cyrilzakka/clinical-trials huggingface dataset:
Standard Versus High Dose ED-Initiated Buprenorphine Induction

This study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder (OUD) to compare Standard Dose Induction (SDI) and High Dose Induction (HDI) on rates of participation in OUD treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.

This study will recruit, train, and provide resources to approximately 4 ED systems throughout the U.S. to recruit ED patients presenting with OUD not receiving medications for opioid use disorder (MOUD) as part of an RCT to compare SDI (Zubsolv 5.7/1.4 mg buprenorphine/naloxone\* plus 2 placebo tablets) with HDI (three Zubsolv 5.7/1.4 mg\* buprenorphine/naloxone tablets) to evaluate rate of participation in OUD treatment within 10 days post-randomization and differences in outcomes of tolerability, opioid withdrawal symptoms, craving, and use of illicit drugs.

Eligibility Criteria:
Inclusion Criteria:

All patients enrolled into the study must:

1. Be 18-65 years of age.
2. Be treated in the ED during study screening hours.
3. Meet DSM-5 diagnostic criteria for moderate to severe OUD.
4. Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment).
5. Have a urine toxicology test that is positive for opioids.
6. Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

All patients enrolled into the study must not:

1. Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit.
2. Have a known hypersensitivity reaction to buprenorphine/naloxone
3. Be actively suicidal or severely cognitively impaired precluding informed consent.
4. Require ongoing prescription for opioid analgesics.
5. Have a physical exam or reported history consistent with severe liver failure
6. Have a positive urine test for methadone and reported use in the past 72 hours
7. Be a prisoner or in police custody at the time of index ED visit.
8. Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments)
9. Have prior enrollment in the current study.
10. Receiving MOUD treatment within the past 7 days.
11. Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit
12. Have a respiratory rate \<8 or oxygen saturation \<93%
13. Be a participant in any other clinical trial in which medications are being delivered or the use of an investigational drug or device within the last 30 days
Neural Mechanisms of Muscle Control in Individuals With Knee Pain

This is a randomized controlled trial of knee muscle versus hip muscle strengthening for Patellofemoral Pain Syndrome.

Rationale: Two prior randomized controlled trials (RCT) have highlighted the importance of hip muscle activation and strengthening as a treatment strategy for patellofemoral pain (Khayambashi, 2014; Khayambashi, 2012). Here, we propose a pilot study to acquire preliminary data to power a larger study to reveal the neural mechanism underlying the effectiveness of this intervention to promote its evidence-based incorporation into clinical practice.

Intervention: 4 weeks of quadriceps muscle versus 4 weeks of hip strengthening exercises.

Purpose: To determine changes in brain functional connectivity related to pain reduction induced by the strengthening exercises.

Study population: Males and females with a history of unilateral knee pain.

Methodology: Functional magnetic resonance imaging (fMRI) will be used to quantify functional connectivity of brain regions related to hip muscle activation. Functional connectivity will be quantified before (pre) and after (post) 4 weeks of quadricep or hip muscle strengthening exercises.

Arms: As above, there are 2 arms. 4 weeks of quadriceps strengthening exercises (Arm 1) versus 4 weeks of hip strengthening exercises (Arm 2).

Outcomes: At the pre and post-intervention sessions in each participant, we will quantify the brain functional connectivity between hip muscle motor cortex and the 1) thalamus, 2) basal ganglia, and 3) insula, and 4) the periaqueductal gray. We will also quantify self-report of pain and biomechanical function of the knee and hip.

Follow-up: A six month follow-up is planned for this pilot study.

Analysis Plan and Statistics: Functional connectivity of hip muscle motor cortex will be extracted using standard statistical software for brain mapping. A repeated measures ANOVA will be used to assess change in functional connectivity in the hip and knee group. Pain decreases in the both groups will be quantified and reported.

Eligibility Criteria:
Inclusion Criteria:

1. Pain located specifically around the patellofemoral articulation (vague or localized).
2. Readily reproducible pain (3 out of 10 on a visual analog scale) with at least 2 of the following functional activities commonly associated with PFP: stair ascent or descent, squatting, kneeling, prolonged sitting, or isometric quadriceps contraction.
3. Reports of pain greater than 3 months duration.

Exclusion Criteria:

1. Previous history of knee surgery.
2. History of traumatic patellar dislocation.
3. Neurological involvement that would influence gait.
4. Contraindications to MR imaging: implanted electronic devices (i.e. pacemaker), or metallic implants (i.e. aneurysm clips, fixation screws).
Molecular Profiling of Colorectal Cancer

In this translational research study, Formalin-Fixed-Paraffin-Embedded (FFPE) tumor tissue blocks from patients with early-stage (II-III) colorectal cancer will be assessed for a comprehensive cancer gene panel from NIPD Genetics (https://www.nipd.com/) targeting regions in 37 clinically relevant cancer genes.

The colorectal cancer panel includes an extended list of clinically relevant genes, designed to target clinically actionable and clinically significant mutations that will provide physicians with genetic information regarding a) prediction of the patient's response to targeted therapy, b) prognosis, that is, prediction of clinical outcome, c) diagnosis and molecular classification of colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Surgically resected early-stage (II-III) colorectal cancer
* Availability of biological material

Exclusion Criteria:

* Metastatic disease (stage IV) at initial diagnosis
A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma

The purpose of the study is to evaluate in subjects suffering from nocturnal asthma, the efficacy and safety of modified release Prednisone on signs and symptoms.

Study with completed results acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* The subject must be able to understand the terms of the written informed consent form, and must provide a dated and signed form before the start of any study procedure
* At least 18 years old
* Patient having a diagnosis of asthma dating back more than 6 months at the time of inclusion
* Asthma necessitating a continuous treatment by oral corticoids
* A minimum of 3 nocturnal awakenings due to asthma during the last screening week
* Stable dose of oral glucocorticoids for at least 4 weeks prior to inclusion into the study
* No change in asthma medication during the last 4 weeks prior to V0
* Non-smoker or ex-smoker (having stopped smoking more than one year previously and with a smoking history of less than 10 pack years )
* Female patients of childbearing potential must be using a medically accepted contraceptive regimen
* Able to perform the required study procedures including handling of medication containers and diaries

Exclusion Criteria:

* Poorly controlled asthma, defined as meeting at least one of the following within the 4 weeks prior to Visit V0:

  * hospital admission for asthma (including treatment in an emergency room),
  * a lower airway infection,
* Diagnosis of chronic obstructive pulmonary disease or other relevant lung diseases (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, active tuberculosis, interstitial lung disease)
* Clinically significant abnormalities of the hematological or biochemical constants
* Pregnancy or breastfeeding
* Participation in another clinical study within 30 days preceding Visit V0,
* Re-entry of patients previously enrolled in this trial,
* Suspected inability or unwillingness to comply with the study procedures
* Alcohol or drug abuse
* Need to take a non-authorised concomitant treatment (cf. list of medicaments not authorised during the study) in the course of the study
* Other disease requiring treatment with corticosteroids
* Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
* Patient with a hospitalisation scheduled during the study period
* Any uncontrolled concomitant disease requiring further clinical evaluation (e.g. uncontrolled diabetes, uncontrolled hypertension, etc.)
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only

The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.


Eligibility Criteria:
Inclusion Criteria:

* Subjects currently enrolled in study 20050103, 20050136, or 20050244
* Subjects must sign the informed consent before any study specific procedures are performed

Exclusion Criteria:

* Developed sensitivity to mammalian cell derived drug products during the 20050103, 20050136, or 20050244 study
* Currently receiving any unapproved investigational product other than denosumab
* Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
* Subject (male or female) is not willing to use 2 highly effective contraception during treatment and for 7 months (women) or 10 months (men) after the end of treatment
* Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment
* Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
Effects of Brain Stimulation During Daytime Nap on Memory Consolidation in Younger, Healthy Subjects

The beneficial effect of daytime sleep on memory consolidation has been shown in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity typically occuring during SWS has been implicated in the consolidation effect. In this study we investigate if the consolidation effect can be amplified by the application of a weak transcranial oscillatory electric current within the frequency range of SWS in humans (0,7-0,8 Hz) during daytime SWS.


Eligibility Criteria:
Inclusion Criteria:

* healthy Subjects
* unobtrusive, neuropsychological screening
* age: 18-35 years
* right handed

Exclusion Criteria:

* untreated severe internal or psychiatric diseases
* epilepsy
* other severe neurological diseases eg., previous major stroke, brain tumour
* contraindications to MRI
Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles

To investigate the efficacy of dydrogesterone 30 mg compared to micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles, as confirmed by visualization of fetal heart activity by pelvic ultrasound assessment of ongoing pregnancy at 12 weeks of gestation.

A randomized controlled trial comparing dydrogesterone 30 mg versus micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles. Patients will undergo an embryo transfer in a hormone replacement therapy cycle using Progynova 2 mg three times daily until an endometrium thickness of at least 7 mm is reached. Afterwards two different luteal phase supplementation methods will be compared. The primary outcome of the study is ongoing pregnancy at 12 weeks of gestation. We will also investigate other prenatal and neonatal outcome factors as well as patients satisfaction and safety of dydrogesterone.

Eligibility Criteria:
Inclusion Criteria:

* ≤40 years of age at the time of IVF/ICSI treatment
* BMI ≥18 to ≤30 kg/m2 with a documented history of infertility
* Have undergone COS as part of an ART treatment and have had an unsuccessful fresh embryo transfer in that cycle, OR, have undergone freeze all strategy
* Scheduled to undergo FET with a standard exogenous/programmed hormonal replacement therapy (HRT) regimen
* Have at least 1 blastocyst vitrified on the 5th or 6th day after oocyte retrieval
* Elective single embryo (blastocyst) transfer (SET)
* Normal ultrasound examination at enrollment (or if \<12 months old)
* Signed patient authorization for use/disclosure of data.

Exclusion Criteria:

* Women with a history of recurrent miscarriage, defined as \>2 consecutive miscarriages (biochemical pregnancy losses are not included)
* Absence of implantation (serum hCG = negative) after two consecutive cycles of IVF, ICSI or FET where the cumulative number of transferred embryos was \>4 cleavage-stage embryos and \>2 blastocysts
* Presence of hydrosalpinx that is not surgically treated
* Endometrial abnormalities on scanning during ovarian stimulation, such as endometrial polyp(s), sub mucosal fibroid(s), endometrial hyperplasia, endometrial fluid accumulation, or endometrial adhesions
* Participating in another clinical study at the same time
* Known allergic reactions to dydrogesterone or other progestogens products
* Any contraindication or other condition that precludes use of dydrogesterone in a particular patient, in accordance with the precautions listed in the locally approved label
* Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subjects in or to complete the study
* History of prior chemotherapy
* Contraindication for pregnancy
* Transfer of \>1 embryo
A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial

This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S. aureus) bacteremia and SA right-sided infective endocarditis (SA-RIE).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older with at least one blood culture positive for S. aureus within 48 hours before randomization
* At least one of the following signs or symptoms of bacteremia:

  * Temperature ≥ 38.0°C
  * White blood cell (WBC) count \> 10,000 or \< 4,000 cells/µL or \> 10% immature neutrophils (bands)
  * Tachycardia (heart rate \> 90 bpm)
  * Tachypnea (respiratory rate \> 20 breaths/min)
  * Hypotension (systolic blood pressure \< 90 mmHg)
  * Signs or symptoms of localized catheter-related infection
* At enrollment, subjects must have either 1) known right-sided infective endocarditis by Modified Duke's criteria 2) known complicated bacteremia, demonstrated as signs or symptoms of metastatic foci of S. aureus infection or 3) at least one risk factor for complicated bacteremia.

Exclusion Criteria:

* Treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 60 hours within 7 days before randomization. EXCEPTION: Documented resistance to the prior systemic antibacterial therapy
* Presence of an infection source that will not be managed or controlled within the first 3 days of study drug treatment
* Presence of prosthetic cardiac valve or cardiac device (eg, implantable cardioverter defibrillator \[ICD\]), permanent pacemaker, or cardiac valve support ring)
* Known or suspected left-sided infective endocarditis (LIE), by Modified Duke Criteria. NOTE: Right-sided infective endocarditis (RIE) is permitted
* Known or suspected osteomyelitis or meningitis. NOTE: Evidence of metastatic complications related to the primary infection such as right-sided endocarditis, septic arthritis, septic pulmonary emboli are permitted. S. aureus pneumonia is permitted
* Confirmed evidence (identification or gram stain) of a mixed polymicrobial infection with a Gram-negative pathogen that requires non-study antibiotic treatment with agent(s) that have activity against Gram-negative pathogens
AWARE - Chronic Urticaria

Non interventional study collecting patient reported outcomes. The study aims to assess the disease burden of chronic urticaria patients and to record the therapies used in daily clinical practice in the UK and the impact they have on the quality of life and work productivity of individual patients.


Eligibility Criteria:
Inclusion Criteria:

Subjects must be 18 years old Subject must be willing and able to provide written informed consent for collection and analysis of routine data and PROs Subject must have medically confirmed diagnosis of chronic urticaria present for more than 2 months.

Subject must be refactory to at least one H1 antihistamine

Exclusion Criteria:

Subjects who in the estimation of the treating physician are unlikely to be available for the full duration of the follow-up period of 24 months.

Subjects taking must not take part in any other concurrent urticarial study.

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The Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer（NSCLC）

This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years old , male or female
* Pathologically or cytologically proven oligometastatic stage IV NSCLC non-small cell lung cancer（NSCLC）
* Primary tumors can be measured
* Distant organ metastases number ≤ 5
* Karnofsky score \>70,Zubrod performance status 0-1
* Estimated life expectancy of at least 12 weeks
* reproductive age women should ensure that before entering the study period contraception
* Hemoglobin≥10.0g/dL,WBC≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times upper limit of normal,bilirubin normal
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* Patients have good compliance to treatment and follow-up of acceptance.

Exclusion Criteria:

* Allergic to pemetrexed, cisplatin, docetaxel and contrast medium
* Distant metastases organs \> 5
* The primary tumor or lymph node already received surgical treatment (except for biopsy)
* Patient who received radiotherapy for primary tumor or lymph node
* Patient who received the the epidermal growth factor targeted therapy
* Patient who received chemotherapy or immunotherapy
* Patient who suffered from other malignant tumor
* Patient who have taken other drug test within 1 month
* Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period
* Subject with a severe allergic history or idiosyncratic
* Subject with severe pulmonary and cardiopathic disease history
* Refuse or incapable to sign the informed consent form of participating this trial
* Drug abuse or alcohol addicted
* Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct
Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer

The objectives of this study are to evaluate the efficacy and tolerability of high dose proton pump inhibitor combined with chemotherapy in metastatic breast cancer.

High dose proton pump inhibitor (PPI) has been proved beneficial and it improved efficacy when combined with chemotherapy in preclinical and clinical trials.This study was designed to explore whether adding a proton pump inhibitor into docetaxel and cisplatin chemotherapy improves efficacy and does not affect tolerability in metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Female, ≥ 18 years.
* Histologically confirmed invasive breast cancer.
* Metastatic breast cancer.
* Karnofsky Performance Status ≥60.
* Life expectancy of more than 3 months.
* Subject must have adequate organ function.
* Normal laboratory values: hemoglobin \> 80g/dl, neutrophils \> 2.0×10\^9/L, platelets \> 80×10\^9/L, serum creatinine \< upper limit of normal (ULN), serum bilirubin \< ULN, ALT and AST \< 2.5×ULN, AKP \< 5×ULN.
* Negative serum pregnancy test for women with childbearing potential.
* Good conditions for infusion and willing to have phlebotomy throughout whole study.
* Have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy for more than 28 days.
* Have at least one target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* No prior use of docetaxel or has used docetaxel in adjuvant/neo-adjuvant chemotherapy and has a relapse free survival of at least 12 months.

Exclusion Criteria:

* Pregnant or lactating females.
* History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
* Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety.
* Active or uncontrolled infection.
* Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
* Concomitant with brain metastases.
* Have received chemotherapy after metastasis.