cyrilzakka/clinical-trials huggingface dataset:
Study of Metabolic Content of Urine

The purpose of this research study is to test the different components in urine and see if they can be matched to food, exercise and sleep that participants report. The researchers are trying to find out if urine would allow them to predict medical problems as they are happening. Participants are healthy volunteers who are willing to give urine samples on a daily basis, and can expect to be in the study for 28 days.

The purpose of this research study is to analyze urine samples using Mass Spectrometry to identify metabolites that have the potential to be used for medical diagnosis. This data, along with data from wearable devices, will be combined and analyzed to correlate what an individual does on a daily basis with how their body metabolizes their choices. This type of data may provide insights into the origins and progression of diseases in a short time span.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years or older
* Be able to provide informed consent
* Stated willingness to comply with all study procedures and have availability for the duration of the study

Exclusion Criteria:

* Presence of a condition(s) or diagnosis, either physical or psychological, that limits the ability to urinate in the collection apparatus
* Individuals who do not consistently get at least 6 hours of sleep per night
* Individuals who have a sleep disorder diagnosis.
* Individuals who live in the state of New York
Early Rehab With VR for First-time Acute Stroke

The goal of this clinical trial is to confirm the efficacy and feasibility of early rehabilitation combined with virtual reality training in patients following first-time acute stroke. The main questions it aims to answer are:

* The impact of virtual reality training on muscle strength;
* The impact of virtual reality training on functional recovery;
* The impact of virtual reality training on mood state.

Researchers will compare the experimental group, which received early rehabilitation combined with VR training, and the comparison group, which received only early rehabilitation, to see if VR training has clinical benefits when provided alongside early rehabilitation during hospitalization.

Early rehabilitation has been shown to enhance outcomes for patients with first-time acute stroke. However, whether the addition of virtual reality (VR) training could further improve muscle strength, functional recovery, and mood state for these patients is unknown. Therefore, this study aimed to investigate the effectiveness of early rehabilitation combined with VR training in patients following first-time acute stroke. Patients with acute ischemic stroke will be selected and randomly assigned with a 1:1 randomization ratio to either the experimental group or the comparison group. Both groups received early rehabilitation, and the experimental group received extra VR training starting 24 hours to 3 days poststroke during the stay in the hospital. Muscle strength, functional status, and mood state will be collected before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* first-time acute infarction (ischemic stroke);
* admission to the hospital within three days of stroke onset;
* able to communicate with verbal or nonverbal methods and understand Mandarin;
* had a disability that ranged from minimal to moderately severe disability and evaluated as 1-4 scores by the modified Rankin Scale (mRS);
* agree to be randomized.

Exclusion Criteria:

* diagnosis of global aphasia, transient ischemic attack, visual or auditory impairment;
* mRS over 5 (severe disability: requires constant nursing care and attention, bedridden, incontinent);
* a history of cancer, end-stage renal disease with dialysis, dementia, mental health disorders (particularly major depression), based on both of medical records and assessments from the neurologist;
* being unable to participate due to other comorbid neurological and musculoskeletal conditions that produce moderate-to-severe physical disability;
* prolonged stay in hospital for over three weeks due to other medical diseases (e.g., myocardial infarction, septic shock, cancer) after admission or length of stay in hospital less than one week due to a decline to treatment and transferred to another hospital for further confirmation of diagnosis and other complementary or alternative therapies.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM (Nangibotide) in Patients With Septic Shock

This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of nangibotide versus placebo in adult patients with septic shock.

This was a randomised, double-blind, two-stage, placebo-controlled study. It was composed of 2 stages with a similar treatment regimen in which 0.3, 1.0 or 3.0 mg/kg/h of nangibotide was tested versus placebo.

Stage 1 was performed to investigate ascending doses of nangibotide or placebo in a sequential design in cohorts of 4 patients (3:1 randomisation). After completion of a cohort (for up to 5 days of infusion), safety and available PK data were blindly reviewed by an independent data safety monitoring board (DSMB) before progressing to the next cohort. After completion of stage 1 DSMB evaluation, the study progressed to stage 2.

Stage 2 investigated 3 doses of nangibotide in a randomised, balanced, parallel-group design involving up to 3 doses of nangibotide and a placebo arm. Only dose arms of nangibotide considered to be safe and well tolerated during Stage 1 were to be administered in Stage 2.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent (proxy/legal representative) according to local regulations
* Age 18 to 80 years
* Documented or suspected infection: lung, abdominal or elderly UTI (≥65 years)
* Organ dysfunction defined as acute change in SOFA score ≥ 2 points
* Refractory hypotension requiring vasopressors to maintain MAP ≥65mm Hg despite adequate volume resuscitation of at least 20 ml/kg within 6 hours
* Hyperlactatemia (blood lactate \>2 mmol/L or 18 mg/dL). This criterion must be met at least once for the purpose of diagnosis within the 24 hours before study drug administration

Exclusion Criteria: -

* Previous episode of septic shock (vasopressor administration) within current hospital stay
* Underlying concurrent immunodepression (specified in appendix 2)
* Solid organ transplant requiring immunosuppressive therapy
* Known pregnancy (positive serum pregnancy test)
* Prolonged QT syndrome (QTc ≥ 440 ms)
* Shock of any other cause, e.g. hypotension related to gastrointestinal bleeding
* Ongoing documented or suspected endocarditis, history of prosthetic heart valves
* End-stage neurological disease
* End-stage cirrhosis (Child Pugh Class C)
* Acute Physiology And Chronic Health Evaluation (APACHE) II score ≥ 34
* End stage chronic renal disease requiring chronic dialysis
* Home oxygen therapy on a regular basis for \> 6 h/day
* Severe obesity (BMI ≥ 40)
* Recent CPR (within current hospital stay)
* Moribund patients
* Decision to limit full care taken before obtaining informed consent
* Participation in another interventional study in the 3 months prior to randomisation
Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose

Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
* Subject is 18 to 75 years of age, inclusive.
* Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version \[SCID-CT\]).
* Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304):

  * Elevated, expansive mood
  * Inflated self-esteem or grandiosity
  * More talkative than usual or pressure to keep talking
  * Flight of ideas or subjective experience that thoughts are racing
  * Increase in energy or goal-directed activity (either socially, at work or school, or sexually)
  * Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
  * Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia)

Exclusion Criteria:

* Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening.
* Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.
* Subject has attempted suicide within the past 3 months.
* Subject has a lifetime history of any bipolar I manic or mixed manic episode.
* Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.
Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor

The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.

Induction of labor in term pregnancy may be challenging, especially in patients with unfavorable cervical conditions. Numerous trails have presented evidence of the efficacy of the trans cervical Foley catheter for pre-induction cervical ripening.The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy
* Medical indication for labor induction by transcervical Foley catheter

Exclusion Criteria:

* Preterm pregnancy
* Contraindication for induction of labor by transcervical Foley catheter or by IV Oxytocin:

  * Uterine scar
  * Multiple pregnancy
  * PROM
  * Grand-multiparity
  * Placenta previa or marginal placenta
  * Spontaneous uterine contractions (more than 3 in 10 minutes)
  * Vaginal bleeding
  * Nonreassuring fetal heart rate
Inclusion Appeal Videos and Intent to Register for Pediatric Clinical Trials

An informational video about joining a Research Notification Registry is being compared with a version of the video tailored to African/ African American parents, reminding them about the importance of their being included in clinical trials. African/African American parents and caregivers of children under 13 years of age are targeted.

Improving diversity in research projects and national data repositories is critical to providing safe and effective care to marginalized groups. Unfortunately, certain groups such as African Americans are inadequately represented in much of the available data and in current clinical trials. Recently, investigators have begun employing new messaging approaches to increase diversity in clinical trial enrollment. These messages are typically designed to inform, with no appeal for specific groups to act, and no tailoring that takes into account specific groups. Very little is known about the potential impact of inclusion appeals--direct appeals to historically marginalized groups calling on their need to be included in research studies. Applying the science of appeals to recruitment messages may improve the effectiveness of educational videos and lead to greater participation in research. This pilot study proposes to empirically study whether an inclusion appeal increases decisions to enroll children in studies.

Eligibility Criteria:
Inclusion:

1. English speaking
2. Self-identified African or African American
3. Not already enrolled in any research participant registry, no history of clinical trial participation
4. At least one child in their care age newborn to 13

Exclusion:

1. Parents with children over the age of 13
2. Non-English speakers
3. Previously enrolled in Children's Hospital of Philadelphia registry, history of clinical trial participation
Immunogenicity and Safety of V70P5 Revaccination Subjects

This study will evaluate the safety and immunogenicity of children previously primed in the V70P5 study when revaccinated with adjuvanted or unadjuvanted seasonal influenza vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female children that have previously participated in the V70P5 study in Finland.

Exclusion Criteria:

* Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives.
Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum

CLONEMESI is an academic, independent, randomized placebo-controlled trial to assess the effect of transdermal (TD) clonidine in improving the symptoms of severe Hyperemesis Gravidarum(HG) affecting women in their 6th-12th week of pregnancy. The study has a crossover design.

Setting. The trial is performed at a single hospital setting after admission of patients.

Ethics. The study has been approved by our local Ethics Committee and women are requested to sign an informed consent. No pharmaceutical company is involved in any phases of the trial including protocol design, study conduction, coordination and monitoring, data handling and analysis.

Randomization. The patients are allocated to a random list to receive first placebo and then TD clonidine or the other way round.

Blinding. Neither the patients nor their attending caregivers know the order of administration . The outcome assessors are blinded as well.

Treatment.The patients are randomly treated with and without TD clonidine for 2 consecutive periods of 5 days , other antiemetic drugs (promethazine, metoclopramide, ondansetron) and anti- reflux drugs (ranitidine, omeprazole) being administered on a scheduled or as-needed basis. All patients receive intravenous hydration and supplementation with thiamine.

Assessment. Physical condition of patients are assessed daily: blood pressure (lying and standing), body weight, morning ketonuria. Two different clinical self administered scores as PUQE (Pregnancy Unique Quantification of Emesis) and VAS (Visual Analogue Scale) are employed to check daily the intensity of symptoms and the sense of wellbeing. The consumption of antiemetic and anti-reflux drugs administered in the two periods is monitored .

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 6-12 weeks and a major grade of HG clinical severity defined as follows:
* a PUQE score index ≥ 13 associated to one or more of the following conditions:
* weight loss \> 5% of pregravidic weight,
* electrolyte disturbances,
* dehydration,
* duration of symptoms \> 10 days ,
* inadequate food and drink intake

Exclusion Criteria:

* Language barrier.
A Phase 1b Study to Investigate Safety and Tolerability of ARGX-119 in Adult Participants with DOK7-Congenital Myasthenic Syndromes (CMS)

The purpose of this study is to assess the safety and tolerability of ARGX-119 in adult participants with DOK7- Congenital Myasthenic Syndromes. The study will also assess how ARGX-119 is processed by the body (pharmacokinetics), how the immune system reacts to it (immunogenicity), and how it may improve the way patients feel and function.

After the screening period, eligible participants will be randomized in a 4:1 ratio to receive intravenous infusions of ARGX-119 or placebo during the treatment period. Participants will then enter the follow-up period. The full duration of the study is approximately 11 months.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Has genetically confirmed congenital myasthenic syndromes due to mutation of downstream of kinase 7 (DOK7-CMS).
* Participants taking oral beta agonists (eg, albuterol, salbutamol, ephedrine) must have been receiving the medication for more than 3 months and agree to remain on a same stable dosing regimen of the same medication until the end of the study.

Exclusion Criteria:

* Diagnosis of CMS due to mutation of any gene other than DOK7.
* Known medical condition that would interfere with an accurate assessment of CMS, confound the results of the study, or put the patient at undue risk, as assessed by the investigator.
* History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for more than 5 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer.
* Different study drug received in another clinical study within 12 weeks or 5 half-lives before screening.
* Current participation in another interventional clinical study or prior participation in any gene therapy or cell therapy study.
* Pregnant or lactating state or intention to become pregnant during the study.

The complete list of exclusion criteria can be found in the protocol.
Factor VIIa in Acute Intracerebral Haemorrhage

This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute intracerebral haemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Spontaneous ICH

Exclusion Criteria:

* Time of ICH onset \> 3 hours
* Patients with secondary ICH
* Pre-existing disability
* Hemophilia
TIBOLA : Multicenter Descriptive Study in Eastern France

TIBOLA (TIck-BOrne LymphAdenopathy) is a tick-borne disease. The pathogen is most often rickettsia (R. slovaca or R. raoultii), but other strict intracellular bacteria have been described (Francisella tularensis, Coxiella burnetii, Bartonella hensenlae).

Transmitted by ticks (Dermacentor), it is characterized by an inoculation eschar at the tick bite site, accompanied by painful loco-regional lymphadenopathy. It is most often a benign pathology, which can nevertheless leave sequellar alopecia or persistent asthenia.

In spring 2021, an impression of increased cases was reported by clinicians in Eastern France. The study aims to clarify the clinical-biological presentation and the evolution of the number of cases of TIBOLA in this region between 2016 and 2021.

At the same time, entomologists have noted an upsurge in this tick in certain biotopes in recent years.


Eligibility Criteria:
Inclusion Criteria:

* Person, minor or major,
* having been diagnosed with TIBOLA
* between January 1, 2016 and December 31, 2021
* at the University Hospital of Nancy or Strasbourg in the departments of infectious and tropical diseases, dermatology, microbiology and pediatrics.
Study Designed to Optimize the Treatment of Primary Pneumothorax

Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial.The Aim of this study is to optimize the treatment, estimate the actual incidence, and identify possible risk factors including genetic predispositions.

* Background Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial. Typically, the first incidence is treated conservatively with simple chest tube drainage and only if the disease reoccurs is surgery considered. However, conventional treatment may be associated with increased morbidity, prolonged hospitalization and many young adults are concerned about the high recurrence of this disease. The latter has been reported in as many as 25-35% of patients. Because spontaneous pneumothorax in young adults usually is associated with apical blebs, the investigators hypothesized that primary surgery (Video-Assisted Thoracoscopic Surgery = VATS) with resection of such blebs at the time of the first episode of pneumothorax might be an effective first line treatment associated with lower morbidity and shorter hospital stays, and a definite decline in recurrence rate.
* Method From July 2009 the investigators conducted a nationwide study , where 300 consecutive patients admitted to a Danish hospital with primary spontaneous pneumothorax undergo a high resolution CT of the thorax. Based upon the CT the patients are randomised to conventional conservative treatment (chest tube drainage) or primary VATS with bleb resection and mechanical pleurodesis.

Participants are followed for ten years. The primary endpoint is ipsilateral recurrence of pneumothorax. Secondary endpoints are length of hospitalization, duration of chest tube drainage and miscellaneous complications.

Simultaneously, a research biobank containing blood samples and pulmonary tissue is created for future studies of biomarkers and possible genetic causes.

Finally, the investigators are conducting a national epidemiological study, where the incidence in the Danish population is investigated.

\*Perspective This study contributes new knowledge on incidence, genetics and best treatment of primary spontaneous pneumothorax in young adults which will have an impact on the future strategy of both understanding and treatment of this disease on a global level.

Eligibility Criteria:
Inclusion Criteria:

* First incidence of primary spontaneous pneumothorax.
* Age between 18 and 40.
* No known preexisting pulmonary disease.
* Patient must accept randomization.
* Able to read and understand information regarding the study.
* The condition must require treatment with a chest-tube.

Exclusion Criteria:

* Age above 40.
* Previously pulmonary og cardiac surgery.
* Pregnant or breastfeeding.
* Patients who do not tolerate anesthetics.
Parkinson's Disease, Diagnostic Observations (PADDO)

Background:

Parkinson's Disease and the Atypical Parkinsonian Disorder (like Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia) are disease entities with partly common symptomatology. Especially very early in the course of disease, the differentiation between both disease entities can be challenging, even for specialists in the field of movement disorder. However, the establishment of a correct diagnosis is very important for adequate patientcounseling, treatment and the correct inclusion of patients in research trials. Ancillary diagnostic investigations are looked upon to aid in this diagnostic dilemma.

Objective:

To investigate the value of ancillary diagnostic investigations, more specific MRI, analysis of cerebrospinal fluids and a second opinion in a specialized movement disorder centre, to differentiate Parkinson's disease and the Atypical Parkisonisonian disorder.


Eligibility Criteria:
Inclusion Criteria:

* Hypokinetic rigid syndrome
* Disease duration of maximum 36 months

Exclusion Criteria:

* Probable diagnosis of PD without any red flags
* Probable diagnosis MSA
* Probable diagnosis PSP
* Diagnosis CBD
* Diagnosis DLB
* Probable diagnosis Vascular Parkinsonism
* Other neurodegenerative disease than parkinsonism
* A prior history of brain surgery
* Instable comorbidity