cyrilzakka/clinical-trials huggingface dataset:
Bilateral Condylar Fractures Registry

Prospective data will be collected in approximately 250 patients sustaining BCFx with or without any additional fracture(s) of the symphysis. Patients will be followed according to the standard (routine) at approximately 6 weeks and 3 months after the treatment. Data collection will include fracture details (i.e. classification, mechanism of injury), treatment details, functional and patient-reported outcomes, and anticipated or procedure-related adverse events (i.e. complications).

Fractures of the condyles occur in around one third of patients sustaining a mandibular fracture. Bilateral fractures are reported in around one fifth to one third of all fractures of the mandibular condyles and are often combined with other fractures of the mandible or facial skeleton.

The treatment of condylar fractures, and in particular of bilateral condylar fractures (BCFx), is complex due to many different fracture patterns, surgeon's preferences, local constraints of the health care system and patient characteristics. Briefly, BCFx can be treated using either closed treatment (CTx) (e.g. intermaxillary fixation \[IMF\] and/or functional therapy) or surgical treatment (i.e. open reduction and internal fixation \[ORIF\]) in both fractures, or a combination of closed treatment and ORIF. The relationship of these treatments with the final outcome remains elusive, since the available literature does not report specific data for patients sustaining BCFx and has ignored or inadequately reported patient-reported outcomes. Consequently there is a lack of clinical evidence to assist the decision-making process.

Therefore, the purpose of this registry is to collect data in a standardized manner regarding the treatment, the clinical and the patient-oriented outcomes, and the complications of BCFx.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 90 years at the time of the fracture
* Diagnosis of bilateral condylar fracture of the mandible with or without a concomitant fracture of the symphysis
* Dentition: Patients must have enough maxillary and mandibular teeth present to identify proper occlusion

Exclusion Criteria:

* Unilateral condylar fracture
* Additional maxillary fracture(s)
* Polytrauma (i.e. life threatening condition)
* Patients being treated with antiresorptive drugs at the time of inclusion or during their participation in the registry
* Pregnancy
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)

The CUV156 study will evaluate the safety of afamelanotide in XP-C patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin. It will assess whether SCENESSE® increases the amount of UV light needed to cause DNA damage of skin cells, as well as the extent of skin repair before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient with a molecular-genetically confirmed diagnosis of XP-C;
* Aged 18-75 years.

Exclusion Criteria:

* Known allergy to afamelanotide or the polymer contained in the implant;
* Presence of severe hepatic disease or hepatic impairment;
* Renal impairment;
* Any other medical condition which may interfere with the study protocol;
* Female who is pregnant (confirmed by positive urine beta-Human chorionic gonadotropin pregnancy test) or lactating;
* Females of child-bearing potential (pre-menopausal, not surgically sterile) not using highly effective contraceptive measures with a failure rate of less than 1% per year when used consistently and correctly (i.e. oral contraceptives, intrauterine device) or a life-style excluding pregnancy, for up to three months after the last implant administration;
* Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who is not using highly effective contraceptive measures, as described above;
* Use of any other prior and concomitant therapy which may interfere with the objective of the study, within 30 days prior to the Screening visit;
* Participation in a clinical trial for an investigational agent within 30 days prior to the Screening visit.
CoPPer Study - Complications of Polycystic Ovary Syndrome (PCOS) Pregnancy: Evaluating Risk

The CoPPer study is a follow-up study of women diagnosed with Polycystic Ovary Syndrome (PCOS). Women will be included pre-conceptional and followed-up until after delivery. The investigators will design a multivariate prediction model of pregnancy outcome in women with PCOS with the intention to define intervention strategies for the future.

Background of the study:

PCOS is a heterogeneous condition in which metabolic disturbances such as insulin resistance are common. Pregnancies in women with PCOS are reported to have an increased chance of being complicated by gestational diabetes, pregnancy induced hypertension and pre-eclampsia. Subsequently their offspring are reported to have a lower birth weight and higher risk of admission to a neonatal intensive care unit. However, the cause of increased complication rate is not yet identified.

There is evidence that intra-uterine conditions as well as pre- and periconception factors influence not only neonatal outcome, but also long-term health of the child. Therefore early detection and treatment of pregnancy complications is important for both mother and child.

In order to identify high risk PCOS pregnancies, the specific effects of PCOS on pregnancy in comparison to the background effects need further investigation.

Preconceptional risk assessment of PCOS women is needed to improve antenatal health care and pregnancy outcome of PCOS pregnancies in the future.

Objective of the study:

To design a multivariate prediction model of pregnancy outcome in women with PCOS with the intention to define intervention strategies for the future.

Study design:

Prospective multi-centre follow-up cohort study.

Method:

Women with PCOS will be screened and included in the study pre-conceptionally. Endocrinological values, glucose tolerance and ultrasound scan etc will be recorded. During pregnancy, blood samples will be stored regularly and glucose measurement will be done. Post-partum the pregnancy outcome will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Women with PCOS
* 18 to 40 years old, who wish to conceive.

Exclusion Criteria:

* Women with anovulation that is not caused by PCOS
* Women with a language barrier
* Women under 18 or over 40 years of age will be excluded from participation.

Other exclusion criteria are:

* Unresolved medical conditions
* Established type 1 diabetes.
Effects of Home Visits on Medication Adherence in Children and Youth With HIV

Adherence to complex medication regimens is critical to successful treatment of HIV infection. Unfortunately, adherence to medical regimens with conventional interventions averages 50% in chronic disease. We have observed that adherence barriers that were unrecognized by providers in the clinic setting have been detected during home visits. It is possible that recognition and interventions to resolve adherence barriers observed during home visits may improve adherence. This proposal will test the hypothesis that home-visits which identify previously unrecognized adherence barriers and provide support and education will increase medication adherence among children and youth with HIV infection and improve the patient/health care provider relationship. Specific aims of the study are: 1. Determine the impact of a series of home-visits on adherence to medication regimens for HIV infected youth and children. 1a. Adherence to medical regimens will be assessed before and after the series of home-visits using a self-report questionnaire and Microelectronic Monitoring System (MEMS) or in-home pill count. 1b. For each of these measures a percentage of adherence will be calculated and compared from a baseline to after the final home visit and after the six month follow up period. 2. Assess the changes in patient satisfaction from baseline to after the home-visits using a questionnaire completed by the patient/family. 3. Incorporate a pilot study to assess the changes in the provider's knowledge of the patient's family characteristics and home circumstances relevant to adherence following the home visits.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* English speaking
* Live in Denver metro area
* Taking \>=1 antiretroviral medication
A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge

An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic rhinometry will be used to measure the congestion.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 19-55 years with allergic rhinitis requiring treatment within the previous 2 years.
* Subjects that respond to a ragweed nasal allergen challenge at screening.

Exclusion Criteria:

* History of asthma or FEV1 \< 80% predicted.
* Significant concomitant disease or medications.
* Symptoms of allergic rhinitis within 2 weeks prior to screening.
Low-dose IL-2 in Established T1D - The "PROREG" Study

Randomized, controlled, double-blinded, multicenter, phase I/II clinical trial to evaluate the safety of low-dose IL-2 and determine whether low-dose IL-2 therapy for one year, can prevent further loss of beta-cell function in patients with established T1D, (primary outcome). The study will carefully examine various effects of low-dose IL-2 on the immune system in patients with T1D, including effects on Treg and other cell subsets, and disease-specific autoimmune responses.

Randomized, controlled, double-blinded, multicenter, phase I/II clinical trial to evaluate the safety of low-dose IL-2 and determine whether low-dose IL-2 therapy for one year, can prevent further loss of beta-cell function in patients with established T1D, (primary outcome). The study will carefully examine various effects of low-dose IL-2 on the immune system in patients with T1D, including effects on Treg and other cell subsets, and disease-specific autoimmune responses.

Patients will be treated with ILT-101 or placebo. ILT-101 will be given at doses of 0.5 million IU (body surface area \<2 m2) or 1 million IU (body surface area \>2 m2), via subcutaneous (s.c.) injections. Patients will receive a course of 5 daily injections (days 1-5. Starting on day 15, patients will receive an s.c. injection (same dose) every 15 days for 1 year. Thus, patients will receive 29 injections during the first year of treatment. At the end of the first year, approximately half of those randomized to ILT-101 will continue receiving treatment every 15 days, until the end of the second year (23 doses). The other half will stop therapy and will be switched to a placebo.

A group of patients will be randomly assigned to a placebo for the duration of the study. Patients to be included in this study are those diagnosed with T1D who would have had T1D from 4 months to 1 year at the time of randomization, who have a current or past demonstration of autoimmunity (using autoantibodies), and maintain preserved β-cell function, defined as an MMTT stimulated C-peptide \>0.2 nmol/L. This population is chosen because it will extend the scope of therapy beyond the immediate time following diagnosis when most previous studies of immunotherapy in T1D have been conducted. This trial can further impact the field if a therapeutic benefit is shown when the disease is more established.

Eligibility Criteria:
Inclusion Criteria:

* 8-21 years of age
* T1D, demonstrated by at least one islet autoantibody
* T1D duration 4-12 months at the time of the first dose
* Peak stimulated C-peptide \>0.2 nmol/L during a 4-hour MMTT

Exclusion Criteria:

* Treatment with oral anti-diabetic agents
* Illnesses that would preclude use of low-dose IL-2
A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients

To compare stavudine (d4T) and zidovudine (AZT) in slowing the progression of HIV disease. To compare the antiviral activity of d4T versus AZT as measured by plasma levels of p24 antigen and HIV viremia, and their relative efficacy by improvement and/or absence of adverse changes over time in laboratory parameters associated with HIV infection. To compare the safety of oral doses of d4T to AZT in patients with HIV infection.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* AZT.

Patients must have:

* Documented HIV infection as determined by a positive ELISA and/or Western blot.
* Absolute CD4 count of 100 - 500 cells/mm3 within 90 days prior to registration OR a CD4 count of 50 - 99 cells/mm3 within 30 days prior to registration.
* Prior zidovudine therapy for at least 6 months and currently tolerating at least 500 mg daily.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at time of enrollment.
* Need for chronic systemic therapy at time of enrollment.
* Intractable diarrhea.
* Signs or symptoms of bilateral peripheral neuropathy at time of screening.
* Demonstrated intolerance to zidovudine therapy.
* Any other clinical conditions that would render the patient unsuitable for study or unable to comply with the dosing requirements.

Concurrent Medication:

Excluded:

* Chronic systemic therapy with agents likely to suppress bone marrow, cause neurotoxicity, or create hepatic dysfunction.

Patients with the following prior conditions are excluded:

* Prior history of bilateral peripheral neuropathy.
* Demonstrated intolerance to zidovudine therapy.

Prior Medication:

Excluded:

* Prior d4T, ddI, or ddC.
* Other investigational antiretroviral drugs (e.g., AZddU, Al 721, interferon, or immunomodulating drugs within 1 month prior to study entry or ribavirin within 3 months prior to study entry).
* Prior myelosuppressive, neurotoxic, or cytotoxic anticancer therapy within 3 months prior to study entry.
* Any prior therapy that would render the patient unsuitable for study or unable to comply with dosing requirements.

Required:

* At least 6 months of prior AZT and currently tolerating at least 500 mg daily, with the last dose received no more than 7 days prior to study entry.
Kinesio Taping in Stroke Patient

Despite being nearly independent in daily life, chronic high-functioning stroke survivors still experienced mild impairments in skilled hand function. Kinesio Taping (KT) has been used to help stroke patients improve their balance and ambulation. Few studies explored the effects of KT on fine motor function in stroke patients. The purpose of this study was to investigate the hand function performance of high-functioning stroke survivors after KT. Participants were divided into two groups: KT group and control group. Last two days, the KT group received KT intervention. After the taping was removed, baseline and post-test evaluation were conducted. Outcome measures included muscle strength, range of motion (ROM), spasticity, fine motor function, and self-reported upper limb disability. The results revealed that the KT group had less spasticity, increasing ROM trend, and improved fine motor function and disability. KT improved spasticity, active movement, and muscle flexibility, resulting in more skilled and delicate hand function in chronic high-functioning stroke survivors.


Eligibility Criteria:
Inclusion Criteria:

* (1) Stroke with unilateral hemiparesis, (2) onset duration \> 6 months, (3) Brunnstrom stage in the proximal and distal parts of the upper extremity \> stage III, and (4) adequate cognitive ability to understand and cooperate with the experiment procedure.

Exclusion Criteria:

* Participants with skin problem (such as allergies, open wound), a history of upper extremity musculoskeletal diseases (such as fractures, tendon ruptures), or other peripheral neurological or systemic diseases were excluded.
Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients with liver or bile duct cancer.

OBJECTIVES: I. Determine the response rate and toxicity of doxorubicin HCl liposome in patients with carcinomas of the liver and bile ducts.

OUTLINE: Patients receive doxorubicin HCl liposome IV over 15 minutes every 21 days. Filgrastim (G-CSF) is administered subcutaneously starting on day 2 and continuing for 10-14 days. Disease is restaged after every 3 courses. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first year, and then every 6 months thereafter.

PROJECTED ACCRUAL: There will be 17-26 evaluable patients accrued into this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the liver or bile ducts including hepatocellular carcinoma, cholangiocarcinoma, and gallbladder cancer Measurable or evaluable disease by CT scan (ascites, pleural effusions, and bone metastases are not considered evaluable)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3 mg/dL No severe cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: Left ventricular cardiac ejection fraction at least 45% Other: No allergy to egg or egg products Not pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior doxorubicin At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Not specified
Pre-approval Single-patient Expanded Access for Ritlecitinib (PF-06651600)

Provide pre-approval single patient Expanded Access (compassionate use) of Ritlecitinib for patients.

In Expanded Access, treating physicians are the Sponsors. Expanded Access requests from treating physicians may be submitted to www.pfizercares.com. Availability will depend on location and country.

Eligibility Criteria:
Must have ≥ 50% hair loss on scalp due to Alopecia Areata (AA) and be intolerant or have inadequate response to all commonly used AA therapies accessible in the country. Additional eligibility criteria may be required.
Analysis of Individual Activity at the Time of Aortic Rupture in Patients With Abdominal Aortic Aneurysms

It is currently unclear what activities aneurysms are involved in at the time of rupture. The aim of the study is to determine the activity performed at the time of aneurysm rupture.

The scientifically proven risk factors that significantly favor the rupture of an aortic aneurysm are female gender, the maximum diameter of the aortic aneurysm and the patient's current smoking status.

However, no analysis of the occupation performed at the time of aortic rupture of an abdominal aortic aneurysm has yet been carried out.

High arterial systolic blood pressure can promote aortic rupture. Blood pressure peaks can occur during physical exertion, for example when lifting heavy loads or during defecation.

Patients with an existing intact aortic aneurysm are currently advised to avoid such behaviors as a preventive measure. This includes, among other things, the practice of strength training or certain types of sport. This can subsequently lead to a reduction in quality of life, although this cannot currently be substantiated by scientific data. There is also no current guideline recommendation in this regard.

Furthermore, the role of stress and / or emotionally stressful events in connection with the occurrence of aortic ruptures has not yet been recorded in the literature. There is work on this in connection with aortic dissections, which postulates that an increase in emotional or psychological stress can lead to acute hypertension, which can cause a previously damaged aorta to rupture. A similar pathomechanism would also be conceivable for the rupture of aortic aneurysms.

There are indications that, in addition to gender-specific differences in the occurrence of aortic ruptures, there is also a different risk of rupture based on certain pre-existing conditions, dietary habits and age.

Eligibility Criteria:
Inclusion Criteria:

* inclusion of all patients with ruptured aortic aneurysm in Augsburg University Hospital
* Written consent to participate in the study by the patient or their legal representative

Exclusion Criteria:

* Lack of consent
Zika and Microcephaly: Case-control Study

It is suspected that zika virus infection during pregnancy is associated with microcephaly. The objective of this study is to investigate the occurrence of rash accompanied by three or more dengue-like signs and symptoms during pregnancy is related to the microcephaly using the case-control design.

The investigators will carry out a case-control study among mothers who delivered their babies at Nossa Senhora de Lourdes maternity hospital located in Aracaju, state of Sergipe, Brazil from September 1, 2015 through January 5, 2016. Data sources for the phase I of the study will consist of medical records review and a standard questionnaire applied by telephone to collect information about demographic features, clinical signs and symptoms, and the duration and severity of the illness. Phase II will include dengue, chikungunya and dengue serologic test results as secondary outcome, if available. The objective of this study is to investigate the occurrence of rash accompanied by three or more dengue-like signs and symptoms during pregnancy is related to the microcephaly using the case-control design

Eligibility Criteria:
Inclusion Criteria:

* Delivered a baby at nossa senhora de lourdes maternity from September 1, 2015 through january 5, 2016.

Exclusion Criteria:

* Syphilis during pregnancy, toxoplasmosis during pregnancy, consanguinity, other genetics disorder, alcohol or abuse drug consumption during pregnancy.