cyrilzakka/clinical-trials huggingface dataset:
Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily

It is a phase IV clinical trial: longitudinal, prospective, evaluator-blind, randomized into 2 groups of patients with chronic obstructive pulmonary disease (COPD). The intervention group was based on the administration of roflumilast 500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks (phasing). In the control group assigned to undertake the treatment according to the standard dosage (roflumilast 500μg od).

The patient monitoring will be done by one of the sub-investigators fully independent team that started the medication keeping the pattern masking by single blind, and since it aims to assess the frequency of adverse events (AEs) in both groups were collected systematically different AEs and their characteristics at 15 days (V1), and from that moment a month (V2) and 2 months (V3). Likewise, other data collected (functional demographic, comorbidities, home treatment, anxiety and depression and quality of life).

The purpose of this study is to assess whether the administration of roflumilast by a gradual pattern varies the incidence of discontinuations due to adverse events when compared with the usual dosage.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD in severe degree GOLD criteria, assessed by post-bronchodilator spirometry (FEV1 \<50%, FEV1/Forced vital capacity (FVC) \<70% of theory).
* Age over 18 years.
* Productive cough recurrently most days for at least three months a year and at least 2 consecutive years.
* History from smoking prior\> 15 to 20 packs / year.
* An exacerbation in the previous year.
* Stability clinic in the last 30 days.

Exclusion Criteria:

* Pregnancy / breastfeeding.
* Acute infections.
* Patients with severe mental disorder or uncontrolled, in the opinion of the investigator, would make the patient has a higher risk due to their participation in the study, could be a confounding factor in the study's results or is likely to prevent that the patient meets the requirements of the study or to complete the study.
* Patients cachectic or the risk of cachexia.
* HIV infection.
* Severe immune Infections (systemic lupus erythematosus, multiple sclerosis, etc.).
* Gastroesophageal reflux symptoms and diagnosis established.
* Hiatal hernia.
* Peptic ulcer disease.
* Inflammatory bowel pathology.
* Neoplastic pathology: current diagnosis of cancer other than basal cell or squamous cell carcinoma of the skin.
* Moderate to severe hepatic impairment (Child-Pugh BC).
* Inability to understand / perform the techniques.
* Home treatment with theophylline, methotrexate, azathioprine, infliximab, etanercept, inducers of cytochrome P450 (eg, rifampicin, phenobarbital, carbamazepine, phenytoin),cytochrome P450 3A4 (CYP3A4) inhibitors (erythromycin and ketoconazole), oral contraceptives (gestodene and ethinyl estradiol), making prolonged oral corticosteroids, or a drug that contains fluvoxamine, enoxacin and cimetidine.
Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran

Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia out-patients


Eligibility Criteria:
Inclusion Criteria:

* patient with FMS according to the 1990 ACR criteria
* patient willing to withdraw from CNS-active therapies commonly used for FMS, including anti-depressants, anti-convulsivants, opiates
* patient willing to discontinue treatment with tender and trigger point injections, joint injections and anesthetics

Exclusion Criteria:

* severe psychiatric illness
* current Major Depressive Episode (MDE)
* significant risk of suicide
* history of substance abuse
* epilepsy
* myocardial infarction in the past 24 months
* active cardiac disease
* congestive heart failure
* prosthetic heart valve
* haemodynamically significant valvular heart disease
* known cardiac rhythm anomalies or conduction abnormalities
* unstable and uncontrolled arterial hypertension or supine arterial blood pressure over 160/90 mmHg
* pulmonary dysfunction
* active liver disease
* renal impairment
* documented autoimmune disease
* current systemic infection
* active cancer, except basal cell carcinoma or current cancer therapy
* severe sleep apnoea
* active peptic ulcer or inflammatory bowel disease (except IBS)
* unstable endocrine disease
* pregnancy or breastfeeding
* concomitant use of non selective MAO inhibitors, MAO-A or -B inhibitors, tricyclics, tetracyclics, SSRIs, NARIs, SNRIs, epinephrine, norepinephrine, clonidine and related compounds, long-acting benzodiazepines
* concomitant use of oral anticoagulants, anticonvulsants, type Ic antiarrythmics, lithium
* concomitant use of hypericum and SAMe
* concomitant use of digitalis preparations
* regular use of centrally-acting muscle relaxants
* concomitant use of strong analgesics, including tramadol, codeine or opiates
* any factor known to affect the HPA axis or autonomic function such as cigarette smoking (regularly over 25 cigarettes a day)
Effect of Remimazolam on Postoperative Nausea and Vomiting

The present trial is to study the effect of low dose remimazolam on postoperative nausea and vomiting (PONV) in patients at risks of PONV (women, postoperative use of opioid, nonsmokers) undergoing laparoscopic cholecystectomy.

Postoperative nausea and vomiting (PONV) is a common complication in patients undergoing general anesthesia. It is reported that PONV is observed in 50% of patients 24 hours after general anesthesia and upto 80% in high risk patients. The patients experiencing PONV may experience severe discomfort that it is important to prevent PONV. There are several prophylactic agents for PONV. 5 serotonin receptor antagonist(5-HT3 antagonist) is the most commonly used agent and other agents such as corticosteroid, neurokinin-1 receptor antagonist can also be used. Previous studies have reported the efficacy of benzodiazepine(midazolam) in a low targeting dose as a prophylactic agent of PONV. The efficacy of low dose remimazolam (short acting benzodiazepine) on PONV has not been evaluated.

According to Fourth consensus guideline for the management of postoperative nausea and vomiting (2020), three prophylactic anti-emetics are recommended for patients with three or more of the risk factors of PONV. As the patients included in our study have three or more of risk factors of PONV (women, postoperative use of opioid, nonsmokers), three prophylactic anti-emetics are recommended. Our center has routinely been using 5-HT3 receptor antagonist (ramosetron) and corticosteroid (dexamethasone) for women undergoing laparoscopic cholecystectomy. However, we still find many patients complaining nausea and vomiting after operation. Therefore, we are willing to investigate the low supplemental dose of remimazolam on the prophylaxis of PONV.

Eligibility Criteria:
Inclusion Criteria:

* women undergoing laparoscopic cholecystectomy under general anesthesia.

Exclusion Criteria:

* moderate to severe liver dysfunction (total bilirubin ≧ 3.0 mg/dL / aspartate aminotransferase(AST) or alanine aminotransferase(ALT) ≧ 2.5 times more than normal range)
* moderate to severe renal dysfunction (serum creatinine ≧ 2.0 mg/dL / end-stage renal disease undergoing hemodialysis)
* tolerance to benzodiazepines
* hypersensitivity to anesthetic drugs (Benzodiazepines, Propofol, Remifentanil, Fentanyl citrate, Rocuronium bromide, Flumazenil)
* acute angle glaucoma
* alcohol dependence
* Galactose intolerance, Lactase deficiency, glucose-galactose malabsorption
* pregnant, breast feeding women
* BMI \>35 kg/m2
* uncontrolled diabetes mellitus
Evaluation of the Contribution of Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy

The hypothesis of this study is that musculoskeletal point of care ultrasonography would support the GP's decision and ultimately improve patient management.

The aim of this study is to evaluate, in the context of suspected musculoskeletal abnormality, the contribution of musculoskeletal point of care ultrasonography to the general practitioner's overall decision-making strategy, defined according to the following 5 axes: diagnosis (I), therapy (II), patient orientation (III), prescription of complementary examinations (IV) and follow-up (V).

The study circuit takes place in a single visit.

1. The investigating physician suspects a musculoskeletal anomaly following an initial clinical examination.
2. The patient (who meets the inclusion criteria and has no non-inclusion criteria) gives consent to participate, after receiving information about the study.
3. The investigator fills in the e-CRF (appendix III), clinical examination, medical interrogation and his or her decisions according to the 5 axes, which cannot be modified, as the structure of the e-CRF planned in advance does not allow backtracking. The investigator performs the targeted musculoskeletal ultrasound with his or her personal ultrasound machine, following his or her usual operating procedure.
4. The investigator fills in the e-CRF with the results of the targeted ultrasound scan and indicates any modifications to the decision axes.

Eligibility Criteria:
Inclusion Criteria:

* Person who has received full information on the organization of the research and has given his/her consent
* Be over 18 years of age
* Present a symptomatology leading to suspicion of musculoskeletal pathology
* Be able to give consent
* Be affiliated to a social security scheme or benefit from such a scheme

Exclusion Criteria:

* Chronic inflammatory rheumatism (rheumatoid arthritis, spondylitis, psoriatic arthritis, rheumatoid pseudo-polyarthritis, juvenile idiopathic arthritis, lupus, etc.).
* Subjects benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice).
* Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L3212-1 and L3213-1.
* Pregnant women
* Nursing mothers
A Phase II Study of T-DXd Plus SRT in HER2-positive Breast Cancer Brain Metastases

This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed HER2 positive advanced breast cancer
* Age\>18 years.
* Brain metastases confirmed by enhanced brain MRI. Metastases number less than 15.
* KPS≥70 or KPS ≥60 with neurologic symptoms caused by BM
* Life expectancy of more than 6 months
* Prior therapy of oral dexamethasone not exceeding 16mg/d
* Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1.
* Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):

  1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L
  2. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases
  3. Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN)
  4. LVEF ≥ 50%
  5. QTcF \< 480 ms
  6. INR≤1.5×ULN，APTT≤1.5×ULN
* Signed the informed consent form prior to patient entry

Exclusion Criteria:

* Leptomeningeal or hemorrhagic metastases
* Uncontrolled epilepsy
* Severe or uncontrolled disease: severe cardiovascular disease, end-stage renal disease, severe hepatic disease, history of immunodeficiency, including HIV positive, active HBV/HCV or other acquired congenital immunodeficiency disease, or organ transplantation history, active infection, etc.
* History of allergy to treatment regimens
* Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
* Inability to complete enhanced MRI
* Not suitable for inclusion for specific reasons judged by sponsor
Association Between Balance and the Integrity of Cerebellar White Matter Tracts in a Healthy Population

The cerebellum is involved in regulating balance and walking and plays a crucial role in the locomotor adaptation and learning processes. This study aims to investigate the association between balance and the integrity of the cerebellar white matter tracts in a healthy population. Healthy participants will undergo four weeks of balance training. The investigators will analyze changes in the microstructural integrity of the cerebellar white matter tract before and after four weeks of balance training.

The cerebellum is involved in regulating balance and walking and plays a crucial role in the locomotor adaptation and learning processes. The cerebellum's intermediate zone, which receives afferent stimuli from the sensorimotor cortex (via the cortico-ponto-cerebellar tract) and peripheral muscles (via the dorsal spinocerebellar tract), contributes to maintaining body posture and regulating walking. Proprioceptive information from the peripheral muscles passes through the dorsal spinocerebellar tract, enters the ipsilateral cerebellar hemisphere via the inferior cerebellar peduncle, and finally projects to the contralateral motor cortex through the cerebello-thalamo-cortical pathways.

Diffusion tensor imaging (DTI) enables microstructural evaluation of the white matter tracts. Both diffusion tensor tractography, to determine the structural connectivity of the whole tract, and DTI-derived parameters, to determine the microstructural organization, can represent the integrity of the cerebellar white matter tracts.

The investigators will evaluate the motor-related white matter tracts, including the corticospinal tract, the cortico-ponto-cerebellar tract, the dorsal spinocerebellar tract, and the dentato-rubro-thalamo-cortical tract. Healthy participants will perform the four weeks of balance training, and DTI will be acquired before and after exercise. The investigators will analyze the DTI-derived parameters of the relevant white matter tracts and analyze the longitudinal changes. The investigators hypothesized that the four weeks of balance training would enhance the integrity of the cerebellar white matter tracts.

Eligibility Criteria:
Inclusion Criteria:

* Mini-mental state examination \>=26
* Independent outdoor ambulator

Exclusion Criteria:

* Men/women with any metal implants in their body
* A prior history of psychopathology or a neurological disorders
* A prior history of osteoporosis, advanced osteoarthritis (K-L grade \>=3), surgical history of hip or knee arthroplasty
* If any structural abnormalities are detected on their scan
Wide Awake Local Anesthesia No Tourniquet

The main objective is to assess patient's satisfaction regarding pure local anaesthesia and without use of a tourniquet (WALANT Technique) for trigger finger release surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients of age
* Isolated Trigger finger, diagnosis confirmed by sonography and with indication of surgical release
* Patients protected by health insurance
* Patients who have received proper information on the current research proctol, and did not refuse to enter the study

Exclusion Criteria:

* Hand vascular disorders ( History of finger replantation surgery, clinical signs of poor hand vascularization
* Hypersensitivy to Xylocain or Adrenalin or one of it's components
* Other surgical act planned to be performed during the same anaesthesia
* Pregnant or Breastfeeding women
* Patients of age and under the protection of a conservator, patients deprived of liberty
Decreasing Upper and Shoulder Pain After Laparoscopic Surgery

Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter hospitalizations, and less post-operative pain as compared with traditional laparotomies. However, there is marked interindividual variability of post-operative shoulder-tip pain following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and ranges from mild to severe. In some cases, it has been reported to last more than 72 hours after surgery.

The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic nerve irritation causes referred pain to C4. Therefore, the investigators should try to do is that if the investigators could reduce carbon dioxide retention in the pelvic cavity.

This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative should-tip pain following laparoscopic surgery.

This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative upper abdominal and shoulder pain after laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients receive benign gynecological laparoscopic surgery
* American Society of Anesthesiologists(ASA) physical status of patient classification I-II.

Exclusion Criteria:

* The procedure will be required to conversion to laparotomy
* Any cardio-vascular diseases
Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients

The aim of the current project is to validate whether chronic intake (24 weeks) roflumilast (PDE4 inhibitor) can improve cognition in patients with (amnestic) mild cognitive impairment (MCI) and in patients with mild dementia. The project will demonstrate whether episodic memory, but also attention, information processing or executive function improves with chronic administration of roflumilast in (a)MCI and mild dementia patients.


Eligibility Criteria:
Inclusion Criteria:

* 50 to 90 years of age
* Willingness (including the informal caregiver) to sign an informed consent
* Body mass index (BMI) between 18.5 and 35
* MMSE of 20 or higher
* Clinical (amnestic)MCI or mild dementia diagnosis
* Memory performance on the delayed recall in the clinically relevant 15 words VLT of 1 or more SD below the average
* Clinical dementia rating (CDR) scale total score of 0.5 or 1
* Fazekas of 2 or lower

Exclusion Criteria:

* Normal Pressure Hydrocephalus (NPH)
* Fazekas of 3 or higher
* Morbus Huntington
* Parkinson's disease
* HIV/AIDS
* Hepatitis C \& B
* Recent Transient Ischemic Attack (TIA) (\< 2 years)
* Cerebrovascular Accident (CVA) (\< 2 years)
* TIA/CVA followed by cognitive decline (within 3 months)
* Chronic Obstructive Pulmonary Disease (COPD) gold criteria 3 or 4 and severe asthma
* History of schizophrenia, bipolar disorder or psychotic symptoms not otherwise specified or previous treatment for these diseases (lifetime)
* Current radiotherapy
* Current affective disorder (i.e. anxiety or major depression)
* Cognitive problems due to alcohol abuse, brain tumor, epilepsy, encephalitis or lack of capacity to consent to participation.
* Current treatment with (or illicit use of) cannabis, opiates, benzodiazepines, MDMA and cocaine
* Patients with moderate or major liver impairments will be excluded (e.g. Child-Pugh B and C).
* Use of medication showing strong inhibition of either CYP3A4 or CYP1A2
* Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Patients participating in other drug studies
* If patient does not have the possibility to be accompanied by the same informal caregiver during all test days
The Effect of Physical Therapy Intervention on Motor Performance in Bhutanese Preterm Infants

The purpose of this randomized controlled trial is to assess if physical therapy intervention works well to improve motor performance in Bhutanese preterm infants.The main question the study aims to answer is:

Will physical therapy intervention improve the motor performance of preterm infants at 3 months of corrected age when compared to the preterm infants receiving standard care of parental education? In this study the motor performance of the preterm infants receiving physical therapy intervention and standard care will be compared.

After receiving parental consent, preterm infants meeting the eligibility criteria will be enrolled for the study. 28 preterm infants will be enrolled and followed up from 40 weeks till 3 months of corrected age.

The preterm infants in the intervention group will receive modified supporting play, exploration and early development intervention(SPEEDI) and the standard group will receive standard care. The intervention for both groups will be provided by the physical therapists. The SPEEDI intervention should be carried out by the parent for at least 20mins/day for 5 days in a week. The parent will be asked to bring the infants for monthly follow up.

The motor performance of the preterm infants from this two groups will be assessed at 40 weeks, 1, 2 and 3 months of corrected age. The measurement tool that will be used to assess the preterm infants are Test for Infant Motor Performance(TIMP) and Rapid Neurodevelopment Assessment(RNDA). The assessment will be performed by therapist who will be blinded to the group allocation.

The end point of the study is at 3 months of corrected age.

Eligibility Criteria:
Inclusion Criteria:

* Infants born between 28 -34 weeks of gestation
* Medically stable and off ventilator at the time of discharge from the hospital
* Parents who consent to come for follow up

Exclusion Criteria:

* Cortical blindness or retinopathy of prematurity causing blindness
* Musculoskeletal/congenital abnormalities
* Brain injuries including intra-ventricular hemorrhage (grade 3 and above), hypoxic ischemic encephalopathy and hydrocephalus
* Genetic syndrome
* Family who do not consent
* Parent with physical and psychological problems
* Infants with medical devices such as NG tube and gastrostomy
* Infants who have undergone major surgery
A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin

The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin.


Eligibility Criteria:
Inclusion Criteria:

* from 18yrs to 80yrs , man and women
* the patient who are taking rifampicine over 2weeks
* the patient sign on the concent form

Exclusion Criteria:

* the patient have experience to take medication that have an effect on renal function
* the patient have hypersensitivity to colchicine
* At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP \<= 100 mmHg or \>=160 mmHg and DBP \<=60 mmHg \>=100 mmHg, or Heart rate \< 40 beats/min or \> 90 beats/min
* uncontrolled hypertension
* serum albumin \< 3.5, \> 5 g/dL
* acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL
* the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine.
* the patient who should take azathioprine, mercaptopurine, cyclophosphamide, Losartan, benzbromarone,fenofibrate,furosemide ,probenecid
* the patient who had taken part in the other study within 3months
* the patient who had gotten blood transfusion
* pregnant, breast feeding
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years

This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects \>15months to \<18years in good health, available for entire study period and reachable by phone, parents/legal guardian able and willing to complete all study procedures, written documentation from health professional showing prior vaccination with Prevnar (except for group 4).

Group 4 only:

* Negative urine pregnancy test for female subjects who are menstruating.

Exclusion Criteria:

* Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component , bleeding diathesis, received blood transfusion or blood related products, immune deficiency,congenital malformation.

Group 4 only:

* Previous vaccination with Prevnar or any other pneumococcal vaccine.
* Pregnant or breastfeeding adolescent females.