cyrilzakka/clinical-trials huggingface dataset:
The Effect of STarT Back Screening Tool

The aim of this study is to examine the effectiveness of StArt Back Tool test in determining prognosis and loss of workforce in patients presenting with low back pain complaints in the acute-subacute period and to examine the relationship between StArt Back Tool test and kinesophobia.

Low back pain (LBP) is a common disorder that affects about 80% of adults at least once in a period of their life. 10% of low back pain becomes chronic and can affect the quality of life negatively and lead to disability. The STarT-Back-Tool was developed to identify people with poor prognosis, such as difficulty returning to work, loss of work force, disability. It has been reported that it would be beneficial to categorize patients according to their risk levels with this tool and plan treatment in primary care treatment centers. Being able to identify patients with a high probability of becoming chronic in the early period is very important to reduce or prevent disability that may occur. The aim of this study is to examine the effectiveness of StArt Back Tool test in determining prognosis and loss of workforce in patients presenting with low back pain complaints in the acute-subacute period and to examine the relationship between StArt Back Tool test and kinesophobia.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* Low back pain for less than 3 months
* Sign the written informed consent.
* Being able to read and write

Exclusion Criteria:

* Inflammatory rheumatologic disease
* Having a history of lumbar surgery
* Back pain for more than 3 months
Functional Epiphora Management Via Different Dacryocystorhinostomy (DCR) Techniques

135 eyes of 135 patients treated between 2005 and 2017 will be included in this study. The diagnosis of functional epiphora was made based on a patent lacrimal system with a delay in the fluorescein dye disappearance test (FDDT) or dacryoscintigraphy (DSG) without any ocular surface or eyelid abnormalities. The absence of epiphora and normalization of FDDT postoperatively was defined as success. The study's hypothesis is that external DCR with a suitable technique will have better results compared to endonasal and transcanalicular DCR


Eligibility Criteria:
Inclusion Criteria:

* patent lacrimal irrigation and delay in the lacrimal transit time demonstrated by fluorescein dye disappearance test (FDDT) or a dacryoscintigraphy (DSG)

Exclusion Criteria:

* Dry eye (tear break up time less than 10 seconds), ocular surface disorders, eyelid malposition or laxity, orbicularis weakness, partial block or stenosis of the lacrimal drainage, history of previous nasal, lacrimal, or ophthalmic surgeries, and a postoperative follow-up time less than six months
Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites

This phase IIIb, randomized, comparative, multi-center study is designed to evaluate two AQUACEL Ag protocols of care for the management of split-thickness donor sites. Both protocols of care will utilize AQUACEL Ag as the primary dressing. As per the randomization assignment, one protocol of care will have the AQUACEL Ag initially covered with a gauze dressing to create an adherent state and in the other protocol of care the AQUACEL Ag will be covered with a transparent film to maintain a gelled state.

The primary objective of the study will be to quantify the proportion of subjects healed at 14 days. Secondary objectives will include: time to healing, degree of pain at dressing change and while wearing the dressing, simplicity of use, resources used in treatment and safety. Approximately 68 subjects will be enrolled from 10 centers from within the US and Canada.


Eligibility Criteria:
Inclusion Criteria:

* Subject or legally authorized representative must provide written informed consent.
* Subject who is younger than legal consenting age must have a legally authorized representative who will provide written informed consent.
* The subject is scheduled to undergo a split-thickness skin graft (autograft)
* Harvesting of the donor site must be limited to the location and size of the anterior thigh
* The selected anterior thigh must be a first - time harvesting.

Exclusion Criteria:

* Subjects with known skin sensitivity to any of the dressing components.
* Subjects who require a full thickness graft.
* The subject with a poor prognosis, which would make it unlikely that he/she would survive the 21 day study period.
* Subjects who have been previously randomized into the study, or who are presently participating in another clinical trial.
Onsite Tobacco Cessation Treatment for Patients With PAD

Tobacco cessation treatment is needed for individuals with peripheral artery disease (PAD) to improve symptoms, lower cardiovascular risk, and prevent amputation. While such treatment is effective, many PAD patients do not receive cessation therapy. Participants will receive nicotine replacement therapy, counseling, and and complete questionnaires. We hypothesize that integrating tobacco cessation services into a dedicated PAD clinic (OU CVI Limb Preservation Clinic) can improve tobacco cessation rates and improve PAD-related health outcomes in this at risk population.


Eligibility Criteria:
Inclusion Criteria:

* Have diagnosed peripheral artery disease
* Tobacco user
* 18 years of age or older
* Willing/able to attend all study visits
* Be able to read, speak, and understand English

Exclusion Criteria:

* Do not meet the specified inclusion criteria above
BOOM-IBD2 Pivotal Clinical Trial

The BOOM-IBD2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of IBD.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 to 85 years of age
* Diagnosed with ulcerative colitis
* Ability and willingness to consent to participate by signing the informed consent form
* Ability to comply with the protocol and willingness to comply with all follow up requirements

Exclusion Criteria:

* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study
* Any psychiatric or personality disorder at the discretion of the study investigator
* Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)
* Active clostridium difficile infection of the colon
* Active cytomegalovirus (CMV) infection of the colon
* Evidence of colonic perforation
* Fulminant colitis requiring emergency surgery
* Microscopic, ischemic or infectious colitis
* Unresected neoplasia of the colon
* Colonic stricture unable to pass a colonoscope
* Current evidence of cancer in the gastrointestinal tract
* Current participation in another clinical trial
* Previous history of surgery for ulcerative colitis, or probably to require such intervention
* Previously implanted with a neurostimulation device or participated in a neurostimulation trial
* Inability to operate the patient programmer
Covid-19 Pandemic and Use of Video Laryngoscopy

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a highly contagious infection with the highest viral load in the upper respiratory secretions. Despite using personal protective equipment, SARS-CoV-2 contamination to the healthcare personnel is possible during the airway management of infected patients. Direct laryngoscopy remains as the most common method for endotracheal intubation. Our study aimed to compare the use of video laryngoscopy with direct laryngoscopy for tracheal intubation in adult patients receiving general anesthesia for elective surgery during the COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Elective surgery

Exclusion Criteria:

* Intraoral or neck surgery
* gastroesophageal reflux
* delayed gastric emptying
* pregnancy
* scoliosis
Effectiveness of the Iconic Therapy for Borderline Personality Disorder Symptoms

Borderline personality disorder (BPD) is the most prevalent personality disorder in young community population whose most severe complication is suicide. Pharmacotherapy should not be used as the primary treatment for BPD as the benefits are unclear. Psychotherapy is the main treatment for people with BPD and the current recommendation is adapting available comprehensive treatments to develop easier and briefer therapies that are also effective. Iconic Therapy is an innovative option whose good clinical results should be validated on a clinical trial.

Borderline Personality Disorder (BPD) in the early adulthood is an increasing diagnosis among general population. First symptoms detection and early intervention might help prevent its aggravation and further BPD diagnosis. Iconic Therapy is an innovative manual-driven psychotherapy to specifically and intensively treat BPD symptoms. Preliminary clinical results are good. The aim of the present study is to assess the effectiveness of the Iconic Therapy in comparison to a support structured therapy in an ecological setting (Spanish public specialized mental health care). The study is planned as a randomized controlled prospective trial that will randomize 60 young people (15 to 25 years old) with suicidal ideation/self-injuring behaviour and borderline personality traits. Participants will be randomly assigned to one of the two groups: Iconic Therapy or support structured therapy on a 1:1 basis. Both the Iconic Therapy and the support therapy programs consist of 10-12 weekly sessions delivered by two trained psychologists for about 8-12 outpatients on group format. The primary outcome measure is the change of symptoms severity assessed by the Borderline Personality Disorder List (BSL-23). Secondary outcomes include suicidal ideation and behavior, non-suicidal self-injures maladjustment to the daily life and economic evaluation for health care. Assessments will be performed at baseline after the intervention 6 and 12 months of follow-up. It is hypothesized that those attending the Iconic Therapy group will show a permanently reduction of the severity of symptoms as compared with those attending the structured support group. Data will be analyzed using generalized estimating equations (GEE) models.

Eligibility Criteria:
Inclusion Criteria:

* Aged 15-25 years old
* Suicidal ideation and/or self-injuring behavior
* BPD behavioural trends defined as the cut point for alarming BPD traits (\>38 score) on Exploratory Questionnaire of Personality-III-BPD (CEPER-III-BPD)
* Sufficiently proficient in Spanish to follow the treatment

Exclusion Criteria:

* Antisocial personality disorder as measured in the Clinical Interview for Diagnostic and Statistical Manual (DSM-IV Axis II) (SCID-II)
* Substance or alcohol abuse
* High suicidal risk
* Negative expectations to be enrolled in the study as measured \< 35 by the Expectation of Treatment Scale (ETS)
An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families.

The FOP burden of illness (BoI) survey aims to assess the impact of the burden of FOP on patients and their families. The study is being conducted online and available for residents in Argentina, Brazil, Canada, France, Germany, Italy, Japan, Mexico, Poland, Russia, South Korea, Spain, Sweden, the US, and the UK.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals meeting one of the two categories below (A or B) are eligible to participate: A. Any individual with FOP, of any age; B. Any individual who is a family member of a person with FOP (i.e. either a parent / legal guardian or a sibling) and who is aged 18 years and older
2. All adult participants and parents / legal guardians of minors should provide informed consent before starting filling out the survey

Exclusion Criteria:

1. Any individuals who are unable to complete the online survey independently or to get assistance to physically enter the answers
Curcumin Biomarkers

Colorectal cancer is a major problem in the United States and other developed countries. A safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia. Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of years as a traditional remedy. Curcumin blocks a number of targets involved in tumor initiation, promotion, and progression, and is considered a promising chemopreventive agent. The investigators propose to enroll 40 patients after screening colonoscopy who will have rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators will use microarray analysis to identify genes that are modified by curcumin that could be used as biomarkers in future chemoprevention studies. The study will also evaluate tolerability and toxicity.


Eligibility Criteria:
Inclusion Criteria:

1. Age 40 - 80.
2. A willingness to follow the study protocol, as indicated by provision of informed consent to participate
3. Good general health

Exclusion Criteria:

1. Familial colorectal cancer syndromes (e.g. Hereditary Non-Polyposis Colon Cancer, Familial Adenomatous Polyposis)
2. Ulcerative colitis or Crohn's disease.
3. History of large bowel resection for any reason
4. Diagnosed narcotic or alcohol dependence
5. Unwillingness to forgo curcumin/turmeric-containing supplements during the trial or consumption of curry/turmeric at meals \> 3 times a week.
6. Allergy to turmeric/curcumin.
7. Women with childbearing potential who do not agree to practice effective birth control.
8. Individuals with creatinine, AST or ALT above 1.5 times the upper limit of normal at baseline.
9. Personal or inherited bleeding disorders or therapeutic anti-coagulation with warfarin.
10. Women who are pregnant or nursing.
11. Individuals who have taken antibiotics within the three months prior to enrollment.
Humidification Needs

A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP. This study will also measure how much humidification is required to treat subsequent upper airway discomfort/dryness from mouth leak by utilizing different levels and types of humidification.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over

Exclusion Criteria:

* Inability to give consent
* Currently pregnant or think they may be pregnant
* Current nasal symptoms or chronic nasal disease
* Contraindicated for PAP therapy
Impact of a Predetermined Day 5 ET vs. a Predetermined Day 6 ET on Clinical Pregnancy Rate After ICSI Treatment

The aim of this prospective multicenter study is to investigate the influence of a predetermined embryo transfer on day 6 compared to a predetermined embryo transfer on day 5. The study population consists of the control group (predetermined embryo transfer on day 5) and the study group (predetermined embryo transfer on day 6). The primary endpoint is the clinical pregnancy rate (detection of a gestational sac) per embryo transfer and the secondary endpoint is the abortion rate per clinical pregnancy. The data from the multicenter study are obtained at three test centers (Fertility Center Dortmund, Fertility Center Essen and Fertility Center Bad Münder).

Since a predetermined embryo transfer on day 5 cannot be performed in some centers on every day of the week (e.g. sunday), some IVF centers perform a predetermined embryo transfer on day 4 or day 6, respepectively. Data for a predetermined embryo transfer on day 4 versus a predetermined embryo transfer on day 5 showed no significant differences regarding clinical pregnancy rates. However, since a day 6 transfer might offer advantages in assessing the development stage, the prolonged culture and transfer on day 6 transfer might be a very promising option.

As of yet, there are no prospective studies in the current literature examining the equivalence of a predetermined embryo transfer on day 6 versus a predetermined embryo transfer on day 5.

The aim of this prospective multicenter study is to investigate the influence of a predetermined embryo transfer on day 6 compared to a predetermined embryo transfer on day 5. The study population consists of the control group (predetermined embryo transfer on day 5) and the study group (predetermined embryo transfer on day 6). The primary endpoint is the clinical pregnancy rate (detection of a gestational sac) per embryo transfer and the secondary endpoint is the abortion rate per clinical pregnancy. The data from the multicenter study are obtained at three test centers (Fertility Center Dortmund, Fertility Center Essen and Fertility Center Bad Münder).

Eligibility Criteria:
Inclusion criteria:

The patients to be included should be ≥18 years old. There is no upper age limit. Only ICSI treatments with a single embryo transfer (SET) should be included. Only the first cycle per patient should be evaluated.

Exclusion criteria:

none
A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma

This is a first-in-human Phase I, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089 and make a preliminary assessment of anti-tumor activity in patients with R/R MM for whom no established therapy for MM is appropriate and available or who are intolerant to those established therapies.


Eligibility Criteria:
Inclusion Criteria

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of at least 12 weeks
* R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
* Measurable disease

Exclusion criteria:

* Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for the treatment of cancer within 4 weeks before first RO7297089 infusion
* Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first RO7297089 infusion
* Prior treatment with CAR-T therapy within 90 days before first study drug administration
* Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first RO7297089 infusion
* Autologous stem cell transplantation within 100 days prior to first RO7297089 infusion
* Allogeneic stem cell transplantation within 180 days prior to first RO7297089 infusion or requiring immunosuppression for treatment or prophylaxis of graft versus host disease
* Primary or secondary plasma cell leukemia
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring treatment with IV anti-microbial therapy within 14 days prior to first RO7297089 infusion
* Significant cardiovascular disease
* Current CNS involvement by MM
Prediction Value of Ecg on Coronary Slow-flow

The investigators aimed to investigate the vessel heterogeneity of Thrombolysis in Myocardial Infarction frame count (TFC) in the three coronary arteries, and its relation to P-wave dispersion, in patients with coronary slow flow and otherwise normal coronary arteries.

Coronary slow flow (CSF) phenomenon, which is characterized by delayed coronary opacification in the absence of obstructive epicardial coronary artery disease, is a relatively common finding in patients undergoing routine coronary angiography and is often associated with chest pain. In some patients with CSF, blood flow may be heterogeneously distributed in the three coronary arteries, suggesting the heterogeneously distributed microvascular dysfunction in the myocardium. However, the vessel heterogeneity of Thrombolysis in Myocardial Infarction (TIMI) frame count (TFC) has not been fully elucidated.

P-wave dispersion (PWD) is defined as the difference between the longest and the shortest P-wave duration recorded from multiple different surface electrocardiogram (ECG) leads, and it has been reported to be associated with inhomogeneous and discontinuous propagation of sinus impulses5, which are well known electrophysiologic characteristics of the atrium prone to fibrillation. Although it is plausible to hypothesize that PWD might be associated with the heterogeneously distributed microvascular dysfunction, and previous studies have demonstrated the abnormal PWD in patients with CSF, the correlation between TFC heterogeneity and PWD has never been evaluated.

In this study, the investigators aimed to investigate the vessel heterogeneity of TFC in the three coronary arteries, and its relation to PWD, in patients with CSF and otherwise normal coronary arteries.

Eligibility Criteria:
Inclusion Criteria:

* All of the subjects had chest pain and were referred to our catheterization laboratory for coronary angiography

Exclusion Criteria:

* Valvular or congenital heart disease
* Atrial fibrillation or other arrhythmia that would interfere with ECG analysis
* Left ventricular hypertrophy
* Myocardial or pericardial disease
* Chronic obstructive pulmonary disease, or electrolyte abnormalities.
* Subjects taking antiarrhythmic, antiischemic, β-blocker, or calcium-channel blocker medications were also excluded from the study.
Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.

A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults

Eligibility Criteria:
Inclusion Criteria:

* 18 to 90 years of age inclusive
* Female patient is authorized to participate if at least one of the following criteria are met:

  1. Surgical sterilization
  2. Age ≥50 years and postmenopausal as defined by amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments
  3. Age \<50 years and postmenopausal as defined by documented LH and FSH levels in the postmenopausal range PLUS amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments
  4. Patient has a negative serum pregnancy test (serum ß-human chorionic gonadotropin \[ß-hCG\]) within 1 day prior to study entry, and agrees to use highly effective contraception methods during treatment and for at least 7 days after last dose of IV study therapy
* Intraoperative/postoperative enrollment with confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
* Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory response; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections

Exclusion Criteria:

* Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious
* Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation
* Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis
* Patient is considered unlikely to survive the 6 to 8 week study period or has a rapidly progressive or terminal illness, including septic shock that is associated with a high risk of mortality