cyrilzakka/clinical-trials huggingface dataset:
Long-term Effect of Electromagnetic Field in Treatment of Patients With Osteopenia or Osteoporosis

Osteoporosis is the most prevalent metabolic bone disease. Although osteoporosis is widely considered to be much more prevalent in women approximately 39% of new osteoporotic fractures estimated to have occurred worldwide in 2000 were in men. A number of studies investigate the effect of physical therapy modalities in treatment of osteoporosis. The use of pulsed electromagnetic field (PEMF) represents an attractive alternative for osteoporosis.

Previous studies suggested that pulsed electromagnetic field could be beneficial for increase bone mineral density in osteoporotic patients, but there is a lack of knowledge about the long term effect on several parameters.

Objectives: This randomized controlled study aims to investigate the long term effect of pulsed electromagnetic field (PEMF) on bone mineral density (BMD) and bone markers; also to be used as treatment intervention of osteopenia or osteoporosis through studying the effect of low intensity, low frequency, single pulsed electromagnetic fields. Methods: One hundred and twenty male patients with osteopenia or osteoporosis will participate in this study, their age ranges between 30-60 years. They have BMD T-scores ≤ - 1.5. All patients will be randomized into one of three groups. Group one received PEMF and exercise (PEMF+EX), group two received placebo PEMF and exercise (PPEMF+EX) and group three will be treated by PEMF alone (PEMF). The exercise training program will include treadmill and aerobic exercises for hip and upper limb will be performed for 50 minutes.PEMF was administered to the whole body for PEMF groups using a 1.8×0.6m mat 30 minutes/day, 3 times/week for 3 months. Dual-energy X-ray absorptiometry (DEXA) will assess Bone mineral density BMD (g/cm2), bone mineral content (BMC), T-Score and Z-Score at the lumbar spine, proximal femur and forearm region, bone markers (25-hydroxy Vit D , Total, undercarboxylated Ostocalcin, Parathyroid Hormone, Total and Ionized calcium and Alkaline Phosphatase (ALP), also will be measured. The assessment will be done at baseline, after treatment (12 weeks) and after 6 months as follow up. The data will be analyzed using repeated measures Analysis of variance (ANOVA) for comparison between pre-treatment and post treatment measurement intervals. One-way ANOVA is used to compare between each treatment interval in treatment groups at pre-test and post treatment measurement intervals. The level of significance is set at 0.05 for all tests.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a T-scores of ≤ ˗1.5, all patients received the same medical treatment for osteoporosis and the same average blood glucose level, sufficient ability to understand the nature and potential risks of the study.

Exclusion Criteria:

* Diabetes mellitus, ischemic heart disease, arrhythmia, uncontrolled thyroid disease, cardiac pacemaker, tuberculosis, neuropsychiatric disorders (dementia, cerebrovascular disease, alcohol abuse, severe depression, panic disorder, bipolar disorder, or psychosis), and malignancy.
Optimizing HIV Virologic Outcomes for Pregnant Women in Uganda

The ENHANCED -SPS study is a before and after cluster randomized trial that will be conducted in 14 public health facilities providing HIV care in Southwestern Uganda. The study will evaluate the effectiveness of a multi-component intervention package that targets barriers to achieving optimal viral suppression among pregnant and postpartum women infected with HIV. This will be in two phases; In Phase 1 ("Before"), all 14 clinics will have a baseline assessment of standard of care VL procedures and assess the barriers and facilitators to viral suppression for a period of 3 months. In Phase 2 ("After"), 7 clinics randomized to control arm will continue to experience standard of care counseling procedures, and 7 clinics randomized to intervention will initiate the ENHANCE-PS intervention. The Phase 2 ("After") phase I will last at least 12 months.

The Investigators will test the hypothesis that the Enhanced viral load (VL) counseling and standardized peer mother support (ENHANCED-SPS) intervention will increase viral load suppression among HIV-infected pregnant and post-partum women and increase retention of mothers in care hence resulting in reduced risk of vertical transmission in south western Uganda.

Specific objectives are as follows:

1) To evaluate the effectiveness of an enhanced VL counseling and standardized peer mother support intervention on viral suppression among HIV infected pregnant women at 12 months of follow up; 2) To evaluate the effect of the enhanced counseling and peer support intervention on retention in care at 18 months postpartum follow up; The investigators will randomize 14 HIV clinics to the ENHANCED-SPS multi-component intervention vs. standard of care procedures (intervention=7 clinics and control=7 clinics,n=70 mothers/health facility) ;3) To assess the facilitators and barriers of VL and enhanced VL counseling and peer mother support intervention at 9 \& 18 months of follow up.This will consider both patient and providers perspectives of the intervention implementation

Eligibility Criteria:
Inclusion Criteria:

1. All Pregnant women and breastfeeding mothers enrolled in the mother baby care points/HIV clinics with documented HIV infection
2. . HIV infected Pregnant women reporting for their first ANC within the study clinics or newly identified HIV positive mothers from the ANC clinics/breastfeeding

   Exclusion Criteria:
3. . All women who will be critically ill and unable to communicate
4. . Those not willing to consent to participate in the study
5. . Women who will not be able to understand all information concerning the study
NAS Treatment - Opiate Versus Non-Opiate

The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine is another drug, but is different from morphine. It is also used for babies, and even adults for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if one may be better than the other.

Withdrawal from drugs, called Neonatal abstinence syndrome (NAS), is a group of symptoms that occurs to babies whose mother took or used drugs (prescription, addicting, illegal, pain pills, or drugs for addiction treatment) during pregnancy. Medicines the mother takes while pregnant, the baby also takes. Babies may experience withdrawal after delivery, and may need treatment. There are different ways to treat babies with withdrawal - about 50% of doctors use morphine, an opiate, to treat these babies, the rest uses other drugs, like clonidine and phenobarbitol.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to Neonatal Intensive Care Unit (NICU)- Gestational age (GA) \>or= 35 wks
* Known prenatal opiate exposure (maternal history, positive opiate screen, positive neonatal urine or meconium screen)
* Symptomatic with Finnegan Neonatal Abstinence Scores meeting NICU protocol for treatment

Exclusion Criteria:

* Seizures
* Major congenital malformations
* Unlikely to survive
* Parents not able to understand English
A Controlled Study to Assess the Effectiveness of Aerobic Exercise as an Augmentation Therapy for Inpatients With Major Depressive Disorder

We will evaluate the effect of a short-term aerobic exercise program as an adjuvant treatment in patients with depression undergoing standard clinical antidepressant medication therapy as compared to the effect of stretching exercise. In addition, the effect of exercise on plasma biological markers will be examined and observed changes correlated with clinical antidepressant effects. We hypothesize that the aerobic exercise group will achieve a significantly higher response rates of depressive symptoms, will also have a greater degree of change in the plasma markers, than the control stretching group.

The patients will be randomly assigned to 3 weeks of augmentation therapy (in addition to the antidepressant medication, which will be continued) with either: 1) aerobic exercise or 2) stretching exercise (control group). Random assignment to each group will be stratified according to previous response to treatment as determined by a psychiatrist and review of the Antidepressant Treatment History Form (ATHF) and by gender.

Severity of depression will be rated at the first baseline visit and every week during the exercise program using the Hamilton Depression Scale (HAM-D 21 items), Clinical Global Impression Scale (CGI) (observer-rated) and Beck Depression Inventory (BDI) and Visual Analog Scale (self-rated).

Blood samples will be obtained four times during the study - before and after the first exercise session and before and after the last exercise session. The blood taken before the exercise sessions will be used to assay thyroxine, cortisol, insulin, opioid peptides and cytokines such as IL-6 and TNF-α in the plasma. The blood taken after the exercise sessions will be used to re-examine variables expected to be altered immediately after exercise such as cortisol, opioid peptides, catecholamines and cytokines.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Major Depressive Episode (MDE) in the context of MDD according to DSM-IV criteria, without psychotic features.
2. Hamilton Depression Scale (21 items, HAM-D) total\>14 with item 1 (depressed mood) \>2.
3. Physical capability to perform aerobic exercise or stretching exercise.
4. Competent and willing to give written informed consent

Exclusion Criteria:

1. Current, significant physical illness that will preclude exercise training.
2. Any physical impairment that can interfere with exercise training.
3. Current psychotic features.
4. Treatment with electroconvulsive therapy.
The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease

Levodopa and non-ergot dopaminergic agonists such as pramipexole are both recommended as the first-line symptomatic treatment for early untreated Parkinson's disease (PD), previous clinical trial indicated that initial pramipexole owns advantage over levodopa regarding motor complications, on the contrary, less adverse effect like freezing and severe somnolence favors initial treatment of levodopa. Thus, it remains controversial that initiation of which medication will be better for those patients with early PD.

Parkinson's disease-related spatial covariance patter (PDRP) is a new biomarker which can represent the network activity of brain and severity of PD. Based on the literatures and our previous data, the investigators hypothesize that PDRP will be served as a biomarker to help us evaluate and compare the effect of levodopa or pramipexole on the progression of PD, which might be able to provide further evidence for clinicians to address the above critical issue.

CALM-PD study found that Pramipexole can reduce the occurrence of motor complication compared with Levodopa used as initiative treatment, but it still remains debatable that initiation of which medication will be better for those patients with De Novo PD.

PDRP (Parkinson's disease-related spatial covariance pattern) is a biomarker which can represent the network activity of cortico-striato-pallido-thalamocortical pathways and highly reproducible with stable network activity in individual subjects. The study published in "J Neuroscience" in 2010 showed that the abnormal PDRP antecede the appearance of motor signs by about 2 years, indicating PDRP might be a very promising biomarker for identifying PD at its early stage. Moreover, PDRP is able to represent the progression and severity of PD as well. It was reported that Levodopa can reduce the PD-related network activity, and the degree of network suppression correlates with the clinical improvement. However, there is no study currently showing the impact of pramipexole on brain PDRP network compared with levodopa as initiative treatment.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic Parkinson's disease meeting United Kingdom (UK) brain bank criteria
* De Novo
* Hoehn\&Yahr staging (H\&Y) I-II

Exclusion Criteria:

* Atypical Parkinsonism
* Pregnant or breast-feeding women
* those with abnormal Liver/kidney function
* those participating other clinical trials within 30 days before being enrolled for this trial.
Pilot Study of AuTNA I

The objective of the study is to evaluate:

1. Safety of AuTNA I for subretinal implantation in patients with retinitis pigmentosa;
2. Efficacy of AuTNA I for subretinal implantation in patients with retinitis pigmentosa.

In this study, AuTNA I (nanoparticle-decorated TiO2 Nanowire Arrays), which is designed to replace the damaged photoreceptors in RP patients, was implanted in one eye of the subjects. The change or improvement in the visual acuity of the subjects, as well as the potential side effects, was then fully evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-65 years of age.
2. Clinically diagnosed as retinitis pigmentosa (one of the following two conditions):

   ① typical triadfundus manifestations: "osteoblastic" pigmentation of retina, arterial stenosis, and waxy atrophy of optic disc.

   ② typical fundus changes with both a and b, with or without c:
   1. poor night vision before vision loss;
   2. standard 5 ERG examination showing more severely damaged scotopic response than photopic, even non response
   3. impaired peripheral visual field in perimetry (when the patient's vision permits).
3. No or suspicious light perception in the eye for AuTNA I implantation.
4. Intact inner retinal structure on OCT. No macular retinal or choroidal neovascularization.
5. Voluntary to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Entities that might interfere with the functioning of AuTNA I, e.g. open ocular trauma, retinal detachment, glaucoma, severe uveitis, etc.
2. Uncontrolled systemic diseases including hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg), diabetes (blood glucose ≥8.0mmol/L with medication);
3. Allergic constitution.
4. Entities that might prevent the observation of the fundus, e.g. corneal opacity, etc.
5. Ocular disease not suitable for undertaking the implantation surgery, e.g. corneal ulcers, etc.
6. Habits of rubbing the eyes.
7. Compromised liver function (ALT and AST 1.5 times over the normal limits), renal function (Cr 1.5 times over the normal limits), coagulation function (APTT 1.5 times over the normal limits).
8. Pregnancy, lactating or planning to be pregnant within 6 months.
9. History of epilepsy or serious psychiatric diseases.
10. Other local or systemic diseases that may affect the vision.
11. Participation in other clinical trials within 1 month before this study.
12. Other conditions that the researcher found imporper to be included into this study.
Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone

Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy

Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy; RCT

This reseach focus on the medical abortion in the early pregnancy loss. The target population is 70 patients (35 per group). We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.

In control group we give only Misoprostol 800 mcg SL. Then, thepatien will follow up on day 7, TVS will be done to diagnose the complete abortion.

The primary outcome is rate of complete abortion between 2 groups. The secondary outcome is side effect of letrozole and induced to abortion time.

Eligibility Criteria:
Inclusion Criteria:

* Diafnoed Early pregnancy loss by TVS according to ACOG Practice bulletin 2018
* GA \<= 14 weeks
* Os open \<= 1 cm and no conceptus per os
* Hematicrit \>= 30
* Systolic blood pressure \>= 95 mmHg
* Informed consent done and can follow up and comunicate in Thai language

Exclusion Criteria:

* Allerguc to Letrozole or Misoprostol
* Intrauterine contraceptive device use
* Breast feeding
* Diagnoed with ectopic pregnancy or undiagnoed adnexal mass
* Severe or recurrent liver disease or AST or ALT more than or equal to 3 times of upper normal limit
* Multiple pregnancy
* Myoma uteri that involves the endometrium ex. Submucous myoma uteri
* Thromboembolism or has a history of thromboembolism
* Serum creatinine \>= 2
Effect of Coffee Consumption on Intestinal Motility

Randomized controlled trial in Obstetrics and Gynecology department (MULTI-CENTRIC).To measure the effect of coffee consumption on intestinal motility after caesarean section for the patient who fulfills the criteria. Then they will be randomized to 3 groups. The primary outcome and secondary outcome will be measured.

Randomized controlled trial. Participants who fulfill the inclusion criteria (elective caesarian section, singleton pregnancy, term, viable fetus), and exclusion criteria (medical disorders, known intestinal diseases, past history of intestinal surgery, intraoperative diagnosis of extensive adhesion, intraoperative complications "e.g., intestinal injury and ureteric injury intraoperative complication that can lengthen the operation time, postoperative complications like anesthesia complication and electrolytes imbalance ) Then they will be randomized to 3 groups. Group 1, will start to drink coffee 6 hours postoperative for maximum 3 doses (100ml), 8 hours apart, diet will start after 1st audible bowel sound.

Group 2, will drink water 6 hours postoperative. Diet will start after 1st audible bowel sound.

Group 3 is the control group and they will be (NOTHING PER ORAL) for 24 hours on intravenous fluid (3 LITRES/24 HOURS). Diet will start after 1st audible bowel sound.

Primary outcome: passage of stool. Secondary outcome: passage of flatus, audible intestinal sound time, feeding time, pain scale by Visual Analogue Scale (VAS), amount, and type of analgesia needed, breastfeeding time, mobilization and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* elective caesarian section, singleton pregnancy, term, viable fetus

Exclusion Criteria:

* medical disorders, known intestinal diseases, past history of intestinal surgery, intraoperative diagnosis of extensive adhesion, intraoperative complications "e.g., intestinal injury and ureteric injury intraoperative complication that can lengthen the operation time, postoperative complications like anesthesia complication and electrolytes imbalance )
Rehabilitation of Conversion Gait Disorder

Evaluating the effects in functional status after three weeks of cognitive - and behavioural rehabilitation on patients with gait disorder. The patients are followed up as after 1 and 12 months to study if any improvement is still present. The patients are being recruited from neurological units. The intervention is explanation of symptoms, positive reinforcement of normal behaviour and absence reinforcement of dysfunctional behaviour. In addition the study aims at describing typical gait patterns at patients with gait disorder by using biomechanical measurements (EKG).

Patients are being recruited from neurological unit/ div and out patients department of SSR and are randomized to treatment or control group. Essential gait disorders do to conversion symptoms and willingness to participate in either of the two groups with informed consent are required.

Eligibility Criteria:
Inclusion Criteria:

* To determine the changes in functional status after three weeks of multidisciplinary rehabilitation in patients with conversion walking disorder.

Exclusion Criteria:

* Essential gait disorders do to conversion symptoms and willingness to participate in either of the two groups with informed consent are required.
Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19

Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.

Reducing viral load is potentially key to reducing viral transmission between humans. Observational data suggests HC and AZ may reduce the viral load. In this study we will randomise ambulatory patients with Covid 19 (confirmed by PCR in combination with clinical symptoms) to receive HC/AZ or HC/placebo or placebo for 7 days. On days 2-14, participants will be reviewed by a member of the research team and samples will be obtained for viral load, an ECG recorded and physical examination performed. On days 15-20, participants will be reviewed by telephone using a semi structured questionnaire. On day 21 participants will be examined in person and an oronasopharyngeal swabs obtained for PCR analysis. Participants will be followed for 6 months via their medical records.

Eligibility Criteria:
Inclusion Criteria:

* Patient is in HMC facility for low-acuity, Covid-positive patients being quarantined.
* Positive Covid test on qualitative assay used during routine care (i.e. not as part of Q-PROTECT)
* Age at least 18

Exclusion Criteria:

* Treating physician judges patient not appropriate for study participation for any reason
* Age \<18
* Breastfeeding or pregnancy (patient-reported pregnancy status is sufficient)
* Hypersensitivity to chloroquine or HC or AZ
* History of or known QT prolongation

  * EKG required before study entry and on each visit during the subject's first seven days on pro-tocol, during the time period HC is being taken
  * Baseline QTc \>480 if QRS width normal; QTc \>510 if QRS \>120
* Known G6PD deficiency, porphyria, or retinopathy (eye exam prior to study entry)
* Known hepatic or renal disease (or abnormality on liver or renal function testing at study day 1)
* Low magnesium or low potassium (by testing on day 1)
* Current (pre-study) therapy with antimalarial or dapsone
* Current (pre-study) therapy with antiviral agents (e.g. oseltamivir)
* Tisdale36 score exceeding 6 as tallied below (based on ACC recommendations)\*

  * 1 point each: age\>67, female sex, or being on loop diuretic
  * 2 points each: serum potassium \<3.6, QTc\>449, acute myocardial infarction
  * 3 points each: sepsis, heart failure, QT-prolonging drugs