cyrilzakka/clinical-trials huggingface dataset:
Effect of Oral Feeding in Infants With Pierre Robin Syndrome

This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

Pierre Robin Syndrome (PRS) can cause dysphagia. In China, persistent nasogastric tube feeding (PNG) is the mainstream choice as nutrition support in the dysphagic infants with PRS. However, PNG is associated with various complications, necessitating the exploration for a safer and more effective nutritional support approach. Therefore, this study aims to observe the clinical effect of intermittent oro-esophageal tube feeding (IOE) compared to PNG in the dysphagic infants with PRS who received systemic therapy.

This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with IOE) and the PNG group (with PNG), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

Eligibility Criteria:
Inclusion Criteria:

* meeting the diagnostic criteria for Pierre Robin sequence based on CT and X-ray examinations, combined with clinical manifestations and physical signs.
* with spontaneous vaginal birth, aged 1 to 12 months.
* with dysphagia screened by the water drinking test and further confirmed by the assessment of Dysphagia Disorders Survey (DDS), Dysphagia Severity Scale (DSS), or Schedule for Oral Motor Assessment (SOMA)
* before the treatment, the tube feeding was required and feasible after evaluation.
* stable vital signs.
* with nasogastric tubes placed before the treatment.
* sufficient human milk could be provided by the mothers of the patients (with the help of a manual suction device).

Exclusion Criteria:

* abnormalities in brain development or other neurological lesions revealed by CT or MRI scans.
* dysphagia caused by other diseases.
* other congenital malformations, such as Down syndrome, cleft lip, and palate, etc.
* severe systemic disease (such as severe infection, severe hepatic and renal dysfunction).
* participants who need to receive other therapy which would potentially affect the result of this study
Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects

The purpose of this study was to investigate Safety, tolerability and pharmacokinetics in Chinese healthy subjects.

This was a single center, Phase 1, open-label SAD and MAD study designed to assess safety, tolerability and PK of orally administered THR-1442 tablets in Chinese healthy adults.

Subjects were enrolled to receive 20mg THR-1442 tablet in Single dose group (20mg\*1 day) and multiple dose group(20mg\*7days).

Blood samples for THR-1442 plasma concentrations were collected 0h till to 48hours.

Eligibility Criteria:
Inclusion Criteria:

1. Be able to understand and be willing to sign informed consent and voluntarily participate in the study;
2. Chinese women or men aged 18-45 (including 18 and 45) at the time of screening;
3. Men or women who agree to effective contraception from the screening period until 30 days after the last dose in the trial; Agree to take at least one effective contraceptive measure;
4. During screening and baseline, male weight ≥ 50.0kg, female weight ≥ 45.0kg, body mass index (BMI) in the range of 19 \~ 25.0kg/m2 (including 19 and 25.0kg/m2), \[BMI = weight (kg) / height 2 (M2)\];

Exclusion Criteria:

1. According to the judgment of the site investigators, including clinical significant medical history in CNS, CV system, respiratory system, blood / hematopoietic system, gastrointestinal system, liver / kidney system，etc;
2. Subjects with specific allergic history or allergic constitution such as drugs, food and pollen, or allergic to SGLT2 inhibitors or similar drugs;
3. Alcoholics (drinking 14 units per week, each unit equivalent to 360mL beer or 150mL wine or 45mL alcohol of 40% alcohol), drug or drug dependence subjects; Smokers (smoking \> 5 cigarettes per day or the same amount of other tobacco products);
4. Subjects with a history of bladder dysfunction, such as urinary incontinence, frequent urination or nocturia;
5. Blood donation within 3 months before screening, including component blood or massive blood loss (≥ 200ml), receiving blood transfusion or using blood products;
6. Subjects who used prescription drugs, traditional Chinese medicine, over-the-counter drugs (OTC), vitamins, dietary supplements or supplements (e.g. ginseng) within 4 weeks before the first administration;
7. From 7 days before the first dose to the whole study period, subjects who are unwilling or unable to guarantee to forbid by the following: no smoking, no alcohol, no caffeine containing products (including chocolate, tea, coffee, cola, etc.) and avoid strenuous exercise;
8. Those who are unwilling or unable to guarantee to forbid pitaya, grapefruit, mango, carambola, fruit juice and spicy food containing the above fruits from 7 days before taking the medicine and the whole test period;
9. The subject was unable to swallow the study drug or had gastrointestinal diseases leading to absorption disorders;
10. Subjects who had participated in any drug or medical device clinical trial within 3 months before screening;
Ketamine and Midazolam Infusions for CRPS: Feasibility Study

This study will assess the feasibility of administering ketamine plus midazolam or midazolam alone, when infused over 5 days in an outpatient setting, to adults with complex regional pain syndrome (CRPS).

Subanesthetic ketamine infusions are a potentially impactful treatment for chronic refractory pain, but the acute psychoactive effects of ketamine complicate successful masking in randomized trials. Multi-day ketamine infusions have produced long-lasting, but not permanent, remission of symptoms in complex regional pain syndrome (CRPS), a chronic and often debilitating neuropathic pain condition that can affect one or more limbs. In this feasibility study, 4 adults with CRPS will be randomized to receive either ketamine and midazolam or midazolam-only, infused over 5 days in an outpatient setting. The objectives of this feasibility study are:

1. Assess whether the recruitment and retention rate observed in this feasibility study can support a larger clinical trial.
2. Evaluate whether participants can adhere to study procedures.
3. Determine whether midazolam, when given alone as an intravenous (IV) infusion, can be used as an active placebo that is well-tolerated, practical, and believable compared to a ketamine plus midazolam infusion.
4. Gather preliminary data on clinically-relevant outcomes for CRPS.

Eligibility Criteria:
* Age 18 to 65 years
* Meets the International Association for the Study of Pain (IASP) diagnostic criteria for complex regional pain syndrome (CRPS)
* Primary complaint of CRPS-attributable pain for ≥3 months
* Average pain intensity of ≥3/10 over the last month
* Can read and comprehend English-language questionnaires
* Can receive text messages by phone
* Can identify a responsible adult who can provide transportation to and from infusion site for 5 consecutive days (Mon-Fri)
Pathogens Responsible for Respiratory Infections Associated With Drowning in Seawater

Little data is currently available on the type of pathogen responsible for respiratory infections following drowning. Many environmental germs present in seawater are described as difficult to culture on standard media but are potentially pathogenic. Even using specific culture media nearly 90% of the bacteria present in the water remain non-cultivable. The use of 16S and 18S rDNA amplification followed by high throughput sequencing on respiratory samples could allow us to objectify these bacteria potentially involved in the physiopathological process secondary to drowning and thus improve their overall management.

Carrying out a bronchoalveolar lavage (BAL) within 24 hours after admission to intensive care with analysis on standard and specific culture media of environmental germs, carrying out antibiograms, DNA extraction, amplification by universal 16 and 18S rDNA primers followed by high flow sequencing and phylogenetic analysis of pathogens found. Comparison of these results with the same analyses performed on seawater samples taken near the drowning site and during a new AML at 72h for patients still intubated and showing signs of pneumonia in order to determine if the pathogens detected at the entrance persist and are present in the environment.

AML at the patient's entrance, on day 3 and environmental sampling in the drowning environment within 24 hours. Standard and specific bacteriological analyses with molecular biology techniques (amplification 16 and 18S rDNA) carried out at Pr RUIMY's laboratory (Nice University Hospital) sequencing on INRA's Toulouse genomics platform. Phylogenetic data capture and analysis at IRCAN (Bioinformatics, Croce Olivier). Patient follow-up until resuscitation discharge.


Eligibility Criteria:
Inclusion Criteria:

* adult patient
* hospitalized in intensive care for severe drowning in sea water (Spilzman stage 5 or 6) (4)
* intubated within 24 hours of admission or before admission to intensive care
* affiliated to social security

Exclusion Criteria:

* patients under guardianship, trusteeship or detention
Chemo- and Radiotherapy in Epithelial Vulvar Cancer

This retrospective, multicenter study is designed to collect tumor characteristics as well as treatment data from patients diagnosed with primary or recurrent squamous cell cancer of the vulva with emphasis on indication and application of radio- and chemotherapy. Application of chemotherapy in primary treatment of vulvar cancer is rare; the study collective is therefore extended to relapsed disease.

All patients with primary squamous cell cancer of the vulva \> stage Ia who were diagnosed and received treatment between 1998 and 2008 at the participating centres will be included in the study. Furthermore patients with recurrent disease diagnosed and treated at the participating centres during the same time period can be included given that they not only underwent surgical excision for treatment.

For centers with restricted resources for data entry an alternative study collective was defined:

All Patients with primary or relapsed squamous cell vulvar cancer receiving radio- and/or chemotherapy for treatment at the participating centres between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radio/chemotherapy for other reasons.

The participating centers themselves have to decide which study collective they are documenting, dependent on their available resources.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary squamous cell vulvar cancer except stage Ia disease regardless of the received treatment
2. Patients with recurrent squamous cell vulvar cancer, if the relapse was not only treated with a surgical excision.
3. Or alternatively, dependent on the decision of the participating center:

   -Patients with primary or relapsed squamous cell vulvar cancer receiving radio- and/or chemotherapy for treatment regardless of nodal involvement.
4. Patients who were diagnosed with and treated for primary or relapsed vulvar cancer between 1998 and 2008
5. Women aged ≥ 18 years

Exclusion Criteria:

1. Patients with benign or precursor lesions (VIN - vulvar intraepithelial neoplasia) of the vulva
2. Patients with non-squamous neoplasia of the vulva (e.g. melanoma)
3. Patients with verrucous vulvar cancer
4. Patients with relapsed squamous cell vulvar cancer only receiving surgical excision for treatment.
5. Patients with secondary cancers if those interfered with the treatment of vulvar disease
Weight-bearing Training in Stroke Patients.

1. Are there differences in weight-bearing (WB) and WB symmetry immediately following STS and stepping training with or without using external feedback in ambulatory patients with stroke?

1. Are there differences in mobility immediately following STS and stepping training with or without using external feedback in ambulatory patients with stroke?

Subjects are patients with stroke, the age of over 40 years to 74 years, both males and females who are able to walk independently at least 10 meters. Most of them will be recruited from a tertiary rehabilitation center and communities. Subjects have to participate in STS and stepping training with and without using the external feedback for 1 time/condition with a wash-out period for 2 weeks (crossover design). The outcomes will be measured in terms of WB ability during STS and stepping, walking speed, and balance ability.

The primary outcomes were WB ability on the affected limb and WB symmetry. Secondary outcomes were walking speed and balance ability.

Eligibility Criteria:
Inclusion Criteria:

* Independent ambulatory patients with chronic stroke (post-stroke time more than 6 months)
* Age at least 40 years to 74 years
* Body mass index (BMI) between 18.5- 29.9 kg/m\^2
* Ability of independent walking over at least 10 meters with or without a walking device
* Ability to rise from a chair with or without using their arms
* Ability to follow a command used in the study

Exclusion Criteria:

any conditions that may affect ambulatory ability or ability to participate in the study, such as

* Auditory or visual deficits that are unable to be corrected by a hearing aid, glasses or contact lens
* Musculoskeletal pain with a pain scale more than 5 out of 10 on a visual analog scale (VAS)
* Deformity in the limbs or spine that affect ambulatory ability
* Modified Ashworth Scale (MAS) more 2 score
* Unstable cardiovascular, orthopedics, musculoskeletal, or neurological disease other than stroke.
Assessment of a Tool for Decision Making in Case of Worsening Condition of Cancer Patients

Observational two year study to evaluate the utility of a decision-support sheet on how to proceed in case of aggravation of a patient's condition with advanced disease.

Prospective and multicenter study conducted in the Rhône-Alpes-Auvergne area. All patients suffering from lung cancer admitted to a pulmonology unit in 2014 will be included. This document will be used if a decision to withhold life-sustaining treatment is decided. Investigators will assess the relationship between the planned intensity of care and those established when the patient develops an organ failure. Patient characteristics and factors associated with proposed levels and types of care will be analyzed. Patient and family opinions will be obtained after 3 months. The number of subjects is 468.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with lung cancer, hospitalized in pulmonology unit in one of the participating centers.
* Patient who requires a decision to withhold life-sustaining treatment
* One patient can be included at each hospitalization.

Exclusion Criteria:

* Minor patient
* Refusal of participation of the patient in the study
A Fourteen-Week Placebo-Controlled Dose-Response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE)

To demonstrate efficacy and dose-response of NS 2330 versus placebo in patients with early Parkinson's Disease in 14 weeks of treatment, and to investigate the safety and tolerability of NS 2330 in these patients.


Eligibility Criteria:
Parkinson's disease for \<5 years, non-demented, no or \<6 months of levodopa and none during trial. Off levodopa, DA agonists, and psychotropics for 30 days before screening. Amantadine, anticholinergics allowed if at stable dosage. Hoehn \& Yahr stage I-III. Depression allowed, but no other chronic disease that is unstable or might interfere with ability to participate.
Educational Tools to Improve Beliefs About Pain and Reduce Pain-related Disability

This trial aims at comparing the effectiveness of different didactic tools developed for patients with chronic pain to correct misbeliefs and improve disability in patients with chronic low back pain

This trial aims at comparing the effectiveness of different didactic tools (an educational website vs a booklet) developed for patients with chronic pain to correct misbeliefs and improve disability in patients with chronic low back pain.

Participants of the 2 experimental groups will be invited to use the tool they receive during a one-month period.

Eligibility Criteria:
Inclusion Criteria:

* individuals with non-specific persistent low back pain (pain \> 6 months) who had their pain assessed by their general practitioner or a specialist within the last 3 months

Exclusion Criteria:

* specific low back pain,
* educational treatment (back school, cognitive-behavioral, pain neurosciences education) in progress or planned during the study period
* previous consultation of the didactic tools investigated in the present study
* nerve root compromise,
* recent spinal surgery (\<3 months)
* not fluent in French
* no regular access to a computer and the internet
* present follow-up by a psychiatrist
Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France

the purpose of this study is to describe the way Faslodex is used in France, in patients suffering from initial breast cancer, that is to evaluate Faslodex treatment duration and to determine patients profile


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007
To Determine the Efficacy of a Laser Device for the Treatment of Hidradenitis Suppurativa

A research study to determine the efficacy of a 1320 nm laser device for the treatment of hidradenitis suppurativa.

Hidradenitis Suppurativa is a chronic, scarring disease. The treatments available for this condition are not very effective and work only for some patients.

Recently, a 1320nm laser device has been approved by the FDA for the treatment of acne and facial rejuvenation. Given the positive results seen with the use of this laser in the treatment of acne it is reasonable to hypothesize that a similar effect may be seen with the treatment of Hidradenitis suppurativa.

The specific aim of the study is to determine the efficacy of this device for the treatment of hidradenitis suppurativa as it relates to the patient's established treatment.

The investigators are trying to determine the efficacy of a laser for the treatment of hidradenitis suppurativa.

Patients will:

* be examined and interviewed
* have photographs taken of the treatment site
* have a 4mm punch biopsy performed
* have wound culture swabs performed

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years
* General good health and willingness to participate and ability to comply with the study protocol
* Biopsy proven hidradenitis suppurativa

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Hx of collagen vascular or photosensitive disorders
* Inability to follow-up with treatments
The Effects of Losartan on Social Reward

The aim of the study is to investigate the effect of losartan (50mg, single dose) on social reward

In a double-blind, between-subject, placebo-controlled design the effects of a single dose of losartan (50mg) on social reward in healthy participants will be examined. 90 minutes after subjects administrate 50mg losartan or placebo, participants will undergo a social incentive delay task. Neural activity will be assessed by the acquisition of functional magnetic resonance imaging (fMRI) data.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness
* hypertension
The Effect of Losartan on the Recoverability of Renal Function in Anuric and Oliguric Patients With Unilateral Obstructed Kidney

Previous experimental studies concluded that angiotensin receptor blockers can ameliorate the harmful inflammatory and histological changes after relief of obstruction. Nevertheless, these witnessed effects have not been yet translated into the clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* anuric and oliguric patients
* calculuar ureteral obstruction

Exclusion Criteria:

* anomalous kidney
* bilateral obstructed kidney
* history of recent use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors
* ASA score of \>3
Study of ABT-869 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be histologically or cytologically diagnosed with advanced or metastatic NSCLC
* Subjects must have at least one lesion measurable by CT scan as defined by RECIST
* The measurable lesion may have not received radiation therapy
* Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
* Subject has received at least one prior line of systemic treatment but no more than two treatment regimen(s) for advanced or metastatic NSCLC. In addition, the subject may have received systemic neo-adjuvant or adjuvant chemotherapy for NSCLC
* Adequate organ function

Exclusion Criteria:

* Subject has received targeted VEGF/PDGF TKI (tyrosine kinase inhibitor) therapy. Prior Avastin is allowed.
* Subject has untreated brain or meningeal metastases.
* History of greater than 10% weight loss
* Subject has clinically relevant hemoptysis
* The subject has proteinuria CTC Grade \> 1
* The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure \> 100 mmHg or systolic blood pressure \> 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention.
* The subject has a documented left ventricular ejection fraction \< 50%
Virtual Reality in Labor and Delivery for Reduction in Pain

The purpose of this study is to identify whether use of virtual reality devices can improve the pain management of women in labor and delivery. The investigators will perform a randomized controlled trial of patients in labor at Cedars-Sinai Medical Center.

The purpose of this study is to identify whether use of virtual reality devices can improve the pain management of women in labor and delivery. The investigators hypothesize that use of virtual reality devices will result in a reduction in pain medication use, in epidural use, and prolong the duration of time prior to the patient receiving an epidural.

The study will be conducted as two parallel randomized controlled trials: one for latent labor patients and one for patients in active labor (defined by whether they are \< 6 cm or \> 6 cm). Within each phase of labor, there will be 20 in the Virtual Reality arm and 20 in the Control arm for a total of 80 patients.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. \>18 years old
3. Pregnant with term gestation
4. Nullipara
5. Pain due to contractions rated from 4-7
6. Contractions at least every 5 minutes x 30 minutes preceding
7. Pain scores obtained at least every 60 minutes

Exclusion Criteria:

1. Parous
2. Use of intravenous medications for pain relief prior to the intervention
3. Use of an epidural
4. Preterm gestation
5. Pain not due to contractions
6. Pain score of 3 or below or 8 or above