cyrilzakka/clinical-trials huggingface dataset:
Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients

The objective of MER-101-03 is to examine the effects of two different dosing regimens of MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be enrolled will be those who have not received any previous bisphosphonate therapy. The study will be carried out on prostate cancer patients who are no longer on hormone therapy. Treatment in the study will be for a 2-month period.


Eligibility Criteria:
Inclusion Criteria:

* Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray.

Exclusion Criteria:

* Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)
Disconnection Technique With a Bronchial Blocker for Improving Lung Deflation

One lung ventilation (OLV) is accomplished with a double lumen tube (DLT) or a bronchial blocker (BB). In this study, the investigators compared the effectiveness of lung collapse using DLT, BB with spontaneous collapse, and BB with disconnection technique.

In selecting this maneuver of OLV, lung collapse is a major concern because it permits adequate surgical exposure. Although once lung deflation was achieved, the overall clinical performance appears to be similar, BB takes longer to deflate the operative lung and there is some conflict reports as to BB provides a similar degree of lung deflation compared to that of DLT.

The aim of this study was to compare the efficacy of BB and DLT for achieving lung collapse, and to evaluate the efficacy of disconnection technique with monitoring the carbon dioxide trace on a capnograph in BB. The investigators further evaluated the disconnection time, which is the time to loss of carbon dioxide trace on the capnograph, needed to facilitate lung collapse.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing thoracic surgery for which OLV is required

Exclusion Criteria:

* Patients with an anticipated difficult intubation with infectious or bleeding lung lesions are excluded.
The Effect of Meal Replacement on the Time to Reach the Blood Glucose Target in Patients With Type 2 Diabetes Mellitus

This study was designed as a randomized controlled study. It was planned to include 100 patients with type 2 diabetes who received short-term intensive insulin therapy and randomly divided them into a meal replacement intervention group and a conventional diabetes diet group according to 1:1. Both groups were treated with short-term intensive insulin therapy to control blood sugar. .


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetic patients who meet the diagnosis of type 2 diabetes (CDS2020) and are willing to receive intensive insulin hypoglycemic therapy;
2. Glycated hemoglobin A1c≥7.5%;
3. Age between 18-70 years old, body mass index (BMI) 20-35kg/m2;
4. Be able and willing to cooperate with diet and exercise and monitor blood sugar in accordance with the project regulations, and agree to sign the informed consent.

Exclusion Criteria:

1. Diagnosed as type 1 diabetes or special type of diabetes;
2. Allergic or intolerable to the meal replacement food used in the study;
3. Acute complications of diabetes (including DKA, HHS, lactic acidosis)
4. Severe microvascular complications: proliferative retinopathy; urine AER\>300mg/g or urine protein positive, quantitative\>0.5g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy;
5. Significant macrovascular complications: patients with acute cerebrovascular accident, acute coronary syndrome, peripheral arterial disease requiring vascular intervention or amputation within 12 months before enrollment;
6. Serum creatinine clearance rate is less than 50ml/min/1.73m2 (calculated according to CKDEPI formula), alanine aminotransferase ≥ 3 times the upper limit of normal, and total bilirubin ≥ 2 times the upper limit of normal;
7. The cumulative time of using drugs that may affect blood sugar for more than 1 week within 12 weeks, such as oral/intravenous glucocorticoids, GH, estrogen/progestin, high-dose diuretics, antipsychotics, etc.;
8. Systemic infection or serious concomitant diseases; patients with malignant tumors or chronic diarrhea;
9. Uncontrolled endocrine gland dysfunction;
10. Mental or communication disorders;
11. Pregnant and lactating women;
12. The subject is not cooperative, or the investigator judges that it may be difficult to complete the investigator;
13. Other circumstances judged by the investigator to be unsuitable for inclusion.
A Study on Brain Activity During Transcranial Direct Current Stimulation in Stroke Patients

The purpose of this study is to identify the characteristics of neural plasticity seen in stroke patients by measuring the changes in brain activity during stimulation using functional near-infrared spectroscopy (fNIRS) when applying transcranial direct current stimulation (tDCS) for the purpose of enhancing finger function.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral stroke patients
* Chronic patients over 6 months after onset
* Subcortical stroke
* Patients with the movement of fingers

Exclusion Criteria:

* History of psychiatric disease
* Significant other neurological diseases except for stroke
* Difficult to perform this experiment
* Patients with metal implants
* History of epilepsy
* Pregnancy
* Skin defect at the site of electrode attachment
Relationship of Motor Skill Competency and Physical Fitness to Physical Activity in Elementary School Students

This study examined how well elementary students demonstrated motor skill competency as a result of participating in the evidence-based quality physical education program and investigated relationships between levels of health-related physical fitness and physical activity in school-aged children.


Eligibility Criteria:
Inclusion Criteria:

* K-5 th grade students who are enrolled in 9 elementary schools in Southeast Michigan.

Exclusion Criteria:

-
Use of Mobile Technology by Community-Based Health Workers to Promote Maternal and Child Health in Bihar, India

This study is designed to evaluate the impact of use of mobile technology by community-based health workers on health-promoting behaviors among women related to reproductive, maternal, newborn and child health and nutrition in Bihar, India.

The intervention was funded by the Bill and Melinda Gates Foundation (BMGF) and in collaboration with CARE was implemented from 2012 to 2014. Health sub-centers in the catchment areas of four blocks (sub-districts) of the district of Saharsa were randomly assigned to treatment or control arms (35 sub-centers were assigned to each). Data were collected in the Intervention and Control areas from mothers of infants 0-12 months at baseline and at 2-year follow-up, to assess the intervention's effects on quality and quantity of FLW home visits, postnatal health behaviors, and among older infants/toddlers, complementary feeding and vaccination. Difference in difference analyses were used to assess outcome effects in this quasi experimental study.

The ICT-CCS intervention was implemented in areas where the BMGF-funded Ananya program (official title: Bihar Family Health Initiative) was also being implemented. Thus, the impact is of the \[ICT-CCS intervention + Ananya\] versus \[Ananya alone\]. The Ananya program was developed and implemented via a partnership of BMGF, CARE, and the Government of Bihar. The ultimate purpose of Ananya was to reduce maternal, newborn, and child mortality; fertility; and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to build front line health worker (FLW) capacities and reach to communities and households, as well as to strengthen public health facilities and quality of care to improve maternal and neonatal care and health behaviors, and thus survival. It was implemented from 2012 to 2014. Eight focal districts in western and central Bihar received Ananya, while 30 districts did not.


Eligibility Criteria:
Inclusion Criteria:

* Mothers of infants 0-12 months residing in the catchment area of the subcenters

Exclusion Criteria:

-
Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome

As the HGT-HIT-046 (NCT01506141) and SHP609-302 (NCT02412787) studies will be closed, this post-trial access (PTA) program provides TAK-609 to participants in these studies for whom the benefit:risk ratio of continued treatment with idursulfase-IT remains positive.


Eligibility Criteria:
Inclusion Criteria:

1. Participants will have completed the treatment period of the HGT-HIT-046 (NCT01506141) or SHP609-302 (NCT02412787) study prior to the first dose on this program.
2. Participant and/or a parent(s)/legal guardian is informed of the nature of this compassionate post-trial access program and can provide written informed consent for themselves or the child to participate (with assent from the child when appropriate prior to treatment).

Exclusion Criteria:

1. Participant has a condition that in the opinion of the treating physician may compromise their safety.
2. Participant has a known hypersensitivity to idursulfase-IT or its components.
Clinical Trials on Evaluate the Red Ginseng and Fermented-Red Ginseng Affect to Drug Metabolizing Enzyme and Transporter in Healthy Volunteers

The purpose of this study is to evaluate the possibility of drug interactions before and after taking red ginseng or fermented-red ginseng by estimating metabolic rate of indicator drugs for cytochrome P450 and P-glycoprotein.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 20 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \> 45 kg.
* An informed consent document signed and dated by the subject.
* Subject who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
* Any condition possibly affecting drug absorption (e.g. gastrectomy)
* History of regular alcohol consumption exceeding 21 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of Screening
* Participating in a bioequivalence study or other clinical study within 3 months preceding the first dose of study medication
* Screening sitting blood pressure \> 160 mm Hg (systolic) or \>90 mm Hg (diastolic), following at least 5 minutes of rest.
* History of significant alcohol abuse or drug abuse within one year prior to the Screening
* Use of any drugs known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing
* Smoking over 20 cigarettes per day
* Use of prescription or nonprescription drugs and dietary supplements within 10 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
* Blood donation within 2 months prior to dosing, or plasma donation within 2 weeks prior to dosing
* Unwilling or unable to comply with the Lifestyle guidelines described in this protocol
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
* Subjects who are hypersensitive to investigational drugs or related compounds
* Subjects with hereditary disease of galactose intolerance, Lapp lactase deficiency or gulucose-galactose malabsorption
* Subjects who are decided incongruity to participated in this study by investigators
Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients--Pakistan

The purpose of this study is to learn whether bismuth subsalicylate can reduce use of antibiotics among adults with diarrhea in Pakistan.


Eligibility Criteria:
Inclusion Criteria:

* Persons aged 15 - 65 years old
* Presenting with mild to moderate, non-bloody, acute diarrhea (≥3 loose stools/day for \<3 days) to participating health care settings
* For whom the study physicians recommend antimicrobial treatment

Exclusion Criteria:

* Is pregnant
* Requires hospitalization
* Has signs or symptoms of septicemia
* Has a primary complaint of another acute illness
* Has a serious chronic illness
* Has an allergy to aspirin
* Has been exposed to antimicrobial or antidiarrheal medications within 72 hours of enrollment
* Previously enrolled in study
Use of Local Analgesia With Epinephrine During Total Hip Arthroplasty (THA)

The aim is to determine if the use of infiltration with an adrenalin solution in the operative field of Total Hip Arthroplasty (THA), allays a significant reduction of the cumulated volume of bleeding (pre and post operative) without increasing the per and post operative risks. At the same time, the effect on the post operational pains is evaluated.

This prospective randomized study compares a population receiving a local anaesthetic (ropivacaine, adrenalin and physiological serum) in the operative field to a population undergoing a standard protocol.

The cumulated volume of bleeding per and post operative are recorded and complete blood count (CBC).

Eligibility Criteria:
Inclusion Criteria:

* Primary total hip arthroplasty
* Age between 50 and 85

Exclusion Criteria:

* fracture of the femoral neck
* patients with contraindications for local anaesthesia
The Effects Of Anticholinergic Burden On Daily Living Activities In Elderly Patients

The anticholinergic burden was calculated based on the medications that the patients had used for more than 10 days. Short-term medications used by patients were not evaluated. Among all the medications used by the patients, those with anticholinergic effects were scored according to the scale, and the total anticholinergic burden was calculated by adding them up. Those who had no anticholinergic score were considered to have no anticholinergic burden.

The study cohort will be stratified into two cohorts, distinguished by the presence or absence of anticholinergic burden. To evaluate the impact of anticholinergic burden on daily living activities and instrumental ADL, the groups will be compared with respect to hand grip strength and walking speed.In this study, the anticholinergic burden will be calculated based on medications used by the patients for more than 10 days, excluding short-term medications. Each medication with anticholinergic effects will be assigned a score according to a scale, and the total anticholinergic burden will be determined by summing up the scores. Patients without any anticholinergic score will be classified as having no anticholinergic burden.

The study cohort will be divided into two groups based on the presence or absence of anticholinergic burden. To assess the impact of anticholinergic burden on daily living activities (ADLs) and instrumental ADLs, the groups will be compared in terms of hand grip strength and walking speed.


Eligibility Criteria:
Inclusion Criteria:

* Being over 65 years old
* Patients without a diagnosis of dementia and with MMSE\>24
* Patients who can communicate (without hearing or visual problems)
* Those who give written consent to participate in the study

Exclusion Criteria:

* Patients with a diagnosis of dementia at their initial visit,
* Bedridden patients (those with visual impairments)
* Patients with walking difficulties (due to pain, prostheses, visual problems, etc.), vitamin D deficiency (10) (20ng/dl\>) or those who use assistive devices (walker, cane, etc.) or those with sequelae of cerebrovascular events or hip fractures.
* Patients with a diagnosis of delirium,
* Those who underwent major surgery in the last 6 months,
* Those who experienced cardiac or cerebrovascular events during the follow-up period,
* Patients with infectious diseases,
* Those who did not sign or withdrew their consent form.
Gastroparesis Registry 2

To expand a registry of patients for the study of the epidemiology, etiology, and degree of morbidity associated with gastroparesis.

The Gastroparesis Registry 2 (GpR 2) will enroll new patients and patients from the initial NIDDK Gastroparesis Clinical Research Consortium Gastroparesis Registry (GpR) of gastroparesis patients which was initiated in February 2007 and completed in March 2011.

To continue to follow and expand the data collections of a well-characterized cohort to further define the natural history and clinical course of gastroparesis.

To provide a reliable source for recruitment of well-characterized patients with gastroparesis for therapeutic clinical trials, pathophysiological, molecular, histopathologic, or other ancillary studies. These subsequent clinical trials or ancillary studies will be conducted under separate study protocols with separate consent processes.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of gastroparesis of at least 12 weeks duration (do not have to be contiguous) with varying degrees of nausea, vomiting, early satiety, post-prandial fullness, and/or abdominal pain
* An etiology of either diabetic, idiopathic, or post-Nissen fundoplication gastroparesis
* Gastric emptying scintigraphy of solids and liquids test using 4 hours Egg Beaters® protocol within the last 6 months with either:

  * Abnormal gastric emptying rate defined as an abnormal 2 hour (\>60% retention) and/or 4 hour (\>10% retention) result based on a 4-hour scintigraphic low fat Egg Beaters® gastric emptying study performed at a GpCRC clinical center.
  * Patients with a normal gastric emptying rate but with symptoms of gastroparesis may be enrolled and classified as possible gastroparesis or gastroparesis-like with normal gastric emptying
* Age at least 18 years at initial screening visit
* Upper endoscopy results within last 2 years

Exclusion Criteria:

* Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)
* Presence of other conditions that could explain the patient's symptoms:
* Pyloric or intestinal obstruction as determined by endoscopy, upper GI series or abdominal CT scan
* Active inflammatory bowel disease
* Known eosinophilic gastroenteritis
* Primary neurological conditions that could cause nausea and/or vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
* Acute liver failure
* Advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7 )
* Acute renal failure
* Chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis
* Total or subtotal (near complete) gastric resection, esophagogastrostomy, gastrojejunostomy, or gastric bypass. Note: patients with prior fundoplication will be eligible for enrollment.
* Any other plausible structural or metabolic cause
* Any other condition, which in the opinion of the investigator would interfere with study requirements
* Inability to obtain informed consent
Internet Delivered Self-Help CBT for Insomnia

The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia. In this study all participants receive an online self-help CBT manual consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Insomnia
* Access to the internet

Exclusion Criteria:

* Alcohol or substance abuse
* Being suicidal
* Sleep apnea
* Schizophrenic or having a psychosis disorder
Evaluation of Efficacy of Lumbar Plexus Bloc After Hip Surgery

Compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. Each group randomized, includes 30 patients. block performed preoperatively Surgery under general anesthesia. Postoperative evaluation of pain (VAS) as first endpoint, and also morphine consumption via PCA device. Follow-up : 24h.

Expectation : sizeable reduction of pain with block, of duration.

Compare lumbar plexus block (randomized)

* ropivacaine 0.475%, 0.4 ml/kg
* saline 0.4 ml/kg . Each group includes 30 patients.

Block performed preoperatively.

Surgery under general anesthesia (sufentanil, propofol, atracurium ; maintenance : sevoflurane and nitrous oxide in O2. Sufentanil added peroperatively as clinically needed.

Postoperative evaluation of pain (VAS, by an independant blind observer) as first endpoint, and also morphine consumption via PCA device.

Adverse effects (nausea, vomiting, etc) recorded

Follow-up : 24h. Expectation : sizeable reduction of pain with block, of duration.

Eligibility Criteria:
Inclusion Criteria:

* adults
* ASA 1-3

Exclusion Criteria:

* cognitive impairement
* ASA IV
Comparison Of Efficacy Of Combination Of TAM Formula Vs Kligman Formula For Melasma.

This study would offer the participants about the knowledge of these formula in the treatment of melasma and help the investigators in incorporating and updating the management protocols in medical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 25-65 years of age, either gender having melasma for over one month will be included in the study
* Exclusion Criteria:

  * Pregnancy, breastfeeding, taking birth control pills or plans to become pregnant during the study
  * History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis
  * History of skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy
  * History of uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
  * History of sensitivity to hydroquinone or Retin-A
  * History of evidence of a compromised immune system or hepatitis
Cutaneous Leishmaniasis Diagnostic Study

The performance of the CL Detect Rapid test will be tested in individuals with suspected cutaneous leishmaniasis in Ethiopia using both skin slit and dental broach samples against a combined reference of microscopy and PCR. Alternative sampling methods will also be evaluated.

Cutaneous Leishmaniasis is common in Ethiopia and mainly affects the poor living in rural areas. Diagnosis of CL routinely uses invasive skin slits which are examined with microscopy, requiring trained staff and an equipped lab. A new rapid diagnostic test for CL which may be used in the field has been developed and validated in several countries where other Leishmania species are present. Less invasive tape sampling has also become available. Whether this new RDT and alternative sampling methods can be used in Ethiopia is unclear.

The performance of the CL detect Rapid Test against a combined reference (microscopy and PCR) and alternative sample collection methods will be tested in CL suspected individuals in North-West Ethiopia in a cross-sectional study.

Eligibility Criteria:
Inclusion Criteria:

- Clinical suspicion of CL

Exclusion Criteria:

* ≤ 2 years of age
* Not willing or able to provide consent/assent
* CL presentation with only lesions for which skin slit samples cannot be obtained (e.g. eyelids)
* Co-morbidity with visceral leishmaniasis
* On CL treatment at time of enrollment