cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Urinary Incontinence During Third Trimester of Nulliparous on Pelvic Floor Muscle Training

Comparison of urinary incontinence during third trimester of nulliparous on pelvic floor muscle training in Rajavithi hospital

Outcomes

1. primary outcome \>\> UI at third trimester
2. secondary outcome \>\> quality of life, duration of second stage of labor

   * Inclusion criteria nulliparous GA 20-24 week gestation singleton Age 18-35 years old Can communicate and understand Thai language Cooperating to join research
   * Exclusion criteria DFIU Maternal medical condition or high risk pregnancy such as multifetal gestation, chronic hypertension, pregestational DM, epilepsy, autoimmune disease, polyhydramnios asthma
   * Pre-excisting urinary incontinence
   * prepregnancy BMI\>=30 kg/m2
   * smoking
   * 2 groups study \>\> control and intervention group
   * Both groups were evaluated urinary incontinence(UI) at third trimester with UDI-6 and IIQ-7 questionaires
   * Intervention group was trianed pelvic floor muscle strength and evaluate strength with Brink score by researcher who was trained and tested pelvic floor muscle strength by urogynecologist at day 1 then reassess Brink score at 4 weeks
   * program of pelvic floor muscle training ( PFMT) consist of contract and whole pelvic floor muscle 10 seconds and relaxation 10 second total 20 times per set total 3 set per day
   * intervention group was followed up once a week by telephone about compliance of program, general symptom and notice for self recording sheet
   * PFMT program follow up total 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* nulliparous
* gestational gae 20-24 week
* age 18-35 year
* can communicate and understand Thai language
* co-operate to join research

Exclusion Criteria:

* DFIU
* maternal medical condition or high risk pregnancy such as multifetal gestation , pregestational DM, chonic hypertension , epilepsy, autoimmune disease, polyhydramnios, asthma
* pre-excisting urinary incontinence
* prepregnant BMI \>=30 kg/m2
* smoking
Attain StarFix® 4195 Lead Extraction Study

The purpose of this study is to characterize the removability of the Attain StarFix® Model 4195 Left Ventricular (LV) Lead (StarFix®). The goal of the trial is to evaluate the lead removal success in patients that are indicated for left ventricular lead removal. This study is required by the Food and Drug Administration (FDA) as a condition of approval for the Attain StarFix® Model 4195 LV Lead.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a Class I/II indication and/or physician discretion for left ventricular lead removal
* Medtronic Model 4195 LV lead implanted for at least 181 days at time of extraction, or other Medtronic LV Lead (non-Model 4195) implanted for at least 181 days at time of extraction, or Medtronic Model 4195 LV lead implanted for 90-180 days
* Intention to remove the LV lead prior to the extraction procedure
* Subject is 18 years of age or older
* Subject (or subject's legally authorized representative) has signed and dated the Patient Consent Form and is willing and able to comply with the protocol

Exclusion Criteria:

* None
Study on Mannan Binding Lectin (MBL) Substitution in MBL-Deficient Children With Chemotherapy-Induced Neutropenia

The pharmacokinetics, and clinical and biological effects of MBL replacement therapy in MBL-deficient children during chemotherapy-induced neutropenia were studied.

Mannan Binding Lectin (MBL) is a member of the lectin pathway of the complement system and plays an important role in the innate immune system. MBL replacement in MBL-deficient children with chemotherapy-induced neutropenia represents a new approach to lower the risk of febrile episodes, of hospital admission, of prolonged use of intravenous antibiotics and of severe infections.

The aim of the Phase II study is to find evidence for the correct prediction of plasma levels of MBL necessary for clinical effects and biological efficacy, to confirm the dosage regimen needed to reach the required MBL plasma levels, and reconfirm the safety and lack of side-effects.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 0 - 12 years, during chemotherapy, and expected to become neutropenic
* MBL deficiency by genotype or phenotype (\< 100 ng/ml)
* Informed consent and assent of patient and/or legal representative

Exclusion Criteria:

* Inability or unwillingness to comply with the protocol or likely inability to complete the study period
* Known allergic reactions to MBL and other human plasma products
* Participation in other investigational drug studies within the last month
* Clinically relevant abnormalities in: serum immunoglobulins IgG, IgA, IgM; blood counts; complement factors measured by AP50, CH50; urine protein and cell counts; serum creatinine and liver enzymes, as routinely determined for regular patient care.
Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache

The purpose of this study is to determine the efficacy and tolerability of 500 mg and 1000 mg Aspirin® (study medication) by comparing it to placebo (the control group without active substance) or 200 mg or 400 mg Ibuprofen (study medication) in treating the symptoms of episodic tension-type headache. The study is designed to develop a treatment method against episodic tension-type headache which will have more advantages for patients than the methods that are currently available.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory male or female, 18 to 65 years of age
* Normal blood pressure
* Patients suffering from episodic tension-type headache
* Headache lasting from 30 minutes to 7 days
* Headache had at least two of the following characteristics:

Bilateral location. Pressing/tightening (non-pulsating). Mild or moderate intensity. Not aggravated by routine physical activity such as walking or climbing stairs.

- Both of the following: No nausea or vomiting. No more than one of photophobia or phonophobia.

Exclusion Criteria:

* Other headaches, including migraine, that required medical treatment
* Hypersensitivity to acetylsalicylic acid, salicylates, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)
* Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease
* Mental illness, including depression
* Needed or were using or likely to need or use any of the prohibited concomitant medications: antidepressants, oxicams
* Pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception
* Participating in any other clinical study or had done within the previous 4 weeks
* Had been previously enrolled in this study
Abstinence-Linked Money Management Multisite

Randomized clinical trial comparing a money management-based intervention involving storage and management of client funds, substance abuse counseling, and risk reduction counseling to individualized drug counseling.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in ambulatory psychiatric treatment at one of the participating clinics
* Receives SSI or SSDI payments
* Able to provide written informed consent
* Cocaine use within the last 60 days as evidenced by either a positive toxicology screen or self-reports

Exclusion Criteria:

* Has a conservator of person
* A history of violence towards clinical providers or predatory violence
* Suicidal plans or intent; homicidal plans or intent. Suicidal or homicidal ideation will not be exclusion criteria
* Physiological dependence on alcohol, illicit opiates or illicit sedatives as evidenced by a history of four weeks of daily use of these substances; and either tolerance or withdrawal (as defined by DSM IV-TR). The "standard withdrawal scales" referred to in DSM IV-TR will be the CIWA-AR (Sullivan et al., 1989) and the Clinical Opiate Withdrawal Scale (Wesson and Ling, 2003), with P.I. review because signs on the CIWA-AR such as "aware of sounds around you" may reflect psychiatric illness, not withdrawal
* Will not be able to complete the twelve months of the study because of anticipated incarceration or move
* Had been enrolled in the ongoing study
* Unable to speak and understand English
Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to continue testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's disease after completion of the parent study M15-741.

ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's Disease. Participants who have successfully completed M15-741 study will immediately enter this study's treatment period to continue receiving ABBV-951. Adult participants with advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide.

Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours daily during the Primary Treatment Period and during the optional Extended Treatment Period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular clinic visits and have remote assessments completed via phone calls during the course of the study. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have Parkinson's Disease and who have successfully completed the parent study M15-741.
* Participants willing and able to comply with procedures required in the protocol.

Exclusion Criteria:

- Participants, if judged by the investigator to be unsuitable candidates to continue to receive ABBV-951 for any reason.
IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity

This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of arm tightness (upper limb spasticity) using two different dilutions of incobotulinumtoxinA (Xeomin).

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins. Injected into a muscle, incobotulinumtoxinA causes a reversible local weakening of the muscle for several months, and may improve an impaired muscle function by lessening the muscle tightness within few days. IncobotulinumtoxinA is widely used for various severe neurological conditions. There is some evidence that the treatment effect may be influenced by the amount of the solvent in which incobotulinumtoxinA is diluted before injection.

Eligibility Criteria:
Main Inclusion Criteria:

* Female or male patients ≥ 18 years
* Stable upper limb spasticity of diverse etiology
* Focal spasticity with equal or more than 2 points on the Ashworth scale in the wrist flexors
* Disability Assessment Scale (DAS) ≥ 2 points for primary therapeutic target at both screening and baseline visits

Main Exclusion Criteria:

* Fixed contracture
* Bilateral upper limb paresis/paralysis
* Previous treatment with BoNT of any serotype and for any body region within the 4 months prior to screening
* Previous or planned treatment with phenol- or alcohol-injection in the target limb
* Other muscle hypertonia (e.g. rigidity)
* Diagnosis of myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the study
* Severe atrophy of the target limb muscles
Effectiveness of Combined Neural Mobilization With Manual Myofascial Release for Sciatic Pain Relief

This study will address to evaluate and compare both Neural mobilization and Manual Myofascial Release of piriformis and Lumbar muscles in sciatic pain with the aim of evaluating and identifying the most effective intervention for managing this specific condition, and provide valuable insights into the effectiveness, mechanisms, and practical considerations associated with these interventions, ultimately contributing to evidence based and patient centered care.

MFR is a hands-on technique targeting fascial restrictions that may contribute to pain and reduced mobility. Barnes proposed that releasing fascial adhesions can improve circulation, reduce nerve compression, and enhance tissue flexibility. In a study by Ajimsha et al. , MFR was found to significantly reduce pain and improve physical function in patients with nonspecific low back pain. There is a lack of comparative research assessing the relative efficacy of neural mobilization andMFR in sciatic pain management. While both techniques are rooted in distinct mechanisms neural desensitization versus fascial release they may have overlapping benefits in improving mobility and reducing pain. This study addresses this research gap by directly comparing the two approaches in individuals with sciatic pain.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically diagnosed unilateral sciatic pain for \>3 months.
2. Positive Straight Leg Raise (SLR).

Exclusion Criteria:

- Participants fall in this category would be excluded of the study.

1. Recent spinal surgery or trauma.
2. Neurological deficits or systemic conditions affecting the nervous system.
3. Any other red flags
Tailored Ovarian Stimulation Based on BMI, AMH, AFC

The study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, antral follicle count (AFC).

300 patients will be randomized in 2 arms:

1. control group: standard care rec FSH.
2. study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI and basal AMH level.

Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of rec FSH used.

Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B and AMH levels during ovarian stimulation.

The study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, AFC and inhibin B.

300 patients will be stimulated with rec FSH and an antagonist pituitary inhibition protocol, and randomized (at random computer generated numbers) in 2 arms:

1. control group: standard care recFSH based on age, basal FSH and AFC.
2. study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI and basal AMH level.

FSH administration: 20IU per antral follicle (from 2-5mm) corrected as follows:

Correction factor for

AMH:

\<1 pMol/L X4 1-6 pMol/L X2 7-18 pMol/L X1 \>18 pMol/L X0.5 BMI 16.5-18.5 X0.75 18.5-25 X1 25-30 X1.25 30-35 X1.5 35-40 X2 Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of rec FSH used.

Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B and AMH levels during ovarian stimulation.

Eligibility Criteria:
Inclusion Criteria:

* female infertile patients eligible for IVF treatment

Exclusion Criteria:

* polycystic ovaries
* untreated thyroid pathology
* hypogonadotropic hypogonadism
* untreaed hyperprolactinemia
* study drug hypersensitivity
* previous OHSS
* unilateral ovariectomy
* genital malformation
* BMI\>40
Concurrent Chemoradiotherapy Using Intensity Modulated Radiotherapy (IMRT) & Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer

Primary Objective:

* Response rate (by contrast CT scan)

Secondary Objectives:

* Progression-free survival (PFS)
* Overall survival (OS)

The duration of the study for each patient will include an up to 6-week screening phase, 12 weeks treatment phase (including a resting period of 2 weeks) followed by a long-term follow-up.

Eligibility Criteria:
Inclusion criteria:

* Pathologically proven locally advanced, inoperable, confirmed by PET scan (thorax/ upper abdomen) to be International stage III (2009) NSCLC and without multifocal tumours in the lung
* Disease volume encompassible within a tolerable Planning Target Volume treated to 66 Gy
* FEV1 (Force Expiratory Volume in 1 Second) \>1000 ml
* Hemoglobin ≥ 9.0 g/dl
* Absolute neutrophil count (ANC) ≥ 1,500/mm3
* Platelet count ≥ 100,000/mm3
* Total bilirubin ≥ 1.5 times the upper limit of normal
* ALT (Alanine Aminotransferase) and AST (Aspartate transaminase) ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for patients with liver derangement)
* ECOG (Eastern Cooperative Oncology Group) PS 0-1

Exclusion criteria:

* Previous treatment with chest radiotherapy, chemotherapy or molecularly targeted agents
* Inadequate lung function (Exercise tolerance less than 1 FOS/Fight of stairs, FEV1 \< 1 L/sec, or raised pCO2)
* History of hypersensitivity or contraindication to the study drugs or pre-medications or products formulated in polysorbate 80
* Pregnant or breast-feeding women, or women with child-bearing potential who are not following an effective method of contraception and/or who are unwilling or unable to be tested for pregnancy (either by serum or urine pregnancy test before study entry
* Participation in a clinical trial with any investigational drug used and within 30 days prior to study entry

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study to Assess the Absolute Bioavailability and Pharmacokinetics of Simeprevir (TMC435) Administered as Single Oral Doses of TMC435 and an Intravenous Microdose of [3H]-TMC435 in Healthy Male Patients

The purpose of this study is to evaluate the absolute bioavailability and pharmacokinetics (what the body does to the medication) of simeprevir (TMC435) after administration of single oral doses of 50 mg and 150 mg when administered together with a single intravenous (IV) dose of 100 microgram \[3H\]-TMC435 in healthy male participants.

This is an open-label (all people know the identity of the intervention), sequential (a single group of participants where study medication is administered in a sequence), single-dose study to assess the absolute bioavailability and pharmacokinetics (what the body does to the medication) of single oral doses of 50 mg and 150 mg simeprevir (TMC435) administered together with an intravenous (IV) microdose of 100 microgram \[3H\]-TMC435 in healthy male participants. The study consists of 3 phases, screening phase (21 days prior to administration of study medication), treatment phase, and a follow up phase. In the treatment phase, participants will receive 2 treatments, ie, Treatment A: single oral dose of simeprevir (TMC435) 50 mg followed 5 hours later by a single 10 minute IV infusion of \[3H\]-TMC435 (100 microcurie) 100 microgram; and Treatment B: single oral dose of simeprevir (TMC435) 150 mg followed 5 hours later by a single 10 minute IV infusion of \[3H\]-TMC435 (100 microcurie) 100 microgram. Treatments will be administered in two consecutive treatment periods, first Treatment A in Period 1, followed by Treatment B in Period 2; separated by a washout period (period when the participant is not receiving any study medication) of 7 to 14 days. The follow up will be for 5 to 7 days after end of Period 2. Blood samples will be collected for full plasma pharmacokinetics evaluations; along with urine and stool samples for analysis of total plasma radioactivity. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, liver volume determination, and specific toxicities will be monitored throughout the study. The total duration of the study will be approximately 42 days.

Eligibility Criteria:
Inclusion Criteria:

* Must be healthy on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram, and clinical laboratory tests performed at screening
* Must be non-smoking for at least 3 months prior to screening

Exclusion Criteria:

* History of liver or renal insufficiency
* Have any ferromagnetic medical implants or medical devices that can be de-programmed by strong magnetic fields such as, but not limited to: cardiac pacemakers, implantable cardiac defibrillators, cochlear implants, or insulin pumps
* Had a surgical intervention on brain or eyes or has an intraocular foreign metallic object
* Has a history of anxiety and claustrophobia
Assessment of the Impact of the Return Home of Premature Newborns Less Than 2 Kilos Morbidity/Mortality

The aim of this study is to evaluate the impact of discharge from hospital with a weight of less than 2 kilos.

To do this, the investigator will look at the short-term and long-term outcome of newborns weighing less than 2 kilos who were discharged from the neonatology department at the NOVO hospital between 2012 and 2024.

Prematurity in itself, whether simple or associated with intrauterine growth retardation, continues to be a real public health problem. In addition to gestational age at birth, the presence of co-morbidities can affect the morbidity and mortality of premature babies, as well as the length of hospital stay.

Advances in neonatal care and the involvement and skills of parents in the care of premature infants have led to a considerable reduction in mortality among these patients. According to the latest recommendations published in November 2022 by the WHO, and thanks to changes in the criteria for discharging these patients in recent years, the same applies to low-birthweight infants.

The early and well-planned discharge of premature babies is currently the subject of a great deal of study and research. According to these studies, it has been shown that the essential criteria for this discharge are the physiological capacities and skills of these vulnerable patients (thermoregulation, autonomous feeding and breathing, etc.). Essential care, parental support and home visits by qualified health workers (PMI, HAD, etc.) are also essential.

Premature birth has a real impact on the economic consequences in several countries. Infants small for gestational age had longer hospital stays, were more likely to be admitted to an intensive care unit and were more likely to be hospitalised in the first year of life, resulting in higher costs.

It is against this backdrop that the NOVO hospital is proposing to evaluate the impact of discharging babies weighing less than 2 kilos. To do this, the investigator will base his study on the short-term and long-term outcome of newborns weighing less than 2 kilos who were discharged from the NOVO hospital's neonatology department between 2012 and 2024.

Eligibility Criteria:
Inclusion Criteria:

* Premature newborn baby (born at less than 37 days' gestation)
* Newborn baby with IUGR (Intra-Uterine Growth Retardation)
* Newborn baby hospitalised in the neonatology department of the NOVO hospital - Pontoise site
* Patient born between 01/01/2012 and 31/12/2024.
* Newborn who has left the neonatology department or the Kangaroo Unit to return home weighing less than 2 kg.
* Newborn beneficiary of a social security scheme or entitled person.

Exclusion Criteria:

* Newborn transferred to another hospital before discharge.
* Refusal by one of the parents.
* Parent does not speak or understand French.