cyrilzakka/clinical-trials huggingface dataset:
Pain Control With Total Knee Replacement

The purpose of this project is to study the effects of gabapentin on pain control in the perioperative and post-operative period of total knee arthroplasty.

Being able to understand and better control pain in patients undergoing total knee arthroplasty will help in many different areas of medicine. Gabapentin is one pain control modality that has been used by many different orthopaedic surgeons with excellent retrospective results. Gabapentin, however, has never been studied, to the investigators knowledge, in a prospective randomized fashion in the United States for total knee arthroplasty. This study will be the first of its kind to truly compare the effects of gabapentin, a drug that has been proven safe in many other areas of medicine, with placebo for total knee arthroplasty by analyzing post-operative narcotic usage, function and sleep quality.

Eligibility Criteria:
Inclusion Criteria:

* • Age \> 25 years old

  * Primary osteoarthritis of the knee
  * Must be undergoing unilateral total knee arthroplasty
  * Anesthesia assesment score I, II, or III

Exclusion Criteria:

* Severe joint malalignment (defined as varus/valgus angle \> 20 deg)

  * Use of gabapentin pre-operatively
  * History of chronic pain (currently under treatment)
  * History of substance abuse
  * Impaired kidney function (defined as creatinine \> 1.5)
  * Epilepsy (currently on medication for treatment)
  * Known allergy to Gabapentin
  * Known history of depression or suicidal thoughts and behaviors
  * Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of care.
Vaginal Profile in IVF/ICSI and Impact on Clincal Outcome

Vaginal flora is closely related to female reproductive health. Previous studies have suggested that the composition of the vaginal flora is related to the pregnancy outcomes, and abnormalities in the vaginal flora lead to a decrease in the success rate of IVF. During the IVF treatment, the hormone level changes far exceed the physiological level. What changes will happen to the vaginal flora? Does IVF treatment itself affect the vaginal flora and affect outcomes? This study used prospective cohort study to show the changes in vaginal flora during conventional IVF treatment, providing more evidence for revealing the relationship between vaginal flora and infertility treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* 20-40 years old
* BMI\<30kg/m2
* First IVF/ICSI cycle (GnRH agonist or antagonist protocol)
* no vaginitis after recruitment
* completion of oocyte retrieval

Exclusion Criteria

* history of RSA
* history of endometriosis
* Immune diseases such as SLE, etc., and the use of immunosuppressive agents, glucocorticoids, etc.
* obvious hydrosalpinx(\>2cm in diameter by ultrasound)
A Pilot Study of Constraint Induced Movement Therapy in Preschool Cerebral Palsy After Botulism Toxin Injection

To establish a pilot randomized, crossover study on applying 2 constraint-induced movement therapy (CIMT) interventions in children with hemiplegic cerebral palsy after botulinum toxin injection during preschool education.

This study was designed to be a pilot study on the use of 4-week 2-hours/day and 2-week 4-hours/day CIMT interventions in children with hemiplegic CP after a BoNT-A injection in preschool education, and compared the effects and psychological stress of CP children relative to the 2 CIMT programs.

Eligibility Criteria:
Inclusion Criteria:

hemiplegic or quadriplegic CP children were under a regular rehabilitation program with BoNT-A injections. They were classified as Gross Motor Function Classification System level I and II, aged between 3 and 6 years old, with at least below average mentality, and were in mainstream preschool education; the extension of their hemiplegic wrist and metaphalangeal joint was greater than 10 degrees.

Exclusion Criteria:

Children were excluded if they (a) could not understand or cooperate with the CIMT program, (b) had joint contracture of an upper limb, and (c) could not actively extend their hemiplegic wrist.
ECAA Brain MRI: Seeking the Link Between Extracranial Carotid Artery Aneurysms and Small Vessel Disease

In order to understand which ECAA patients benefit from medical therapy, more should be known about the possible outcomes of this rare disease. Small vessel disease seen on brain MRI's could be a good marker to assess possible silent cerebrovascular disease caused by ECAA's, suggesting underlying generalized vascular disease. With this knowledge, medical therapy for ECAA patients can be optimized and individualized to treat possible generalized vascular disease, aiding physicians in choosing a treatment strategy.

The ECAA brain MRI study is a monocenter longitudinal observational cohort study, initiated by the Department of Vascular Surgery at the University Medical Center Utrecht (UMCU), The Nederlands. The study aims to recruit 50 participants with an extracranial carotid artery aneurysm (ECAA) who are currently receiving conservative treatment. Patients will undergo MRI at baseline and after 2 years of follow-up. The expected duration of the study is approximately 3 years. The study will be conducted according to the principles of the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013). The medical ethics committee of the UMCU has approved the study. To be eligible to be included in the ECAA brain MRI, patients must be enrolled in the Carotid Aneurysm Registry (CAR, NCT02229370)

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years registered in the CAR treated with conservative therapy
* Willingness and ability to participate in all scheduled procedures outlined in the protocol
* Understanding of the Dutch language
* Patient is able and willing to give informed consent.

Exclusion Criteria:

* Inclusion criteria are not met
* Subjects registered in the CAR that have undergone surgical or endovascular treatment of the ECAA
* Contradictions for MRI, such as 1) metallic objects in or around the body (e.g. cardiac implantable electronic device such as pacemakers and implantable cardioverter defibrillators (ICD); 2) claustrophobia, 3) pregnancy.
* Other major neurological or psychiatric conditions affecting the brain and interfering with the study design (e.g. multiple sclerosis, epilepsy, Parkinson's disease, vascular dementia)
* Unable to read or write the patient information letter and broad consent file
* Patients who have a life expectancy of less than two years due to a pre-existing condition e.g. cancer
Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA

The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with GEMOX in recectable gallbladder carcinoma patients monitored by ctDNA.

Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect genetic changes or abnormalities. immuno-histochemistry tests reveal the abnormal activation status of signal pathways involved in study. These information will be used to recommend target therapy which may be more likely to result in a beneficial response. Patients will receive target antitumor agents according to the result of genomic and proteomic profiling and be monitored by circulating tumor DNA(ctDNA).

Eligibility Criteria:
Inclusion Criteria:

* Chinese#
* Stable vital signs, ECOG:0-1;
* Patients have a diagnosis of resectable gallbladder carcinoma by histopathology or cytopathology after radical surgery.
* Adequate fresh tumor tissue for genome sequencing and immunohistochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components
* Life expectancy of more than 18 weeks;
* T stage≥ T2 or histopathological lymph node positive according to AJCC (8th edition) staging.
* Adequate hepatic, hematologic and renal functions(ALT≤5×upper limit of normal (ULN), AST≤5×ULN, the Child-Pugh classification for class A or B, white blood cells≥3×10\^9/L, neutrophils≥1.5×10\^9/L, platelets≥75×10\^9/L , hemoglobin ≥ 90g/L, creatinine clearance rate≥60ml/min;
* Volunteer for this study, have written informed consent and have good Patient compliance;
* Female patients of childbearing potential and their mates agree to avoid pregnancy.

Exclusion Criteria:

* Have received following treatment before this study: a. Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months; b. lesions have been treated by irradiation; c. participate in other therapeutic or interventional clinical trials.
* History of other malignancies except carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and other malignancies for more than 5 years;
* Have serious concurrent illness including, but not limited to uncontrolled congestive heart failure(NYHA classification grade III or IV), unstable angina pectoris, unstable cardiac arrhythmias, uncontrolled moderate or serious hypertension(systolic blood pressure \>21.3 Kpa or diastolic blood pressure \>13.3 Kpa);
* Have ongoing or active serious infection;
* Have uncontrolled diabetes mellitus;
* Psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;
* Active autoimmune diseases require long-term use of steroids or received allotransplantation
* Other serious illness considered not suitable for this study by investigators.
Study Will Test the Theory That Training With the Facial-Flex Exercise Device Will Improve Snoring in Patients

The study will test the hypothesis that training with the Facial-Flex exercise device for six weeks will improve snoring in patients with primary snoring or very mild sleep apnea.

Subjects will be studied before and after 6 weeks of Facial-Flex training using portable monitoring. There will be 8 patient visits and 2 additional trips to the sleep center to return the portable sleep monitor.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of loud snoring but no observed breathing pauses by bed partner (or only very mild obstructive sleep apnea on a previous sleep study within the prior year) will be enrolled.
* Very mild sleep apnea is defined here as an apnea-hypopnea index (AHI) \< 10/hour).
* This assumes that the AHI is computed using hypopnea defined as a 30% drop in the flow signal associated with a 4% or greater arterial oxygen desaturation.

Exclusion Criteria:

* Prior upper airway surgery
* Daytime sleepiness (Epworth sleepiness scale \>12/24), (obesity BMI \> 35 kg/M2)
* Significant arterial oxygen desaturation defined as 5 minutes or more with an arterial oxygen desaturation less than 88%
* Severe insomnia with less than 4 hours of sleep per night
* Uncontrolled psychiatric disorder
* Any disorder causing facial weakness
* Pregnancy
* Temporal mandibular joint problems.
Acoustical Properties of Speech as Indicators of Suicidal Risk

This project is focused on acoustical, sound, analysis of speech in order to identify vocal characteristics of speech that are associated with suicidality. Speech samples will be collected from four populations with different mental health status: suicidal, ideational suicidal, depressed and those in remission from depression, (the control group). Speech of subjects will be recorded during routine diagnostic interview sessions. The speech samples will be acoustically analyzed via digital computer algorithms. The acoustical differences among those groups will be determined based on the statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* Age Range: 25 to 65 years of age
* Participants must be depressed or be in remission from depression (have a history of depression)

Exclusion Criteria:

* speech impediment
* intoxication at time of interview
Study Evaluating Efficiency and Tolerance of High-dose Fluconazole Associated With Flucytosine as Induction Therapy for Cryptococcal Meningitis Associated With HIV in Sub-saharan Africa

The aim of the trial is to demonstrate that in a sub-Saharan African setting, the association of:

1. Oral treatment : high dose of fluconazole (1600mg/d) associated with flucytosine (100 mg/kg/j) as induction therapy
2. lumbar punctures to control intracranial pressure

can decrease mortality rate below 35% at 10 weeks.

This is a non-randomized open label pilot study, with standardized management of cryptococcoses meningitis and follow-up in Burundi and Ivory Coast. A total of 41 patients will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* HIV Infection
* First episode of cryptococcal meningitis on basis CSF India ink and/or CSF cryptococcal antigen.
* Glasgow \> 9 after lumbar punctures
* Absence of peripheral focal deficit in the limbs
* informed consent signed

Exclusion Criteria:

* Hemoglobin \<7.5 g / dl;
* neutrophils count \<500/mm3;
* Platelets count \<50 000/mm3;
* transaminases \> 5 times upper limit of normal;
* Troubles with severe mental alertness Glasgow \<9 after the initial lumbar puncture;
* focal neurological deficit in the limbs;
* Pregnancy or lactation on going;
* Ongoing systemic antifungal treatment;
* History of cryptococcal meningitis;
* Ongoing rifampicin and ritonavir treatment;
* Subject participating in another study with a risk of mutual interference on the interpretation of results.
Fatigue Reduction Diet in Lymphoma Survivors

The purpose of this small preliminary study is to gather preliminary data to support a large randomized controlled trial of a fatigue reduction diet intervention among diffuse-large B-cell lymphoma (DLBCL) survivors. This study will provide nutritional counseling to 10 adult patients (18 years or older) with DLBCL who have completed their upfront chemotherapy treatment and remained in remission for 2 years prior to enrollment. The study will employ individualized dietary counseling, provided by a registered dietitian (RD), by phone or video teleconferencing in 8 sessions over 3 months. Dietary intake and fatigue will be assessed at baseline and 3 months. The objective of the study is to determine feasibility of the intervention and adherence to the fatigue reduction diet. Data obtained from this preliminary study would be used to support a well-powered future randomized trial of FRD vs regular diet in survivors of DLBCL.

Fatigue is highly prevalent in survivors of diffuse-large B-cell lymphoma (DLBCL). Fatigue has been linked to chronic inflammation, and diets high in antioxidant nutrients (diet rich in fruit, vegetables, whole grains, and omega-3 fatty acid-rich foods) have been associated with lesser prevalence and severity of fatigue. Studies are needed, however, to test if antioxidant-rich diets could improve fatigue in this patient population. This fatigue-reducing diet (FRD) was shown to improve fatigue and sleep in breast cancer survivors compared to regular diet. This FRD diet aligns with the standard of care dietary recommendations for cancer survivors promoted by the American Cancer Society (ACS) . The purpose of this small preliminary study is to gather preliminary data to support a large randomized controlled trial. This study will provide nutritional counseling to 10 adult patients (18 years or older) with DLBCL who have completed their upfront chemotherapy treatment and remained in remission for 2 years prior to enrollment. The study will employ individualized dietary counseling, provided by a registered dietitian (RD), by phone or video teleconferencing. Phone counseling will be weekly for the first month, and then biweekly for the next two months, for a total of 8 phone sessions. Counseling sessions take \~15-30 minutes. Dietary intake will be assessed using an electronic food frequency questionnaire at baseline and 3 months. Fatigue will be assessed using an online survey at baseline and 3 months. The purpose of the study to ascertain the percentage of patients who are able to complete all the study questionnaires and visits and adhere to the fatigue reduction diet. Data obtained from this preliminary study would be used to support a well-powered future randomized trial of FRD vs regular diet in survivors of DLBCL.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18+) with Diffuse large B-cell lymphoma (DLBCL) who have completed their upfront chemoimmunotherapy, and remained in remission for 2 years prior to enrollment

Exclusion Criteria:

* Unable to provide consent or speak English
Study of Repetitive Intestinal Lavage in Patients With EHEC Associated Hemorrhagic Colitis

The investigators examined the outcome of patients with severe Enterohaemorrhagic E. Coli (EHEC) O104:H4 infection suffering from bloody diarrhoea that were at risk to develop hemolytic uremic syndrome and underwent repetitive whole bowl lavage during hospitalization.

During the 2011 German EHEC O104:H4 outbreak, centered in the area of Hamburg, 33 patients with EHEC associated hemorrhagic colitis were admitted to the first Department of Medicine of the Hamburg University medical centre.

The first 12 patients were treated symptomatically and received intravenous rehydration up to three liters daily.

Prompted by a good clinical response after whole bowel irrigation with polyethylene glycol-solution (PEG)in patient 13 all subsequent admitted patients (n=21) were treated with PEG-solution ( 2 liters on admission followed by one liter per day during the clinical course).

During the hospital course blood work was obtained every day and patients were examined for clinical symptoms.

Thrombocytopenia below 100.000/microliter was defined as a threshold for initiating therapeutic plasmapheresis to prevent the onset of hemolytic syndrome on an early stage.

Eligibility Criteria:
Inclusion Criteria:

* Proven EHEC O104:H4-infection

Presence of bloody diarrhoea + at least one of the following serological criteria:

* platelet count below 150x10³/ μl but greater than 100x10³/ μl, serum creatine above normal level for age (\> 1.1 -1.3 mg/dl), Lactate dehydrogenase (LDH) \> 300 IU/l, leukocytosis ( \> 12x10³/ μl ) and elevated CRP (\> 5mg/l), hemoglobin \< 13.8 g/dL for male patients or \< 12.1 g/dL for female patients, respectively or decrease in haptoglobin

Exclusion Criteria:

* Bloody diarrhoea due to others reasons than EHEC O104:H4 infection
* Thrombocytopenia \< 100x10³/ μl.
* HUS, defined as platelet count below 100x10³/ μl, anaemia or decrease in haptoglobin and serum creatine above normal level for age
Safety and Efficacy of Nitric Oxide Gel in Promoting Hair Growth in Male Human Subjects With Androgenetic Alopecia

Preclinical studies showed the Nitric Oxide (NO) gel significantly promoted hair follicle formation and growth in both rat and mouse models. The NO gel induced major physiological, developmental, and structural changes in the skin of mammals to increase the number of hair follicles, follicle stem cell development and regeneration as well as hair shaft elongation, and accelerated hair growth rate. Based on our animal model findings, the investigators hypothesize that the nitric oxide releasing gel could be used as a medical treatment for hair growth in humans. The objective of this trial is to evaluate the safety and efficacy of this NO gel (XN-001), in comparison with a placebo gel in subjects in a 24-week treatment schedule.


Eligibility Criteria:
Inclusion Criteria:

1. Male subjects \>= 20 and \<= 65 years of age.
2. Subjects with hair loss caused by androgenetic alopecia.
3. Subjects who are healthy without any serious diseases that require hospitalization during the study period.
4. Subjects who are capable of understanding and having signed the Informed Consent Form after detailed description of the treatment procedures and potential risks and benefits.

Exclusion Criteria:

1. Subjects who received any treatment for hair loss within 6 months or finasteride within 12 months
2. Subjects with diagnosis of cancer and is still on active therapies.
3. Subjects with diagnosis of an active disease and is still under regular treatment for this disease
4. Subjects with hair loss caused by a known chronic disease.
5. Subjects who are on vasodilators or other medication with pharmacological actions that may lead to excessive formation of nitric oxide or may accentuate drug effects due to excessive formation of nitric oxide.
6. Subjects with thyroid disease.
7. Subjects iron-deficiency anemia.
8. Subjects with skin diseases of the scalp, including severe seborrhoeic dermatitis, psoriasis, lichenoid eruption, tinea capitis, or other scalp infections or infestations
9. Subjects with any known allergic reaction to any ingredient in the 2 gel preparations.
10. Subjects who have been enrolled into any clinical study in the preceding 6 months prior to randomization.
11. Subjects who have taken medications that are known to induce hypotrichosis or hypertrichosis.
Does Capsulectomy, Performed in Total Hip Arthroplasty With a Direct Anterior Approach Cause Knee Extension Strength Loss?

Total hip arthroplasty (THA) has been successful in relieving pain and restoring function in patients with advanced arthritis of the hip joint. Increased focus on earlier recovery and decreased postoperative pain has improved overall satisfaction. However, there is still a gap between the clinical scores in objective surveys and patient satisfaction. Direct anterior approach total hip arthroplasty has a low dislocation rate, abductor strength restoration, acceleration, and cosmetic advantages. In this method, capsulotomy with repair or capsulectomy is applied as the preferences of surgeons. Therefore, this can cause both a decrease in hip flexion strength and a loss in knee extension strength. Our aim in this study is to reveal how much muscle loss was caused by comparing both methods with the intact side.

Published data assessing biomechanical performance after THR are sparse. The majority of studies assessing post-THR hip function using robotic dynamometry have focused on evaluating surgical outcomes and prosthetic selection. These studies provide insight regarding the strength deficits of older adults after THR. However, the data are not consistent, making it difficult to assess the nature of the deficit.

Eligibility Criteria:
Inclusion Criteria:

* All primary THA

Exclusion Criteria:

* Secondary THA