cyrilzakka/clinical-trials huggingface dataset:
Cerebellar rTMS for the Treatment of Schizophrenic Patients

The primary aim of this protocol is to determine whether the use of repetitive transcranial magnetic stimulation (rTMS) over vermis of the cerebellum may be safe and therapeutically effective in patients with schizophrenia. Because this is the first evaluation of this treatment in this population, the focus of this study is safety.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-65 years
2. Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist)

Exclusion Criteria:

1. Prior neurosurgical procedures
2. Any history of seizure
3. Previous head injury
4. Contraindication to TMS:

   1. Implanted pacemaker
   2. Medication pump
   3. Vagal stimulator
   4. Deep brain stimulator
   5. Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding
   6. Signs of increased intracranial pressure
5. TENS unit and ventriculo-peritoneal shunt
6. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
7. Advanced liver, kidney, cardiac, or pulmonary disease as defined clinically or a terminal medical diagnosis consistent with survival \< 1 year
8. A history of significant alcohol or drug abuse in the prior six months
9. No focal cortical insult can be present, including tumor or vascular malformation
10. Patients may not be actively enrolled in a separate intervention study
11. Patients unable to undergo a brain MR:

    a. claustrophobia refractory to anxiolytics ferromagnetic metal in the body such as a prosthetic heart valve, a pacemaker, or a brain aneurysm clip).
12. Change in antipsychotic medication during the last 4 weeks
13. Any emergency psychiatry department visit during the last 4 weeks
14. Been an inpatient in a psychiatry clinic within the last month
15. Any other axis I diagnosis
Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam

Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subject based on a complete medical history, physical examination, ECG, and clinical laboratory tests
* Age: 45 to 70 years (inclusive) at the first screening visit
* Minimum body weight 50 kg with Body mass index (BMI) above or equal to 18.5 kg/m², and below or equal to 30 kg/m² at the first screening visit
* Postmenopausal state, revealed indicated by either:

  * medical history, if applicable (natural menopause at least 12 months prior to first study drug administration, for women younger than 60 years confirmed by follicle stimulating hormone (FSH) \>40 IU/L AND estradiol ≤ 20 pg/mL; or
  * surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration)

Exclusion Criteria:

* Relevant diseases within the last 4 weeks prior to the first study drug administration, i.e. any disease requiring treatment by a health-care provider
* Febrile illness within 1 week before the first study drug administration
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Presence or history of thrombosis, thrombophlebitis, thromboembolic diseases of veins and/or arteries, e.g. deep vein thrombosis, stroke, myocardial infarction, pulmonary embolism, transient ischemic attack, angina pectoris
* Presence or history of conditions that increase the risk of thromboembolic diseases, e.g. disturbances of the coagulation system, thromboembolic diseases in close relatives at age ≤50 years\], valvular heart disease, atrial fibrillation, cardiac dysfunction)
* Presence, history, or suspected presence of malignant tumors or tumors of the liver and pituitary
* Presence or history of liver disease e.g. disturbances of the bilirubin excretion (Dubin-Johnson and Rotor syndromes), cholecystectomy ; cholestasis, idiopathic icterus or pruritus during a previous pregnancy or estrogen-progestogen treatment
* Relevant kidney diseases or renal injury associated with multisystem diseases/disorders, e.g. glomerulonephritis systemic lupus erythematous, diabetic nephropathy. A history of a single episode of uncomplicated nephrolithiasis does not prevent participation
* Known metabolic disorder, e.g. diabetes mellitus, severe hypertriglyceridemia
* Migraine with neurologic symptoms
* Clinically significant depression, current or in the last year
* Known current thyroid disorders which require treatment. Subjects with an euthyroid struma who do not need any treatment can participate.
* Chronic respiratory insufficiency
* History of porphyria
* Contraindications for midazolam, e.g. myasthenia gravis, and sleep apnea
Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders

The purpose of this research study is to test new technology-driven programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The programs focus on getting to know what's important to participants, reviewing or setting goals, and using different skills and behaviors to manage health. The study will help researchers learn about ways to deliver health information in a way that is useful and interesting.


Eligibility Criteria:
Inclusion Criteria:

* AUD
* past month heavy alcohol use
* internet access
* phone access
* able to provide informed consent

Exclusion Criteria:

* inability to speak or understand English
* conditions precluding informed consent or understanding of intervention or assessment content
* recent AUD treatment
* history of or at risk for complex alcohol withdrawal
* involvement in another ongoing study for alcohol/mental health/substance use treatment
* current cancer diagnosis/ currently receiving cancer treatment (other than skin cancers)
* PI discretion
Role of Membrane Sweeping on Initiation of Labor and Vaginal Birth in Previous Cesarean Section

In Pakistan rate of child birth through cesarean section increased from 3.2% in 1992 to 22% in 2018 .Due to increasing rates of cesarean sections and associated morbidity the investigators should focus to reduce rate of primary cesarean section as well as repeat cesarean with cephalic presentation and singleton pregnancy after previous 1 cesarean section. Therefore, all ladies who underwent previous 1 cesarean section for non-recurrent cause should be considered for vaginal birth. Though studies show that membrane sweeping does promote the onset of labor and avoid need for formal induction of labor for prolonged pregnancy but the effects of membrane sweeping in women with a prior cesarean delivery are largely unknown. This is a randomized controlled trial. Objective of the study was to determine the effect of membrane sweeping on the onset of labor, success of vaginal delivery and neonatal outcome in patients with previous one cesarean section.

World Health Organization suggests that ideally cesarean section rate should not be more than 10% to 15%. The investigators should focus to reduce rate of primary cesarean section as well as repeat cesarean with cephalic presentation and singleton pregnancy after previous 1 cesarean section. Therefore, all ladies who underwent previous 1 cesarean section for non-recurrent cause should be considered for vaginal birth. Though studies show that membrane sweeping does promote the onset of labor and avoid need for formal induction of labor for prolonged pregnancy but the effects of membrane sweeping in women with a prior cesarean delivery are largely unknown. It is reported in literature that there is no significant increase risk to maternal or neonatal outcome with membrane sweeping. The rationale of the study was to compare the effect of membrane sweeping with no sweeping in the successful onset of labor in patients with one previous Cesarean Section so that the investigators can reduce the cesarean section rate. Objective of the study was to determine the effect of membrane sweeping on the onset of labor, success of vaginal delivery and neonatal outcome in patients with previous one cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 1. Women willing for vaginal birth after lower segment cesarean section from 37 weeks of gestation to 40 weeks.

  2. Previous one caesarean section for non-recurrent cause 3. Singleton pregnancy 4. Cephalic presentation

Exclusion Criteria:

1. Previous uterine rupture
2. Major degree placenta previa
3. Any medical disorder like PIH, diabetes
4. Bad obstetrics history
Comparative Safety and Efficacy Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional

Primary Objective:

To evaluate the potential of hydratation and renewal of the mucosa, through corneometry measurement and individual questionnaire perception.

Secondary Objective:

To evaluate the safety in normal condition of use.


Eligibility Criteria:
Inclusion criteria:

* Active sex life
* Menopause for at least 6 months
* Perfect mucosa in the evaluated area
* Use the same cosmetics category

Exclusion criteria:

* Use of antiinflammatory / immunosuppression / antihistaminic drugs
* Personal history of atopy to cosmetic products
* Cutaneous active disease (local and/or general) in the evaluated area
* Disease which can cause immunosuppression, such as diabetes, HIV
* Endocrine pathology such as thyroid disease, ovarian disorder or adrenal gland
* Intense solar exposure (to get a tan) during the 15 days before the evaluation
* Gynaecologic treatment until four weeks before the evaluation
* Whatever vaginal infection detected at time of inclusion
* Other conditions considered by the investigator as reasonable to exclude the patient from the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study

Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies

The purpose of this study was to follow patients from the feeder studies who have not achieved SVR24 to assess their viral activity, and to assess the changes in liver function and disease, and post-treatment safety over time.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged ≥18
2. Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent (DAA)
3. Have not achieved SVR24

Exclusion Criteria:

1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
2. Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study
IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia

Siatalgia is one of the main symptoms related to emergency department presentations. Patients with sciatalgia are seeking for immediate pain relief and little known regarding the pain management of these patients in emergency department. This study aim to trial the effect of intravenous paracetamol and morphine in patients presented with sciatalgia to emergency department.

Siatalgia is one of the main symptoms related to emergency department presentations. Patients with sciatalgia are seeking for immediate pain relief and little known regarding the pain management of these patients in emergency department. Neuronal compression is the main cause of pain in sciatalgia rather than inflammation which also differ sciatalgia from the other type of pains in emergency department. Sciatalgia is a kind of neuralgia and there is not so much option in the pain management of these patients. Intravenous paracetamol and morphine is commonly used analgesics in various kind of pain in emergency department. So, this study aim to trial the effect of intravenous paracetamol and morphine in patients presented with sciatalgia to emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pain radiating to the sciatic nerve path
* Pain within the last one week
* Patients with positive straight leg raise
* Patients over 21 and lower than 65 years old

Exclusion Criteria:

* Pain score lower than 40 mm in visual analogue scale score
* Neurological deficit
* Allergy to the study drugs
* Unstable vital signs
* History of malignancy or rheumatological diseases or arthritis
* History of chronic pain syndrome
* Receiving pain killer, steroid, anti-depressant, anti-convulsant and musculorelaxant within the last six hours.
* Drug or alcohol addiction
* Pregnancy or breast feeding
* Fewer more than 37.9 Celsius degrees.
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"

The purpose of this study is to determine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor.

In addition, examining the safety and efficacy of alogliptin in patients with renal impairment, information on the appropriate dosage of alogliptin according to the severity of impaired renal function should be collected.

A special drug use surveillance is planned to examine the safety and efficacy of long-term use of alogliptin in patients with type 2 diabetes mellitus under the daily clinical use conditions.

Participants of this surveillance will be patients with type 2 diabetes mellitus who failed to respond adequately to diet therapy and exercise therapy alone or to a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor. The planned sample size is 3,000 subjects.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily. Participants will receive the drug as part of routine medical care.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus who have not adequately responded to any one of the following therapies:

  1. Diet therapy and exercise therapy alone
  2. In addition to diet therapy and exercise therapy, use of α-glucosidase inhibitor

Exclusion Criteria:

* Patients contraindicated for Nesina

  1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.)
  2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury (blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.)
  3. Patients with a history of hypersensitivity to any ingredient of Nesina
Sympathetic Activity in Post-injury Outcomes: Impact on Sleep and CaRdiovascular Health InvesTigation

The goal of this observational study is to learn about the long-term health of United States military service members who were injured during combat. The main questions it aims to examine are:

* How does the severity of a combat injury impact 1) cardiovascular risk, 2) the sympathetic nervous system and arrhythmias, 3) blood pressure, and 4) sleep disorders?
* Are self-reported mental health symptoms related to sympathetic nervous system hyperactivity, sleep disorders, and cardiovascular risk in combat-injured service members?

This study will recruit from a sample of participants in another research study called the Wounded Warrior Recovery Project (WWRP) who 1) agreed to be contacted about future research studies and 2) have a record of a combat injury within the Injury Severity Score ranges required for this study.

Participants will:

* Provide demographic information and a medical history review
* Visit a local laboratory for biometrics measurements and to provide blood and urine samples
* Wear an ambulatory electrocardiogram monitor for 24 hours per day for seven consecutive days
* Wear a home sleep test monitoring device for one night
* Wear a blood pressure monitor for 24 consecutive hours on the day after the home sleep test

At the end of the study, participants will be asked to mail back the home sleep test and blood pressure monitors. Prepaid package materials will be provided.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the Wounded Warrior Recovery Project (WWRP) and previously agreed to be contacted regarding future research
* Able to complete the informed consent process, be mailed study devices, and complete laboratory draws within the United States
* Age greater than or equal to 18 years

Exclusion Criteria:

* No Injury Severity Score or 3 \< Injury Severity Score \< 15
* Unable to complete the informed consent process, be mailed study devices, and complete laboratory draws within the United States
* Not enrolled in the WWRP or enrolled in the WWRP but did not agree to be contacted about future research
Yallaferon in Chinese Population

The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18.


Eligibility Criteria:
Inclusion Criteria:

* Age 25 to 65 years of age the sex life of female patients;
* High-risk HPV 16 and/or 18 positive
* Agree to sign ICF

Exclusion Criteria:

* Cervical intraepithelial neoplasia (CIN);
* Combined with a severe fungal, trichomonas vaginitis;
* Severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system;
* Allergies or allergy to the drug known ingredients.
* Within 30 days to accept other clinical trials of drugs or are participating in clinical trials;
* Pregnant and lactating women and to be pregnant women;
* The researchers do not consider it appropriate clinical trials.
Comparative Evaluation of PUSPENs and C&Cs

This observational study compares the health and social outcomes between opioid-dependent individuals who are either recently released from a compulsory drug detention center (CDDC) or recently discharged from a voluntary treatment center (VTC) providing methadone maintenance therapy, in Malaysia.

In July 2010, the National Anti-Drug Agency of Malaysia (NADA) introduced a non-punitive system of treatment and care for people who use drugs, voluntary treatment centers (VTCs), called 'Cure \& Care' clinics, offering free methadone maintenance therapy (MMT) to opioid-dependent drug users. These centers were opened alongside existing compulsory drug detention centers (CDDCs), where people who use drugs continue to be detained involuntarily without access to evidence-based treatment. Given that both of these programs are operated by NADA but espouse vastly different responses to drug use, we compared health and social outcomes between opioid-dependent individuals recently released from CDDCs and recently initiated into MMT in the new VTCs.

Eligibility Criteria:
Inclusion Criteria:

* Meets Diagnostic and Statistical Manual-IV criteria for opioid dependence
* Physically and psychologically capable of understanding and undergoing informed consent process
* Within 90 days of release or discharge and intending to return to Klang Valley region
* For VTC arm, came to the C\&C to start MMT
Interest of Plasma microRNAs

ICU acquired muscle weakness (IAMW) is a common disease that is associated with high morbidity and mortality. Patients with septic shock are particularly at risk.

The diagnosis of IAMW is clinical and based on the rating of the Medical Research Council score (MRC score). A MRC score lower than 48 defines the IAMW. But this evaluation is only usable in sufficiently awaken patients.

Several studies have highlighted the role of microRNAs in regulating physiological processes and diseases related to the skeletal muscles. To date, no study was interested in IAMW.

The aim of this study is to compare the microRNA detection kinetics on the appearance of IAMW.

In septic shock patients, the kinetics of nine microRNAs will be compared between two groups: those with IAMW (IAMW + group) and those without IAMW (IAMW - group).

MicroRNAs (miR-1, miR-21, miR-133, miR-155, miR-206, miR-208a, miR-208b, miR-486, miR-499) will be measured at day 1, day 2, day 5 and day 7 after septic shock onset.

Eligibility Criteria:
Inclusion Criteria:

Patients with septic shock criteria:

* At least two of the following criteria: temperature \< 36 ° C or \> 38 ° C, heart rate \> 90 beats / minute, respiratory rate\> 20 breaths / minute or PaCO2 \< 32mmHg, leukocytes \> 12,000 / mm3 or \< 4000 / mm3
* Refractory Hypotension (blood pressure \< 90mmHg or need norepinephrine) or lactate ≥ 4 mmol / L

Exclusion Criteria:

* Age\<18years
* Patients with preexisting neuromuscular disease
* Pregnancy
* Moribund patients with early therapeutic limitation
* Patients who had a seizure in the last 6 months
Improving Multivitamin Supplementation to Pregnant Women

The purpose of this study is to compare the tolerability of Pregvit® to a common prenatal vitamin (Orifer® F) among pregnant women with morning sickness or those suffering from a variety of conditions.

Presently, there is a large choice of perinatal vitamins on the market. Materna® is taken by 70% of Canadian women. A recent study by the investigators team has shown that up to 35%-53% of women with moderate to severe morning sickness discontinue their Materna®. One main reason is that its large size causes difficulties in swallowing, which prompts women to stop taking the drug. The second main reason for stopping is gastrointestinal adverse effects from the iron content, which causes nausea, vomiting and constipation.

A new periconceptional multivitamin supplement, Pregvit®, was introduced to the market in September 2003 by the Canadian company Duchesnay Inc. with the aim of trying to overcome the disadvantages of the existing multivitamin supplements. PregVit® is a prenatal multivitamin that contains 35 mg elemental iron, as ferrous fumarate. It is formulated into 2 small tablets (each tablet:16 mm × 9 mm × 4 mm), containing different vitamins and minerals, particularly separating the iron (morning tablet) from the calcium (evening tablet) to optimize iron absorption. The use of PregVit® requires a physician's prescription.

Since Materna® or other generic products are the most commonly used non-prescription (i.e. over-the-counter) prenatal multivitamins, they were not selected for comparison in the study because enrolled subjects who had discontinued a prenatal multivitamin most likely had discontinued any one of them. Ethically, subjects in this situation cannot be randomized to resume Materna® or another generic prenatal multivitamin.

Instead, Orifer F® was selected as the small-tablet prenatal multivitamin (one tablet: 5 mm radius, 5 mm thickness), containing a high iron content (60 mg elemental iron as ferrous sulphate). It is taken daily as a single tablet and the use of Orifer F® does not require a physician prescription (i.e. over-the-counter).

Comparing tolerability of PregVit® to Orifer F® would address separation of the potential effect of iron content from that of tablet size on multivitamin tolerability among pregnant women and women suffering from morning sickness or those suffering from a variety of conditions such as, Crohn's Disease, Ulcerative Colitis, Peptic-Duodenal Ulcer, Irritable Bowel Syndrome, Celiac Disease, as well as anemia or hypothyroidism.

Eligibility Criteria:
Inclusion Criteria:

Any woman who discontinued her standard vitamins due to gastrointestinal symptoms or due to the tablet size, with one ofthe following conditions:

* Morning sickness.
* Gastrointestinal disorders: Crohn's disease, ulcerative colitis, peptic or duodenal ulcer, irritable colon, celiac disease.
* Iron deficiency anemia.
* Hypothyroidism.
* Depression.

Exclusion Criteria:

* Women who do not agree to consent to this protocol.
* Women with a known hypersensitivity to any of the ingredients of Pregvit®, or Orifer® F.