cyrilzakka/clinical-trials huggingface dataset:
Assessment of a Special Modality of Back Muscles Strengthening for Postural Deformations in Parkinsonian Patient

Parkinson's patients have postural disorders. These disorders are frequent in Martinique. Physiotherapeutic rehabilitation is essential because these disorders are generally non dopa-sensitive.

Postural disorders are very common in Martinique, in patients often having an atypical form of the Parkinson's disease. Physiotherapy rehabilitation is essential because these disorders are generally non-dopa-sensitive. Isokinetic muscle strength may reduce postural disorder in Parkinson's disease.

Isokinetic device rehabilitation promotes maximum muscular contraction at constant speed; the resistance of the machine continuously adapting to the force developed by the subject. As the spinal muscle strength gain is superior to conventional post-rehabilitation motor function, the improvement in postural instability should be greater than that achieved with conventional rehabilitation. A better postural support should thus result in a decrease in the risk of falling and an improvement in the quality of walking.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Parkinson's disease or atypical parkinsonian syndrome
* Age ≥18 years
* Patient with postural disorders with a cervical arrow\> 6cm in the sagittal plane and / or the axis C7S2 different from 0 in the frontal plane
* UPDRS between 10 and 25/108.
* Antiparkinsonian treatment stabilized for 8 weeks
* MMS test\> 25
* Insured person or beneficiary of social security

Exclusion Criteria:

* Patient with a neurological condition other than parkinsonian syndrome
* Patient with rheumatic disease
* Patient with a history of trunk surgery
* Patient with a brain stimulator
* Cardiac pathology not stabilized
* Incapacitated adult, or under guardianship, or under curatorship or under judicial protection curatorship
T21,18 and 13 Screening by Cell Free Fetal DNA in Low Risk Patients

The purpose of this study is to evaluate the performance of non invasive screening in a population of pregnant women with and without in vitro fertilisation (IVF) concomitantly to regular first trimester trisomy 21 (T21) screening using maternal age, nucal fold measurement and serum screening.

All pregnant women in 9 institutions in France will be offer both regular first trimester screening for trisomy 21 (T21) and cell free DNA non invasive (NI) screening test at the same time. Specificity and the positive and negative predictive values of the NI test will be analysed. The population will be divided in women who did and did not get pregnant after an In vitro fertilisation (IVF) procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Singleton pregnancy
* Having a spontaneous pregnancy or obtained by AMP ,
* Having chosen to carry out a screening of the T21 to the first or second trimester of pregnancy ,
* Gestational age \>=10 weeks of amenorrhea
* Consenting to invasive prenatal diagnosis,
* Having health insurance,
* Having signed the informed consent

Exclusion Criteria:

* The Patients whose fetus has an abnormality on the first trimester ultrasound including nuchal translucency \> 3.5mm ,
* Participant to another biomedical research.
* Pregnancy twins including the presence of a twin vanishing
The OBSTACLE Hypoglycemia Study (MK-0000-158)

This study will assess the correlation between glycemic control and the hypoglycemia symptom score in patients with Type 2 diabetes, 12 weeks after addition of a sulfonylurea to an ongoing regime of oral hypoglycemic agents.

Patients will be evaluated for participation in the study during their usual visit to participating diabetes care clinics. Addition of sulfonylurea will be an unbiased decision of the participating physicians based on the clinical needs of the participating patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes, of either gender and aged between 18-75 years
* Patients being considered for addition of Sulfonylurea on background of at least one other oral hypoglycemic agent, on a usual visit (screening cum enrolment visit), as per the clinical situation judged by participating physician
* Willing to comply with study requirements

Exclusion Criteria:

* Patients with type 1 Diabetes or gestational Diabetes
* Patients currently on insulin therapy or have received Insulin in last 6 months
* Patients currently on Sulfonylurea therapy or have received Sulfonylureas in last 6 months
* Patients currently on Meglitinides therapy or have received Meglitinides in last 6 months
* Patients initiated on Sulfonylurea monotherapy
* Patient on DPP-4 inhibitors, either as monotherapy or as combination therapy
* Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
* Patients for whom it would be impossible to complete the questionnaire for whatever reason, in any feasible form
* Patients who are already participating in a clinical trial or other clinical study
Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU

The pharmacokinetics of antimicrobials is profoundly modified in Intensive care unit (ICU) patients. To adapt the treatment, it is recommended to measure blood levels of antibiotics. Some antibiotics, such as amikacin, are easy to monitor, while for other molecules, such as piperacillin/tazobactam, the drug monitoring is more difficult to obtain. These two molecules have similar physicochemical characteristics (hydrophilicity) and therefore have closed pharmacokinetic properties. OPTIMA is a study aiming at criteria will be used to judge whether the pharmacokinetic (PK) parameters of amikacin are predictive of those of piperacillin and tazobactam.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Patient hospitalized in the critical care department of the Lyon-Sud hospital centre
* Patient with a sepsis or a severe sepsis table defined by the latest international recommendations
* Patient to be treated by the amikacin + piperacillin/tazobactam association
* Patient affiliated to a social security system, having agreed to participate in the study

Exclusion Criteria:

* Patient with a known history of hypersensitivity or contraindication to amikacin, piperacillin or tazobactam
* Patient known to have previously received piperacillin/tazobactam or amikacin combination before inclusion
* Patient treated at the time of inclusion with dialysis techniques
PRISMA Maternal and Newborn Health Study

Access to quality antenatal care (ANC) and postnatal care (PNC), including maternal, newborn, and infant services, is integral to reducing adverse pregnancy-related health outcomes and promoting positive birth experiences. The World Health Organization (WHO) recommends a total of eight ANC visits for pregnant women. However, the ANC coverage rate remains considerably lower among more vulnerable populations, and the quality of care that women receive is inconsistent, often poor, and frequently fails to detect risks in a timely fashion or adequately prepare women for the birth process. While rates of facility-based delivery are on the rise worldwide, disparities persist and the quality of care across facilities remains uneven. Even less information is available on PNC, where services beyond routine immunizations may not be widely available, especially in resource-poor regions.

Additionally, limited evidence exists on innovative service delivery approaches and how to effectively scale tested maternal and newborn health (MNH) interventions. This coupled with the fragmented datasets from smaller studies limit our ability to advocate for policy change.

The Pregnancy Risk Stratification Innovation and Measurement Alliance (PRiSMA) is implementing a harmonized open cohort study that seeks to evaluate pregnancy risk factors and their associations with adverse pregnancy outcomes, including stillbirth, neonatal mortality and morbidity, and maternal mortality and severe morbidity. The goals are to develop a harmonized data set to improve understanding of pregnancy risk factors, vulnerabilities, and morbidity and mortality and to estimate the burden of these risk factors and outcomes in LMICs. Ultimately, these data will inform development of innovative strategies to optimize pregnancy outcomes for mothers and their newborns.


Eligibility Criteria:
A woman who meets the following inclusion criteria during screening may be enrolled:

* Lives within the study catchment area;
* Meets minimum age requirement in study site country:

  * Ghana: 15 years of age;
  * Kenya: 18 years of age or those who meet the criteria of emancipated minors;
  * Pakistan: 15 years of age or those who meet the criteria of emancipated minors;
  * Zambia: 15 years of age;
  * India: 18 years of age
* Intrauterine pregnancy \<20 weeks gestation verified via ultrasound;
* Provides informed consent.

A woman who meets the following exclusion criteria during screening may NOT be enrolled:

* Nonviable (e.g. ectopic or molar) pregnancy;
* Plans to relocate outside of the study catchment area during pregnancy and/or postpartum.
Neck Cooling as a Non-Invasive Method to Lower Brain Temperature in Healthy Adults

The objective of this study was to clarify whether neck cooling can be used to non-invasively lower brain temperature in healthy adults.

Healthy adults were randomized to undergo an intervention in which either cold or body-temperature water was circulated through an adhesive wrap applied to the front of their necks, overlying the carotid arteries, for 120 minutes. After their first intervention, subjects crossed over (i.e., cold went to body-temperature, and vice-versa) on a separate day. Brain temperature was measured in one-minute intervals using MR thermometry.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18-65 years

Exclusion Criteria:

* Pregnancy
* Contraindications to MRI (e.g. claustrophobia, metallic implants, etc.)
* Signs of ulcerations, burns, hives or rash where the neck wrap is applied
* History of Raynaud's disease, venous or arterial occlusive disease (e.g. carotid stenosis), cryoprecipitation disorders (e.g. cryoglobulinemia) and pernio (also known as chilblains)
Prenatal Antibiotics and Breast Milk / Neonatal IgA

In this biological study, the investigators will evaluate the levels of breast milk IgA, neonatal fecal IgA, and the composition of breast milk and fecal microbiota throughout the first 12 months of life in neonates born to mothers treated or not treated with prenatal antibiotics for at least 7 days after the 32nd weeks of gestation

In a human cohort of women and their neonates, the investigators aim to evaluate the absolute amount of IgA in maternal breast milk and in neonatal feces in the presence (N=41 mother/infant pairs) or in the absence (N=41 mother/infant pairs) of exposure to prenatal ABX during the last period of pregnancy. Moreover, the investigators aim to evaluate, both in maternal breast milk and in neonatal feces, the composition of microbiota, and the proportion and composition of the IgA-coated and not-IgA- coated fractions of microbiota, by means of fluorescence-activated cell sorting (FACS) coupled with 16S rRNA sequencing of bacteria. Finally, the investigators will measure the concentration of the chemokine CCL28 on maternal serum and breast milk, as a soluble marker of activity of the entero-mammary pathway that is known to drive the migration of IgA producing plasma- cells from maternal mesenteric lymph nodes to the mammary gland.

All the analysis will be performed in mother-infant dyads with exclusive breastfeeding. Breast milk/serum/feces collection and analysis will be repeated at the following timepoints:

1. during the first week of neonatal life
2. at 1 month of life
3. at 3 months of life
4. at 8-12 months of life (or at the time of breastfeeding interruption), after the introduction of solid food in the infant's diet.

Eligibility Criteria:
Inclusion Criteria:

* expression of written informed consent
* an antibiotic treatment (any molecule) for at least 7 days consecutively after the 32 weeks of pregnancy (or the absence of exposure to any systemic antibiotic treatment during pregnancy for the control group)
* the intention to breastfeed their neonates as long as possible during the first year of life

Exclusion Criteria:

* absence of written informed consent
* the intention to formula feed exclusively (or the presence of significant maternal concerns about breastfeeding)
* a maternal antibiotic treatment shorter than 7 days
* the presence of pre-existing maternal immune-mediated disorders (including immunodeficiencies and chronic infectious diseases)
* a delivery at a gestational age \< 34 weeks
* the administration of antibiotics to neonates after birth, within the first week of life.
Efficacy of Telemetry-assisted Care in Home Home Vented COPD

This study in patients suffering of Chronic Obstructive Pulmonary disease (COPD) aims to investigate whether telemonitoring of their non invasive ventilation (NIV) device together with targeted, tailored intervention in case of increasing symptoms or ventilation abnormalities improves the therapy adherence and effectiveness and can reduce the need for hospitalizations.

54 NIV naive COPD patients will be randomized to either telemonitoring care with a data-based intervention scheme or standard care according to the guideline of the German Society of Pneumology.

Primary objective:

Adherence to ventilation in the intervention group versus control group.

Secondary objective:

Comparisons between the control and intervention groups, over time and against each other, in terms of:

* Health-related quality of life assessed by SGRQ
* Symptomatology based on blood gas analyses, CAT score, mMRC score and S3-NIV score
* Therapy quality according to therapy parameters from device data
* Number of hospitalizations and physician visits
* Evaluation of the impact of feedback and interventions on therapy adherence, symptomatology and therapy data.

Eligibility Criteria:
Inclusion Criteria:

* NIV-naive / Continuation after 3 Months Interruption
* Indication for initiation of NIV according to S2k guideline of the German Society of Pneumology
* Presence of the signed informed consent

Exclusion Criteria:

* Absence of signed written informed consent for data protection and study participation.
* contraindication to PAP therapy
* Participation in another study that influences the setting of NIV therapy through specifications regarding device settings or titration
Comparing Short-term Function and Pain After No Treatment or Splinting for Boxer's Fracture

This Study is being done because the investigators would like to know if pain and hand function after having a boxer's fracture differs between being treated with supportive splinting or without splinting, but with behavioral modifications.

After initial treatment in the emergency department, patients with boxer's features are referred to the division of plastic and reconstructive surgery at Sunnybrook hospital. During initial consultation with the hand surgeon, treatment is chosen. Patients are follow-up with their hand surgeon at 4-, 8-, and 12--week intervals.

Supportive splinting: Patient's are given a removable plaster/fiberglass splint with a tensor bandage underneath.

Behavioral Modifications: Patients are not splinted, but provided a tensor bandage. Patients are instructed on specific behaviours to prevent movement of the injured part of the hand.

The purpose of the study is to compare pain and short-term hand function in patients who undergo supportive splinting compared to patients who undergo behavioral modifications treatment only to see which option is associated with shorter functional recovery and which option is associated with less pain during the first 4 weeks after initial treatment.

On follow-up appointments at 4, 8,and 12 weeks, as well as initial consultation with the hand surgeon, participants will be asked to perform a grip strength test with a Jamal Hydraulic hand Dynanometer. Participants will be asked to fill out a Brief Michigan Hand Questionnaire along with the grip strength test as well as quick demographics survey at initial consultation with the hand surgeon. After the 12-week follow up appointment, study participation will end.

If a patient is unable to follow-up with the hand surgeon, the Brief Michigan Hand Questionnaire will be done via phone whenever is most convenient for the patient. It's anticipated that about 40 people will participate in this study at a single centre in Toronto.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of true boxer's fracture
* Candidate for either supportive splinting or tensor bandage
* Speaking, read and write English

Exclusion Criteria:

* Prior surgical treatment for boxer's fractures or other hand conditions.
* Concurrent hand/wrist injury
SGM-101 in Locally Advanced and Recurrent Rectal Cancer

Near-infrared fluorescence-guided oncologic surgery (EGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness, which can be difficult to detect with conventional visual and tactile feedback. Hence, this information could aid in intra-operative decision making and therewith foster complete resection margins and less extensive surgery. Subsequently, this may drastically improve patient care by improving oncologic outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged over 18 years old;
2. All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
3. Patients should be scheduled and eligible for surgery because of a clinical diagnosis of T3 with a threatened CRM or T4 rectal cancer (locally advanced) or recurrent rectal cancer. (UICC. TNM classification of diseases for oncology. 3rd ed. Geneva: World Health Organization; 2000)
4. Patients should be capable and willing to give signed informed consent before study specific procedures.

Exclusion Criteria:

1. Other malignancies, either currently or in the past five years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma.
2. Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery)
3. Patients with a recent history (within the last 3 years) of other distant metastases (even those diagnosed during surgery)
4. Patient with a history of a clinically significant allergy.
5. Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential;
6. Laboratory abnormalities defined as:

   1. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
   2. Total bilirubin above 2 times the ULN or;
   3. Serum creatinine above 1.5 times the ULN or;
   4. Platelet count below 100 x 109/L or;
   5. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
   6. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;
7. Any condition that the investigator considers to be potentially jeopardizing the patients' well-being or the study objectives.
8. Previous administration of SGM-101
MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms

The primary objective of this study is to determine the efficacy of both low-dose oral (by mouth) 17-ß-estradiol and the non-hormonal drug venlafaxine XR compared to placebo in reducing hot flashes. Included in this objective is the intention to compare venlafaxine XR to estradiol therapy, to provide evidence of the relative efficacy of venlafaxine to what is currently considered the most established but also a controversial therapy. 17-ß-estradiol is a type of estrogen. Venlafaxine XR is the extended release (XR) version of venlafaxine. Venlafaxine XR is an serotonin-norepinephrine reuptake inhibitor (SNRI). A placebo is a substance containing no medication.

The MsFLASH-03 study (Menopausal Strategies: Finding Lasting Answers for Symptoms and Health - 03), Comparative Efficacy of Low-Dose Estradiol and the SNRI Venlafaxine XR for Treatment of Menopausal Symptoms, is a randomized, double-blind, placebo-controlled, three arm clinical trial. The design includes: 3 weeks of daily recording of hot flashes prior to drug treatment; 8 weeks of double-blind treatment with oral estradiol, venlafaxine, or placebo; followed by 14 days of drug taper for those on venlafaxine and 14 days of progesterone treatment for those on estradiol; followed by 2 weeks with no treatment for all groups; and a telephone follow-up post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 40-62 years
* Postmenopausal or perimenopausal
* Having bothersome hot flashes
* In general good health
* Signed informed consent

Exclusion Criteria:

* Recent use of systemic hormone therapy or hormonal contraceptives
* Recent use of any prescribed, over-the-counter or herbal therapies that are taken specifically for hot flashes
* Recent use of selective estrogen receptor modulators (SERMS) or aromatase inhibitors
* Recent use of psychotropic medications, including SSRIs (selective serotonin reuptake inhibitors), serotonin-norepinephrine reuptake inhibitors (SNRIs), MAOIs (monoamine oxidase inhibitors), and other antidepressants and anxiolytics.
* Known hypersensitivity or contraindications (reasons not to take) to venlafaxine, estrogen, or progestins
* Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period
* Recent drug or alcohol abuse
* Lifetime diagnosis of psychosis or bipolar disorder
* Suicide attempt in the past 3 years or any current suicidal ideation
* Current major depression (assessed during screening)
* Pregnancy, intending pregnancy, or breast feeding
* History of:

  * Pre-breast cancer or high-risk breast cancer condition
  * Abnormal bleeding suggestive of endometrial pre-cancer or endometrial hyperplasia
  * Asthma, diabetes mellitus, epilepsy, and migraine disorders that are not stable or under medical management
* Abnormal screening blood tests
* Current participation in another drug trial or intervention study
* Inability or unwillingness to complete the study procedures