cyrilzakka/clinical-trials huggingface dataset:
A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears

Long-term results after obstetric anal sphincter tears (AST) is poor. The investigators aim to improve the long-term outcome after AST in terms of symptoms of anal incontinence.

A prospective study at, Malmö University Hospital. Twenty-six women with at least grade 3B AST were classified and sutured in a systematic way, including separate suturing of the internal and external sphincter muscles with monofilament absorbable sutures. The principal outcome was a difference in anal incontinence score, based on six questions, between the study group and two control groups (women with prior AST \[n = 180\] and primiparous women delivered vaginally without AST \[n = 100\]).

The series was undertaken in advance of a planned prospective randomized controlled study. The study was approved by the Research Ethics Committee of Lund University and informed consent was obtained from all the women involved. Twenty-six women presenting with at least a 3B rupture were recruited by one of the two surgeons (MJ, PL). The modified technique included:

1. Adoption of a structured way of describing the damage according to Fornell an co-workers\[7\] and recommended by RCOG.\[8\] Grade 3A: any tear of the ESM \< 50% Grade 3B: an ESM tear \> 50% Grade 3C: related damage to the ISM Grade 4: related rupture of the anal mucosa
2. The use of monofilament resorbable suture material for all sutures in the mucosa or sphincter muscles. The anal mucosa was sutured with a continuous layer of 3.0 glycomer 631 (Biosyn® ,Tyco Healthcare, Mansfield, MA, USA); the ISM with a continuous layer of 3.0 glycomer 631; and the ESM (both superficial and profound portions) with interrupted end-to-end 2.0 glycomer 631 sutures. The perineal body was usually sutured with 2.0 or 3.0 lactomer (Polysorb®, Tyco Healthcare, Mansfield, MA, USA).
3. Metronidazole 1.5g as a single IV injection and/or Cefuroxime 1.5g IV during the procedure and 6 hours post-operative was usually given as prophylaxis.
4. All women were sutured under either regional anaesthesia (spinal, epidural, or pudendal) or general anaesthesia. Thus, the modified procedure included both a new technique of suturing and the operation was performed by one of the two surgeons involved in the study. Apart from this, all women were treated according to routine departmental practice.

Eligibility Criteria:
Inclusion Criteria:

* Sphincter tear \> grad 3B

Exclusion Criteria:

* No
Zonisamide in the Treatment of Essential Tremor

The purpose of this study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor.

The subjects will remain on their usual medication and a baseline assessment using the Fahn Tolosa Marin tremor rating scale will be performed and will be video taped.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Essential Tremor based on the Tremor Investigational Group criteria for definite or probable Essential Tremor.
2. Age: 18 years or over.
3. Willingness and ability to comply with the study requirements and give informed consent.

Exclusion Criteria:

1. Known history of psychiatric disorder, major depression, dementia, aplastic anemia, or Stevens-Johnson syndrome.
2. Known alcohol or substance abuse in previous 12 months.
3. Positive pregnancy test.
4. Unwillingness to use adequate contraceptive methods if of childbearing potential.
5. Known allergy to sulfonamides.
6. Laboratory abnormalities prior to onset of trial.
GnRH Agonist Pretreatment in Hysteroscopic Myomectomy

The primary outcome of this study is to assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure. Moreover, we will investigate the intraoperative influence of such pharmacologic therapy in terms of distension liquid absorption and duration of the procedures.


Eligibility Criteria:
Inclusion Criteria:

* submucous myoma diagnosed by vaginal ultrasonography and confirmed by diagnostic hysteroscopy
* premenopausal status

Exclusion Criteria:

* present or past history of cancer
* pregnancy
* presence of associated multiple polyps
* presence of \> 2 myomas
* associated nonhysteroscopic surgical procedures
ACT-128800 in Psoriasis

This study will assess the efficacy, safety, and tolerability of ACT-128800 in subjects with moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females with moderate to severe plaque psoriasis who require systemic treatment and for whom participation in a placebo-controlled study of an investigational drug is justified.

Exclusion Criteria:

* Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than psoriasis.
* Systemic or topical treatments for psoriasis other than emollients.
* Ongoing bacterial, viral or fungal infections.
* History or presence of malignancy.
* Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.
Differential Diagnosis and Risk Stratification in Patients With Suspected NSTEACS

To evaluate possibilities of rapid differential diagnosis and risk stratification in patients urgently admitted to the CCU with a suspected acute coronary syndrome without persistent ST-segment elevation (NSTEACS).

Single centre prospective non-randomised non-comparative study of patients delivered by ambulance and admitted to the CCU with suspected NSTEACS.

Aims of this study are:

1. To characterize the contingent of patients admitted to the CCU with suspected NSTEACS.
2. To evaluate possibilities of fast differential diagnosis and risk stratification in patients admitted to the CCU with suspected NSTEACS using clinical data, ECG, biomarker levels (hsTn, NT-proBNP, hsCPR, cardiac FABP) as well as HEART, ADAPT, EDACS, T-MACS, GRACE, ACTION and TIMI scores.
3. To evaluate the correlation between clinical data, ECG, biomarker levels (hsTn, NT-proBNP, hsCPR, cardiac FABP) as well as HEART, ADAPT, EDACS, T-MACS, GRACE, ACTION and TIMI scores with presence and severity of coronary atherosclerosis in patients admitted to the CCU (intensive care unit) with suspected NSTEACS.

Eligibility Criteria:
Inclusion Criteria:

1. Delivered by ambulance to the CCU with suspected diagnosis "acute coronary syndrome (ACS)".
2. Signed informed consent.

Exclusion Criteria:

1. ACS with persistent ST-segment elevation.
2. Moribund; extremely severe condition on admission with a potentially unfavourable prognosis (cardiogenic shock, coma, cardiac arrest, an urgent need for mechanical ventilation).
3. Overt non-cardiac cause of clinical manifestations at the time of admission (bleeding, pulmonary embolism, aortic dissection, stroke).
Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Smoking (Trial 1)

The study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. During the Intake, detailed consent and eligibility assessment will be completed. Participants who are eligible at the Intake will be randomized (within site and Intake Group) to R or IP Treatment and Assessment Groups. Participants will be followed for 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Common to all 3 RCTs:

Inclusion criteria:

1. age \>18 years
2. stable mailing address (for mailing study packets if assigned to Remote Intake and/or Remote Treatment/Assessment) within accessible range of each study site
3. able to read, speak \& verbally comprehend English
4. own an iOS or Android smartphone
5. have a valid e-mail address that is checked regularly or have regular access to text messages (to access follow-up assessments)

Specific to RCT 1:

Inclusion criteria:

1. daily cigarette smoker of \>5 cigs/day
2. moderate or greater motivation to quit smoking (6+ on the Motivation to Stop Smoking Scale63
3. willingness to use dual NRT to quit
4. agree to refrain from use of other tobacco products and use of non-study cessation treatments while participating in the trial

Exclusion Criteria:

* Specific to RCT 1:

  1. use of tobacco/nicotine products other than cigarettes more than once per week
  2. prior allergy/intolerance to NRT patch or lozenge
  3. FDA-specified contraindications for use of NRT
  4. use of tobacco/nicotine products other than cigarettes more than once per week
  5. prior allergy/intolerance to NRT patch or lozenge
  6. FDA-specified contraindications for use of NRT
  7. . pregnant, breastfeeding, or planning to become pregnant
  8. self-reported recent (past 1 month) cardiovascular event: MI, stroke
  9. current use of any smoking cessation medication or antipsychotic medication
  10. daily/near-daily binge drinking or alcohol dependence (NIDA Quick Screen; AUDIT\>15)
  11. high risk involvement with illicit or nonmedical prescription drugs (NIDA-modified ASSIST\>=27)
  12. past-year suicide attempt
  13. active and unstable major medical/psychiatric conditions
A Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men

This study is being conducted to provide initial safety, tolerability, PK and PD data that will allow further studies with darapladib in Japanese patients


Eligibility Criteria:
Inclusion criteria:

* Japanese males, 20-64 years of age, inclusive
* Body weight \>50Kg
* Body Mass Index (BMI): 18-28
* Subjects must have lived outside of Japan no more than 10 years
* Non-smoker or smokes fewer than 10 cigarettes/day

Exclusion criteria:

* History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses
* History of sensitivity to heparin or heparin-induced thrombocytopenia
* History of alcohol/drug abuse or dependence within 12 months of the study
* Positive syphilis, HIV antibody, Hepatitis B, Hepatitis C
* History of cholecystectomy or biliary tract disease or history of liver disease
* Participation in a clinical study within 30 days prior to first dose
* Subject has been exposed to more than 4 chemical entities within 12 months
* Positive urine drug and alcohol at screening
* Subject has any medical history or clinically relevant abnormality that would make the subject ineligible for inclusion due to safety reasons.
0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children

The primary objective of this study is to compare the mean serum sodium at 48 hours following the initiation of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in children requiring maintenance IV fluid administration.

Hyponatremia, has become increasingly recognized as a cause of morbidity and mortality in hospitalized children. The main etiology of hyponatremia in these children has been attributed to the use of hypotonic maintenance IV fluids. The practice of providing IV solutions containing 20-30 mmol/L of Na is based on "physiological needs" proposed by Holliday and Segarin 1957, derived from studies of 61 adults and children. The presence of non-physiologic ADH secretion in the great majority of hospitalized children due to nausea, stress, pain, and surgical interventions, has confirmed that Holliday and Segar's recommendations are frequently inappropriately applied. To avoid the development of hyponatremia, it has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance IV solution.

The routine use of an isotonic maintenance fluid solution has not yet been studied, and concerns exist regarding the potential for hypernatremia and salt and water overload. If isotonic solutions are to be recommended routinely, their overall safety, and specifically the occurrence of dysnatremias and volume overload, should be evaluated in a controlled prospective trial.

Eligibility Criteria:
Inclusion Criteria:

* Aged 1 month to 18 years
* Anticipated hospitalization \>48 hours
* Initial plasma Na between 135-145 mmol/L, with a management plan(determined by the responsible physician) to include IV fluids at \> 80% of maintenance
* For children who have had an IV saline bolus, it must have been completed three or more hours prior to having baseline bloods
* Baseline bloods must be drawn within 3 hours of initial patient contact.

Exclusion Criteria:

* Diagnosed with, or clinically suspected to have, any of the following: dehydration/gastroenteritis, heart or liver failure, portal hypertension with ascites, metabolic disease, SIADH, diabetes insipidus or mellitus, hypertension, adrenal insufficiency, renal failure \[creatinine\>100 μmol/L (\<3 years); \>150 μmol/L (\> 3 years)\], nephritic or nephrotic syndrome, Kawasaki disease, Sickle cell disease if requiring hyperhydration.
* Clinically edematous
* On diuretic medications
* Plasma glucose is \>15 mmol/L
* Require CCU admission
* Any patients requiring IV maintenance therapy having conditions/diseases not listed as excluded are eligible to be in this study
Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance

This study aimed to evaluate the efficacy and safety of third-generation EGFR-TKI plus anlotinib as maintenance after chemotherapy plus immunotherapy in advanced NSCLC with small cell transformation after EGFR-TKI resistance.

This prospective interventional clinical study aims to evaluate the efficacy and safety of third-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4-6 cycles of chemotherapy and immunotherapy in patients with advanced NSCLC who developed small cell transformation after EGFR-TKI resistance.Approximately 30 non-small cell lung cancer patients who developed small cell transformation after EGFR-TKI resistance were enrolled and treated with 4-6 cycles of chemotherapy plus immunotherapy followed by maintenance therapy with third-generation EGFR-TKI combined with anlotinib.The study is expected to commence recruitment in mainland China in about November 2024. It is expected that the trial will end in December 2026.

Eligibility Criteria:
Inclusion Criteria:

* 1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
* 2. Age ≥ 18 years.
* 3. Histopathology is confirmed non-small cell lung cancer .
* 4.Patients with advanced non-small cell lung cancer (NSCLC) who experienced small cell transformation after EGFR-TKI resistance.
* 5. Predicted survival ≥ 12 weeks. .
* 6. ECOG 0-2.
* 7. Adequate bone marrow hematopoiesis and organ function.

Exclusion Criteria:

* 1. History of other malignant tumors within 2 years.
* 2. Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
* 3. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
* 4. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
* 5. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
* 6. Heart-related diseases or abnormalities
* 7. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
* 8. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
* 9. Live vaccine was given 2 weeks before the first medication.
* 10. Women who are breastfeeding or pregnant.
* 11. Hypersensitivity to the test drug and the ingredients.
* 12. Other conditions assessed by the investigator to be unsuitable for participation in the study.
Effects of Remote Exercise on Physical Function in Pre-Frail Older Adults

This study aims to compare the effects of remote versus in-person exercise interventions on physical function, balance, gait stability, and fall efficacy in pre-frail older adults aged 65 years and above. Participants are randomly assigned to either a remote exercise group, an in-person exercise group, or a control group. The exercise intervention includes balance, strength, and gait training conducted twice weekly for eight weeks. The control group receives educational materials on physical activity. The primary outcome measures include assessments of balance, lower limb strength, gait ability, and fall efficacy. This study seeks to determine if remote exercise is as effective as in-person exercise in enhancing physical function in pre-frail older adults, potentially providing a feasible alternative to traditional in-person programs and addressing barriers such as limited mobility and access to exercise facilities.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Classified as pre-frail based on Fried's frailty criteria (meeting at least two out of five specified indicators)
* Experienced a fall in the preceding six months or have impaired gait and balance (TUG ≥ 13.5 seconds, BBS ≤ 45)
* Mini-Mental State Examination (MMSE) score of 24 or higher
* Demonstrate the physical capacity to engage in the remote exercise (e.g., ability to stand from a seated position and walk short distances)

Exclusion Criteria:

* Neurological or musculoskeletal conditions that impede physical activity
* Recent history of severe cardiovascular disease (within the past three months)
* Inability to commit to continuous participation throughout the study period
* Any other medical condition that might interfere with the intervention or pose a risk to the participant
Evaluation of the Periotest Method in Dental Traumatology

Background/Aims: The Periotest® method represents a technique for objective tooth mobility assessment. The aims of this study were: 1. receiving information about normal Periotest® values in vertical and horizontal dimension on periodontally healthy teeth for individuals aged 20-35, 2. investigating the reliability of the Periotest® method in terms of intra-serial and inter-serial reproducibility before splinting and with an applied dental trauma splint, 3. evaluating the splint effect of two different wire-composite splints in vivo.

Materials and Methods: On periodontally healthy dental students (n=33; mean age 24.7 years) Periotest® values were measured on reproducible measuring points, in vertical and horizontal dimension and before splinting and after splint insertion. Three readings were taken per serial to observe the intra-serial reproducibility, and for testing inter-serial reproducibility three serials were measured (Friedman-test; P ≤ 0.001). Two different wire-composite-splints (1 = Dentaflex 0.45 mm, 2 = Strengtheners 0.8x1.8) were inserted, the Periotest® values were measured and the splint effects were calculated and compared (Whitney-Mann-U-test; P ≤ 0.001).


Eligibility Criteria:
Inclusion Criteria:

* age 19-36
* healthy upper front teeth

Exclusion Criteria:

* periodontal disease
* orthodontic treatment during the investigation period
* history of dental trauma
* fillings or restorations on upper front teeth
* endodontically treated teeth
Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer

This study investigates the medical and psychosocial consequences of colorectal cancer on adolescents and young adults. Measuring physical function in adolescents and young adults with colorectal cancer may help doctors better understand the level of physical function during cancer treatment and how to improve the management of colorectal cancer in adolescents and young adults. This study may also help design a future exercise program to decrease risk factors including high blood pressure, high blood sugar, and high cholesterol.

PRIMARY OBJECTIVES:

I. To prospectively characterize the symptom burden and assess the health-related quality of life of adolescents and young adults (AYAs) in active treatment for colorectal cancer in comparison to older patients to identify differences that contribute to the development of appropriately timed, age appropriate interventions.

II. To characterize the symptom burden and assess the health-related quality of life of AYAs who have completed curative therapy and are in surveillance for colorectal cancer compared to older patients to identify differences that contribute to the development of appropriately timed, age-appropriate interventions.

SECONDARY OBJECTIVE:

I. Using a prospective and cross-sectional design, characterize physical function, body composition, and biomarkers of comorbid conditions among AYAs with colorectal cancer (CRC) on active therapy and after completion of therapy in survivorship to identify targets for and timing of interventions.

EXPLORATORY OBJECTIVE:

I. To assess across Aims differences by cancer site (colon versus \[vs.\] rectal) by sex, and by race/ethnicity.

OUTLINE:

Patients on active treatment complete questionnaires and undergo collection of blood samples and physical function assessments at baseline, and at 3 and 6 months. Survivors in surveillance complete questionnaires and undergo collection of blood sample and physical function assessment at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of colorectal cancer (any stage)
* Any type of prior therapy
* Age \>= 18-39 years for AYA/young adult sample, age 40+ for older comparison group
* For patients on active therapy: must have been diagnosed within the past three months. For survivors: must have completed curative therapy and are 6-24 months post-diagnosis
* Speak English or Spanish
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients who are more than 3 months from diagnosis, and survivors who are more than 24 months from initial diagnosis
* Patients who have a life expectancy of less than 6 months per their medical oncologist
* Patients who are deemed too ill or unable to participate by their medical oncologist (e.g., have cognitive impairment or brain metastases)
* Patients who do not speak English or Spanish
Meditation and Education That is Nurse Delivered for Symptom Management in Paroxysmal Atrial Fibrillation (PAF)

The aim of this project is to determine whether the entire intervention (Mindfulness meditation, AF education, and weekly phone visits) that is nurse delivered to individuals with paroxysmal atrial fibrillation is more effective than a combination, single or no intervention in the reduction of overall AF symptoms, anxiety, and negative illness perception; or the improvement of quality of life (QOL) and functional status.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals with Symptomatic Paroxysmal Atrial Fibrillation
2. A symptomatic episode of PAF within last 6 months
3. 18 years old or greater
4. Able to read and understand English
5. Able to participate in weekly phone calls
6. Able to attend two video visit/phone sessions that are 6 weeks apart

Exclusion Criteria:

1. Diagnosed with low cardiac function (NYHA Class IV)
2. Life expectancy of less than 6 months
3. Hospitalized in prior 3 months for illness other than PAF
4. Previously practiced mindfulness
5. Cognitive impairment