to install it (with a brief training session provided for new users).
* Age Requirement: Participants must be aged 18 years or older.

Exclusion Criteria:

* Having any acute diseases or cognitive impairment (screening by Mini-Cog) or
* Having vision or hearing impairment
Investigation of Human Laryngeal Evoked Brainstem Potentials

The primary purpose of this study will be to determine whether the proposed study protocol will allow for reliable detection of the human Laryngeal evoked brainstem responses (LEBR). Laryngeal evoked brain stem responses will be recorded from five test subjects under general anesthesia in the operating room with the assistance of an electrophysiologist with expertise in evoked potentials. Once the feasibility of obtaining tracings are established on the first few subjects, responses will be recorded from other test subjects with the aim of determining the optimal placement of stimulating electrodes and detection leads necessary to elicit an adequate response. The effect of varying the stimulus intensity will also be studied. Once parameters for testing have been standardized, normative configurations for the laryngeal evoked brainstem response tracings can be determined by patients both in the office setting and in the operating room.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects undergoing thyroid or other open neck surgeries

Exclusion Criteria:

* Current or recent (within one month) tracheostomy
* Vocal cord paralysis
* History of Stroke
* History of Diabetes Mellitus
* History of Neurologic Disease
* History of Radiation to the Neck
* History of Brain Surgery
* History of Neck Surgery
* Recent Laryngeal Surgery (within one month)
* Recent Intubation (within two weeks)
* Laryngopharyngeal Reflux Disease
* Allergy to Lidocaine
* Allergy to Oxymetazoline